CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 OCTOBER 11-14, 2017 CHICAGO, ILLINOIS SWOG Leading cancer research. Together.

Chicago

SWOG FALL 2017 GROUP MEETING 1 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

2 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Improvement Through Innovation

Innovation, simply put, is trying Innovation is not only our group meeting theme for 2017. It’s also something we’ve been living all year long something new. It’s the heart of our work. here at SWOG. In January, we submit our next five-year Or maybe the soul. With each and every NCTN grant request. It’s a recounting of what we’ve trial, we’re testing a new treatment or achieved since 2014, and what we plan to achieve through 2024. At this meeting, I’ll meet with my prevention strategy, or trying to improve leadership team for the last time, in person, to review quality of life for survivors. our grant strategy and writing progress. Planning for the future is exciting, and I’ve never Some trials really push that boundary, using new felt better about where SWOG is, and where we are science or new designs or new classes of drugs. headed. Palliative care, immunotherapy, diversity, We’ve done all that in the last year, becoming the first digital engagement – our new directions are going to group in the NCI’s National Clinical Trials Network lead us to good destinations. For our members – and to activate a financial toxicity trial and the first most importantly, our patients. immunotherapy trial for rare cancers. As always, thanks for your commitment to SWOG and our clinical This spring, we heard about our most innovative treatment trials. Enjoy the meeting here in Chicago. trials. Here in Chicago, we’ll hear about our most ground-breaking trials arising in our survivorship and prevention and epidemiology committees.

3 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 “ I’m privileged to provide the patient perspective on our SWOG “Myeloma Committee and appreciate Hope’s critical support. Helping SWOG Do More SWOG formally invited patient advocates into its research activities in 1993, the same year The Hope Foundation was established. Since that time, Hope has continually funded travel and professional development to further advocates’ important work. Text “SWOG” to 41444 to give today. Jack Aiello, MS, EE SWOG Patient Advocate, 25 Years of Myeloma Committee Supporting SWOG

4 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 “ CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Group Meeting Index

Plenary Sessions ...... 6, 17 & 19 The Hope Foundation ...... 4 & 21 CME Credit Information ...... 8 & 9 Group Meeting Supporters ...... 9 & 71 Hyatt Regency Travel and Hotel Information and Hotel Maps . . . . . 12-15 Schedule of Events ...... 16-19 Committee Information: Adolescent and Young Adult (AYA) Committee ...... 17 Barlogie-Salmon Myeloma Committee ...... 18 & 23-24 Breast Committee ...... 19 & 25-29 Board of Governors ...... 19 Bone Marrow & Stem Cell Transplantation Committee ...... 18 Cancer Care Delivery Committee ...... 17 & 32-33 Cancer Survivorship Committee ...... 17 & 34 Committee Chairs ...... 19 Digital Engagement Committee ...... 17 Early Therapeutics & Rare Cancers Committee ...... 17 & 40-41 Gastrointestinal Committee ...... 19 & 42-45 Genitourinary Committee ...... 19 & 46-49 Imaging Committee ...... 18 Leukemia Committee ...... 19 & 50-53 Lung Committee ...... 17 & 54-57 Lymphoma Committee ...... 19 & 58-59 Melanoma Committee ...... 18 & 60-63 Patient Advocate Committee ...... 16 & 17 Pharmaceutical Sciences Committee ...... 19 Prevention & Epidemiology Committee ...... 17 & 35-36 Publications Committee ...... 18 Radiation Oncology Committee ...... 19 Surgery Committee ...... 7 & 18 Symptom Control & Quality of Life Committee ...... 18 & 37-39 Jeri and Noboru Oishi Symposium ...... 16 Oncology Research Professionals (ORP) Open Forum ...... 17 Administrative and Research Committees ...... 22 Future Group Meeting Dates ...... 22 Special Symposia & Events ...... 20-21 SWOG Publications ...... 64-70

5 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Plenary Part I Plenary Part II The fall meeting’s translational medicine plenary The fall meeting’s general plenary will take place will take place Thursday, October 12, 3:00-4:30 Friday, October 13, 12:00-2:00 p.m., in Regency A-C. p.m., in Regency A-C. Speakers and topics include the following:

Welcome and Introduction Chair’s Welcome and Update The Growing Landscape Lee M. Ellis, MD Charles D. Blanke, MD of Palliative Care SWOG Vice Chair for SWOG Chair Dr. Harry E. Hynes Memorial Lecture Translational Medicine Oregon Health & Science Jeannine M. Brant, PhD, University of Texas University APRN, AOCN, FAAN M.D. Anderson Cancer Center Oncology Clinical Nurse Specialist Harnessing the Power of Genomics Innovation in SWOG NCORP Trials Nurse Scientist in Correlative Studies Katherine D. Crew, Pain Consultant MD, MS Billings Clinic Elaine R. Mardis, PhD Cancer Care Delivery Lead Nationwide Foundation Associate Professor of Medicine Montana Cancer Consortium Endowed Chair in Genomic and Epidemiology Medicine Division of Hematology/ Co-Executive Director, Institute Oncology for Genomic Medicine at Director, Clinical Breast Cancer Nationwide Children’s Hospital Prevention Program Professor of Pediatrics Herbert Irving Comprehensive The Ohio State University Cancer Center College of Medicine​ Columbia University Medical Center Liquid Biopsies…What’s Next? Luis Diaz, Jr., MD Innovation in Cancer Clinical Trials: Head, Division of Solid Tumor How Are Trials Improved If Everyone Is Involved in the Medical Research Process? Oncology Larry Chu, MD Alicia C. Staley, MBA Department of Medicine Executive Director Director of Patient Engagement Memorial Sloan Kettering Stanford Medicine X Science 37 Cancer Center Professor Co-Founder Stanford University Breast Cancer Social Media Understanding the Secrets of the SWOG Tissue Bank Nilsa C. Ramirez, MD, FCAP Contact Principal Investigator, SWOG Biospecimen Bank Professor of Clinical Pathology The Ohio State University College of Medicine Nationwide Children’s Hospital

6 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

SWOG Surgical Protocols Educational Session: Surgery Committee OCTOBER 13, 2017 9:00 – 11:00 A.M.

S1316: Prospective Comparative Effectiveness Trial E S1600 SIMmune: A Randomized Phase III Double-Blind for Malignant Bowel Obstruction Clinical Trial Evaluating the Effect of Immune-Enhancing Virginia Sun, PhD, RN Nutrition on Radical Cystectomy Outcomes Assistant Professor, Division of Nursing Research and Education Jill Hamilton-Reeves, PhD, RD, CSO Department of Population Sciences & Cancer Control and Associate Professor Population Sciences Program Department of Urology and Dietetics/Nutrition City of Hope University of Kansas Medical Center

A Personalized Dietary Intervention Trial Evaluating the Oncologic Safety for Bowel Dysfunction in Rectal Cancer Survivors of Laparoscopic versus Open Liver Resection Virginia Sun, PhD, RN Claudius Conrad, MD Department of Surgical Oncology, MD Anderson Cancer Center Update on S1011: comparing extended vs. standard lymphadenectomy with Hyperthermic Intraperitoneal Chemotherapy and Systemic radical Cystectomy for invasive Bladder cancer Chemotherapy versus Systemic Chemotheray Alone for High Seth Paul Lerner, MD Volume Peritoneal Carcinomatosis of Colorectal Origin Professor, Department of Urology Jig Deneve, DO FACS Baylor College of Medicine Assistant Professor of Surgery UTHSC, Memphis, TN Update: S0820: A Double Blind Randomized Placebo-Controlled Trial of DFMO and Sulindac to Prevent Recurrence of Adenomas in Patients with Stages I-III Colon and Rectal Cancer, Phase III Jason A. Zell, DO, MPH Associate Professor, Division of Hematology/Oncology, Departments of Medicine & Epidemiology University of California, Irvine

7 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 New Procedures for CME Credit

Available Actual We’ve gone paperless! SWOG no Time Session Title Credit Credit longer requires members to submit THURSDAY, OCTOBER 12, 2017 paper forms to obtain CME credits. 8:00 a .m . – 10:00 a .m . Cancer Survivorship Committee 2 .0 Getting your credits online is easy: 10:00 a .m . – 12:15 p .m . Early Therapeutics & Rare Cancers Committee 2 .25 10:15 a .m . – 12:15 p .m . Cancer Care Delivery Committee 2 .0 • Visit: http://swog.org/Members/ 12:30 p .m . – 2:30 p .m . Prevention and Epidemiology Committee 2 .0 CMECertification.asp 3:00 p .m . – 4:30 p .m . Plenary I (Translational Medicine) 1 .5 • Complete the evaluation questions 4:45 p .m . – 7:45 p .m . Lung Committee 3 .0 • Enter the credits being claimed FRIDAY, OCTOBER 13, 2017 • Press “submit” 7:30 a .m . – 9:30 a .m . Barlogie-Salmon Myeloma Committee 2 .0 Your certificate will automatically be 7:30 a .m . – 9:30 a .m . Symptom Control and Quality of Life Committee 2 .0 emailed to you. 9:00 a .m . – 11:00 a .m . Surgery Committee 2 .0 9:30 a .m . – 11:30 a .m . Melanoma Committee 2 .0 Problems or questions? Contact 12:00 p .m . – 2:00 p .m . Plenary II (General) 2 .0 Courtney Wille in the SWOG operations 4:00 p m. . – 7:00 p .m . Lymphoma Committee 3 .0 office at [email protected]. 4:30 p .m . – 6:30 p .m . GI Committee 2 .0

To keep track of your credits during the SATURDAY, OCTOBER 14, 2017 meeting, use the form on the next page. 9:30 a .m . – 11:30 a .m . Radiation Oncology Committee 2 .0 9:30 a .m . – 11:30 a .m . Leukemia Committee 2 .0 9:30 a .m . – 12:30 p .m . GU Committee 3 .0 9:30 a .m . – 12:30 p .m . Breast Committee 3 0.

Total Possible Credits 22.75

8 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Procedures for CME Credit Group Meeting Target Audience and Educational Objectives SWOG gratefully SWOG meets semi-annually to keep its members abreast of group acknowledges the science . The target audience for these meetings are physicians, nurse oncologists and clinical research associates . support of our The educational objectives of these meetings are: to educate CME Commercial PLATINUM attendees about active and proposed studies so that they may Supporters* implement the studies at their local institutions; to educate Celgene attendees about new treatments and prevention strategies that are Eli Lilly & Co. available; to identify areas that can be improved in cancer research and study implementation and educate attendees on the best ways to implement the solutions at the local level . These objectives apply to the following areas: Cancer Control and Prevention, including Cancer Care Delivery Committee, Symptom Control and Quality of Life Committee, Prevention & Epidemiology Committee, Cancer Survivorship Committee; Genitourinary GOLD SILVER Committee; Early Therapeutics & Rare Cancers Committee; Myeloma AbbVie Committee; Melanoma Committee; Surgery Committee; Radiation AstraZeneca Oncology Committee; Plenary Sessions Part I and II; Leukemia Novartis Genomic Health Committee; Breast Committee; Gastrointestinal Committee; Lung Merck Committee, and Lymphoma Committee . * Supporters as of Sept. 18, 2017 Continuing Medical Education Credit The Hope Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians . We’ve gone paperless! SWOG no longer requires The Hope Foundation designates this live activity for a maximum of 22 75. AMA PRA Category 1 Credits™ . Physicians should only claim members to submit paper forms to obtain CME credits. credit commensurate with the extent of their participation in the Getting your credits online is easy: activity . l Visit: http://swog.org/Members/CMECertification.asp l Complete the evaluation questions l Enter the credits being claimed Speaker and Planner CME Disclosure Information l Press “submit” Each speaker and planner for The Hope Foundation — CME courses has been requested to complete a Faculty Disclosure Form prior to the activity Your certificate will automatically be emailed to you. in accordance with ACCME standards. THF strives to provide accurate Problems or questions? Contact Courtney Wille in the and up-to-date information regarding affiliations or interests that might SWOG operations office at [email protected]. be perceived as a potential conflict of interest for those who control CME content. Please see the disclosure handout available at the SWOG self- To keep track of your credits during the meeting, use service and onsite registration desks. Best attempts will also be made to the form below. provide up to date information on introductory slides at each CME session.

9 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 We’re now on Facebook

We’ve launched a private Facebook group — SWOG Oncology — to create an online meeting place for every SWOG member .

Join the group and you’ll Public PoweredPublic Powered Cancer CancerResearch Research get news from SWOG and funding alerts from The Hope Foundation . You can also talk clinical trial triumphs and troubleshooting, picking up best practices and getting advice on study challenges .

It’s easy to sign up .

Log onto Facebook, search for “SWOG Oncology” and hit the green “Join Group” button . You’ll get a notification when your access is approved .

SWOG Leading cancer research. Together. Tweet the meeting Tag your group meeting tweets with #swogonc We’ll post the live stream of tagged group meeting updates to the SWOG website, for ease of following by those who couldn’t make it .

Follow SWOG at twitter.com/SWOG . Our username is @SWOG .

10 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 We’re launching a new website! By the end of the year, the new SWOG org. will go live – our first l SWOG statistics major website redesign . The updated daily entire site has been redesigned, rewritten, and rebuilt based on l Easy single-step member feedback . login Improvements include: l Improved l One-step login search tools l Easier navigation

l l Improved member directory News and announcements l Improved trial and publications search tool

l Handy member resource page

l Member stories

l Patient testimonials

l New videos

Visit SWOG org. to learn more about getting new login credentials through CTEP or SWOG .

We want you to access all the new online tools, news, and l Special member information! resources

l Better connection to The Hope Foundation

11 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Chicago Travel & Hotel Information Hyatt Regency Chicago 151 East Wacker Drive Chicago, Illinois 60601 l Phone: 312-565-1234 l Fax: 312 239 4541

Arrival/Departure: Check-in time is 3:00 p.m. Check-out time is 12:00 noon. Room amenities include a full bath, hair dryer, ironing board and iron. The concierge staff serves as a liaison between guests and the hotel and outside services. Hotel Safety Deposit Boxes: For your convenience, safety deposit boxes are available at the front desk for your valuables. Please do not leave valuables in your room. Recreational Facilities: The fitness center offers a variety of exercise equipment, free weights, treadmills, and more, exclusively for hotel guests. It is open 24 hours a day. Hotel Restaurants and Lounges: Stetsons Modern Steak & Sushi: Non-traditional steakhouse experience in a comfortable urban setting, specializing in steaks and seafood. Restaurant is open daily from 5:00 p.m. - 11:00 p.m. American Craft Kitchen & Bar: Regionally inspired by all corners of the country, they offer an approachable dining experience with handcrafted food and drink. This atrium restaurant is the perfect stop for breakfast or lunch. Open daily from 6:00 a.m. - 3:00 p.m. Market Chicago: Offers breakfast, lunch or dinner for a quick meal or coffee to go. Open 24 hours a day. DaddyO’s Pub & Game Room: Corner pub featuring juicy burgers, local brews and wall-to-wall entertainment. Open 5:00 p.m. - 1:00 a.m. The BIG Bar features the longest free-standing bar in North America and specializes in a wide variety of cocktails, wines, champagnes and cognacs and snacks. Open daily at 5:00 p.m. In-room dining is available from 6:00 a.m. - 12:00 a.m. daily. Business Center: The Business Center is located on the Purple level in the East Tower of the hotel. It is open 24 hours a day, 7 days a week. The Business Center offers fax machines, computer services, color copies, mail drop, Internet access and photocopying.

12 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Chicago Travel & Hotel Information, cont.

Ground Transportation: A taxi ride from O’Hare International Airport to the hotel is approximately $35.00 one-way. A taxi ride from Midway International Airport to the hotel is approximately $30.00 one-way. Valet parking at the hotel is a maximum of $65.00 per day for hotel guests. Temperature: The average high for September is 75 degrees and the average low is 54 degrees. AREA ATTRACTIONS: l Adler Planetarium and Astronomy Museum

l Architectural Boat Tours

l Art Institute of Chicago

l Brookfield Zoo

l Chicago ArchiCenter

l Chicago Architecture Foundation

l Chicago Botanic Garden

l Field Museum of National History

l John G. Shedd Aquarium

l John Hancock Center Observatory

l Millennium Park

l Museum of Contemporary Art

l Museum of Science and Industry

l Rockefeller Memorial Chapel

l Sears Tower Skydeck Local Restaurants: (The hotel concierge can assist with reservations and suggestions)

l Alinea - Eclectic

l Atwood Cafe - American

l Mia Francesca - Italian

l Mon Ami Gabi - French

l Shaw’s Crab House and Blue Crab Lounge - Seafood

l Spiaggia - Italian

13 SWOG Leading cancer research. Together. HYATT REGENCY CHICAGO GUEST MAP

WELCOME TO HYATT REGENCY CHICAGO. Meeting rooms, ballrooms, restaurants and guest amenities are listed in alphabetical order and color coded byCHICAGO, floor. ILLINOIS For help, | OCTOBER dial 11-14, Guest 2017 Services at Extension 4460.

ACAPULCO (International and City Suites) HONG KONG (International and City Suites) West Tower, Ballroom Level West Tower, Ballroom Level

ADDAMS (Founders Suites) HORNER (Founders Suites) West Tower, Third Floor West Tower, Third Floor AMERICAN CRAFT KITCHEN & BAR THE LIVING ROOM WELCOME TO HYATT East Tower, Lobby Level West Tower, Skyway Level

REGENCY CHICAGO. ATLANTA (International and City Suites) MARKET CHICAGO EAST TOWER WEST TOWER Meeting rooms, ballrooms, West Tower, Ballroom Level East Tower, Lobby Level BELL DESK MCCORMICK (Founders Suites) restaurants and guest East Tower, Skyway Level West Tower, Third Floor

amenities are listed in BIG BAR MICHIGAN (Lakeshore Meeting Rooms) East Tower, Skyway Level East Tower, Concourse Level THIRD FLOOR alphabetical order and BURNHAM (Founders Suites) MONROE (Lakeshore Meeting Rooms) Silver Level color coded by floor . For West Tower, Third Floor East Tower, Concourse Level

help, dial Guest Services at BUSINESS CENTER, PACKAGE ROOM NEW ORLEANS (International and City Suites) East Tower, Exhibit Level West Tower, Ballroom Level FOUNDERS SUITES Extension 4460. SKYWAY LEVEL SKYWAY MEETING ROOMS COLUMBIAN (Landmark Suites) OGDEN (Founders Suites) Blue Level West Tower, Concourse Level West Tower, Third Floor

COLUMBUS HALL (ROOMS A-L) PICASSO (Landmark Suites) East Tower, Ballroom Level West Tower, Concourse Level

COMISKEY (Landmark Suites) PLAZA BALLROOM West Tower, Concourse Level East Tower, Lobby Level FRONT DESK THE GALLERY BELL DESK CONCIERGE RANDOLPH (Lakeshore Meeting Rooms) BIG BAR SKYBRIDGE COLLECTION BETWEEN THE LIVING ROOM East Tower, Lobby Level East Tower, Concourse Level TOWERS CRYSTAL BALLROOM REGENCY BALLROOM West Tower, Lobby Level West Tower, Ballroom Level FITNESS CENTER LOBBY LEVEL DUSABLE (Founders Suites) RIVERSIDE CENTER Green Level West Tower, Third Floor East Tower, Exhibit Level PLAZA BALLROOM STETSONS MODERN STEAK + SUSHI EAST TOWER MAIN ENTRANCE ROOSEVELT (Lakeshore Meeting Rooms) AMERICAN CRAFT East Tower, Lobby Level East Tower, Concourse Level KITCHEN & BAR EAST TOWER VALET SAN FRANCISCO (International and City Suites) CRYSTAL FOYER East Tower, Ballroom Level West Tower, Ballroom Level MARKET CHICAGO WEST TOWER CONCIERGE MAIN ENTRANCE HERTZ FIELD (Founders Suites) SANDBURG (Founders Suites) EAST TOWER CRYSTAL BALLROOM West Tower, Third Floor West Tower, Third Floor MAIN ENTRANCE FITNESS CENTER SKYWAY MEETING ROOMS West Tower, Skyway Level East Tower, Skyway Level WACKER DRIVE FRONT DESK SOLDIER FIELD (Landmark Suites) East Tower, Skyway Level West Tower, Concourse Level THE GALLERY COLLECTION STETSON CONFERENCE CENTER CONCOURSE LEVEL West Tower, Skyway Level West Tower, Exhibit Level Bronze Level LAKESHORE MEETING ROOMS GIFT SHOP STETSONS MODERN STEAK + SUSHI East Tower, Concourse Level East Tower, Lobby Level CONCOURSE BETWEEN GOLD COAST (Landmark Suites) TORONTO (International and City Suites) GIFT SHOP TOWERS West Tower, Concourse Level West Tower, Ballroom Level LANDMARK SUITES GRAND BALLROOM WATER TOWER (Landmark Suites) East Tower, Ballroom Level West Tower, Concourse Level COLUMBUS HALL BALLROOM LEVEL GRAND SUITES WEST TOWER VALET Gold Level East Tower, Ballroom Level West Tower, Exhibit Level GRAND BALLROOM INTERNATIONAL A GRAND BALLROOM HAYMARKET WRIGHT (Founders Suites) REGISTRATION (Landmark Suites) AND CITY SUITES B West Tower, Concourse Level West Tower, Third Floor GRAND SUITES REGENCY REGENCY EAST TOWER C HERTZ WRIGLEY (Landmark Suites) BALLROOM BALLROOM West Tower, Concourse Level VALET REGISTRATION East Tower, Lobby Level D

14 RIVERSIDE EXHIBIT STETSON RIVERSIDE SWOG Leading cancer research. Together. LEVEL ENTRANCE EAST CONFERENCE Purple Level CENTER RIVERSIDE CENTER RIVERSIDE ENTRANCE WEST WEST TOWER VALET BUSINESS CENTER PACKAGE PICK-UP

ELEVATORS

ESCALATORS ESCALATORS, ELEVATORS AND RESTROOMS are indicated on each floor. Elevators are AND STAIRS conveniently located throughout the hotel for guests with disabilities or where no escalator is present. RESTROOMS CROSSING BETWEEN TOWERS: Cross between towers via the Skybridge or the Concourse . You may also cross from the lobby level via the crosswalk on Stetson Drive. MOTHER’S ROOM CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

EAST TOWER WEST TOWER

THIRD FLOOR Silver Level

FOUNDERS SUITES SKYWAY LEVEL SKYWAY MEETING ROOMS Blue Level

BELL DESK FRONT DESK THE GALLERY BIG BAR SKYBRIDGE COLLECTION BETWEEN THE LIVING ROOM TOWERS

LOBBY LEVEL FITNESS CENTER Green Level PLAZA BALLROOM STETSONS MODERN STEAK + SUSHI AMERICAN CRAFT KITCHEN & BAR

CRYSTAL FOYER MARKET CHICAGO WEST TOWER CONCIERGE MAIN ENTRANCE HERTZ EAST TOWER CRYSTAL BALLROOM MAIN ENTRANCE

WACKER DRIVE

CONCOURSE LEVEL Bronze Level LAKESHORE MEETING ROOMS

CONCOURSE BETWEEN GIFT SHOP TOWERS LANDMARK SUITES BALLROOM LEVEL COLUMBUS HALL Gold Level A GRAND BALLROOM GRAND BALLROOM INTERNATIONAL REGISTRATION AND CITY SUITES B GRAND SUITES REGENCY C REGENCY EAST TOWER BALLROOM BALLROOM VALET REGISTRATION D

RIVERSIDE EXHIBIT RIVERSIDE STETSON LEVEL ENTRANCE EAST CONFERENCE Purple Level CENTER RIVERSIDE CENTER RIVERSIDE ENTRANCE WEST WEST TOWER VALET BUSINESS CENTER PACKAGE PICK-UP

ELEVATORS

ESCALATORS ESCALATORS, ELEVATORS AND RESTROOMS are indicated on each floor. Elevators are AND STAIRS conveniently located throughout the hotel for guests with disabilities or where no escalator is present. RESTROOMS CROSSING BETWEEN TOWERS: Cross between towers via the Skybridge or the Concourse . You may also cross from the lobby level via the crosswalk on Stetson Drive. MOTHER’S ROOM

15 SWOG Leading cancer research. Together. Meetings in all caps CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 receive CME credits Schedule of Events

Order of Levels (top to bottom): Skyway Level | Lobby Level | Concourse Level | Ballroom Level | Riverside Exhibit Level

Wednesday, October 11, 2017 5:30 P.M. – 7:30 P.M. Acapulco, Ballroom Level, West Tower Site Operations Group Meeting Registration & Information Desk (Formerly Head 1:00 p.m. - 5:00 p.m. - Regency Foyer, CRA – Open Session) Ballroom Level, West Tower 5:30 P.M. – 8:00 P.M. Regency C, Ballroom Level, West Tower NCORP Research Base 8:00 A.M. – 12:00 P.M. Executive Committee Meeting (Committee Wrigley, Concourse Level, West Tower Grant Retreat (Executive Leadership/ Members Only) Invitation Only) 6:30 P.M. – 8:30 P.M. 10:00 A.M. – 12:00 P.M. Haymarket, Concourse Level, West Tower ITSC Steering Committee (Committee Soldier Field, Concourse Level, West Tower ORP Executive Committee (Committee Members Only) Members Only) 12:00 P.M. – 1:45 P.M. Thursday, October 12, 2017 Haymarket, Concourse Level, West Tower Nursing Research Group Meeting Registration & Information Desk Subcommittee 7:00 a.m. - 5:00 p.m. - Regency Foyer, 12:00 P.M. – 2:00 P.M. Ballroom Level, West Tower Water Tower, Concourse Level, West Tower Core Office Staff Meeting (Invitation Hope Foundation Information Desk Only) 8:00 a.m. - 5:00 p.m. - Regency Foyer, 1:00 P.M. - 5:00 P.M. Ballroom Level, West Tower Gold Coast, Concourse Level, West Tower SoCRA Certification Examination Exhibits & Complimentary Coffee Service 1:00 P.M. - 5:00 P.M. 7:00 a.m. - 4:00 p.m. - Toronto/Hong Kong, Regency B, Ballroom Level, West Tower SWOG NCORP Research Ballroom Level, West Tower Base Clinical Trials Workshop 7:00 A.M. - 8:00 A.M. 2:00 P.M. – 3:30 P.M. New Orleans, Ballroom Level, West Tower Advocates Committee Soldier Field, Concourse Level, West Tower SWOG Tissue Banking Meeting (Committee Meeting (Invitation Members Only) Only) 7:30 A.M. – 8:00 A.M. 3:00 P.M. – 4:30 P.M. Regency B, Ballroom Level, West Tower Jeri & Noboru Oishi Water Tower, Concourse Level, West Tower Task Force on Palliative Symposium Check-In Medicine and Advance 8:00 A.M. – 12:00 P.M. Care Planning Regency AB, Ballroom Level, West Tower Jeri & Noboru Oishi 3:30 P.M. - 5:30 P.M. Symposium (Open Session) Wrigley, Concourse Level, West Tower Hope Foundation Board Meeting (Board 8:00 A.M. - 9:00 A.M. Members Only) Haymarket, Concourse Level, West Tower Professional Review 4:30 P.M. – 5:30 P.M. Committee (Committee Members Only) Comiskey, Concourse Level, West Tower ORP Liaison Subcommittee

16 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Meetings in all caps CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 receive CME credits Schedule of Events

Order of Levels (top to bottom): Skyway Level | Lobby Level | Concourse Level | Ballroom Level | Riverside Exhibit Level

8:00 A.M. – 10:00 A.M. 12:30 P.M. – 2:30 P.M. Regency D, Ballroom Level, West Tower CANCER SURVIVORSHIP Regency D, Ballroom Level, West Tower PREVENTION AND COMMITTEE EPIDEMIOLOGY COMMITTEE 12:30 P.M. – 2:30 P.M. 8:00 A.M. – 10:00 A.M. San Francisco, Ballroom Level, West Tower Lung-MAP Site Water Tower, Concourse Level, West Tower Lung Working Group Coordinators (Working Group Committee Meeting Members Only) (Committee Members 1:00 P.M. – 3:00 P.M. Only) New Orleans, Ballroom Level, West Tower Lymphoma Working 9:00 A.M. – 10:00 A.M. Group Meeting Soldier Field, Concourse Level, West Tower Lung Surgery (Working Subcommittee Group Members Only) (Committee Members 2:00 P.M. – 3:00 P.M. Only) Regency Foyer, Ballroom Level, West Tower Plenary Reception 9:00 A.M. – 10:00 A.M.

Regency C, Ballroom Level, West Tower S1609 DART Protocol 2:00 P.M. – 3:00 P.M. Meeting Soldier Field, Concourse Level, West Tower ORP Education 10:00 A.M. – 12:00 P.M. Subcommittee Water Tower, Concourse Level, West Tower Digital Engagement Committee (Committee 3:00 P.M. – 4:30 P.M. Members Only) Regency A-C, Ballroom Level, West Tower PLENARY I (TRANSLATIONAL 10:00 A.M. – 12:00 P.M. MEDICINE) Haymarket, Concourse Level, West Tower Quality Initiative Meeting (Committee 3:00 P.M. – 4:30 P.M. Members Only) San Francisco, Ballroom Level, West Tower Advocates Committee Meeting (Committee 10:00 A.M. – 12:15 P.M. Members Only) Regency C, Ballroom Level, West Tower EARLY THERAPEUTICS AND RARE CANCERS 4:45 P.M. – 6:45 P.M. COMMITTEE Water Tower, Concourse Level, West Tower Breast Translational Medicine Working 10:15 A.M. – 12:15 P.M. Group (Working Group Regency D, Ballroom Level, West Tower CANCER CARE Members Only) DELIVERY COMMITTEE 4:30 P.M. – 7:30 P.M. 10:30 A.M. – 11:30 A.M. Comiskey, Concourse Level, West Tower Myeloma Working Soldier Field, Concourse Level, West Tower Lung Radiation Group Meeting Subcommittee (Working (Committee Members Group Members Only) Only) 4:45 P.M. – 7:45 P.M. 12:00 P.M. – 2:00 P.M. Regency D, Ballroom Level, West Tower LUNG COMMITTEE Comiskey, Concourse Level, West Tower Adolescent and Young Adult (AYA) Committee 5:00 P.M. – 6:30 P.M. New Orleans, Ballroom Level, West Tower Eagle II Reception 12:30 P.M. – 2:00 P.M. (Invitation Only) Acapulco, Ballroom Level, West Tower ORP Open Forum

17 SWOG Leading cancer research. Together. Meetings in all caps CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 receive CME credits Schedule of Events

Order of Levels (top to bottom): Skyway Level | Lobby Level | Concourse Level | Ballroom Level | Riverside Exhibit Level

5:00 P.M. – 7:00 P.M. 7:30 A.M. – 9:30 A.M. Acapulco, Ballroom Level, West Tower Seminar: Developing Regency D, Ballroom Level, West Tower SYMPTOM CONTROL Cultural Competence in AND QUALITY OF LIFE Clinical Trials Research COMMITTEE 5:00 P.M. – 7:00 P.M. 7:30 A.M. – 9:30 A.M. Haymarket, Concourse Level, West Tower Conflict Management San Francisco, Ballroom Level, West Tower SWOG Data and Safety Committee (Committee Monitoring Committee Members Only) (Committee Members Only) 5:30 P.M. – 6:30 P.M. 9:00 A.M. – 10:00 A.M. Gold Coast, Concourse Level, West Tower S1316 Protocol Meeting Crystal C, Lobby Level, West Tower S1602 and S1605 Joint 7:00 P.M. – 9:00 P.M. Protocol Meeting Gold Coast, Concourse Level, West Tower Latin American Symposium 9:00 A.M. – 11:00 A.M. (Invitation Only) Acapulco, Ballroom Level, West Tower SURGERY COMMITTEE 9:30 A.M. – 11:30 A.M. Friday, October 13, 2017 Crystal B, Lobby Level, West Tower MELANOMA Group Meeting Registration & Information Desk COMMITTEE 7:00 a.m. - 5:00 p.m. - Regency Foyer, 9:30 A.M. – 11:30 A.M. Ballroom Level, West Tower Randolph 3, Concourse Level, East Tower Leadership Academy (Invitation Only) Hope Foundation Information Desk 10:00 A.M. – 11:30 A.M. 8:00 a.m. - 5:00 p.m. - Regency Foyer, Haymarket, Concourse Level, West Tower Quality Assurance Ballroom Level, West Tower Committee Meeting (Committee Exhibits & Complimentary Coffee Service Members Only) 7:00 a.m. - 4:00 p.m. - Toronto/Hong Kong, 10:00 A.M. – 12:00 P.M. Ballroom Level, West Tower Crystal A, Lobby Level, West Tower Breast Working Group Meeting (Working 7:30 A.M. – 9:30 A.M. Group Members Only) Comiskey, Concourse Level, West Tower Melanoma Working 10:30 A.M. – 12:00 P.M. Group Meeting Gold Coast, Concourse Level, West Tower Bone Marrow & Stem (Working Group Cell Transplantation Members Only) Committee 7:30 A.M. – 9:30 A.M. 11:00 A.M. – 12:00 P.M. Crystal A, Lobby Level, West Tower BARLOGIE-SALMON San Francisco, Ballroom Level, West Tower Publications MYELOMA COMMITTEE Committee 7:30 A.M. – 9:30 A.M. (Committee Members Only) New Orleans, Ballroom Level, West Tower Imaging Committee (Committee Members 11:00 A.M. - 12:00 P.M. Only) Regency Foyer, Ballroom Level, West Tower Plenary Reception

18 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Meetings in all caps CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 receive CME credits Schedule of Events

Order of Levels (top to bottom): Skyway Level | Lobby Level | Concourse Level | Ballroom Level | Riverside Exhibit Level

11:00 A.M. - 12:00 P.M. 4:30 P.M. – 6:30 P.M. Water Tower, Concourse Level, West Tower GI Translational Crystal B, Lobby Level, West Tower GI COMMITTEE Medicine Working Group (Working Group 6:00 P.M. - 7:00 P.M. Members Only) Executive Reception 12:00 P.M. – 2:00 P.M. (Invitation Only) Regency A-C, Ballroom Level, West Tower PLENARY II (GENERAL) 6:45 P.M. – 8:00 P.M. 2:15 P.M. – 3:15 P.M. Regency CD, Ballroom Level, West Tower Reception Gold Coast, Concourse Level, West Tower NCORP/MU-NCORP Site PI Meeting 2:15 P.M. – 4:15 P.M. Saturday, October 14, 2017 Comiskey, Concourse Level, West Tower GI Working Group Group Meeting Registration & Information Desk Meeting (Working Group Members Only) 7:00 a.m. - 5:00 p.m. - Regency Foyer, 2:30 P.M. – 4:00 P.M. Ballroom Level, West Tower San Francisco, Ballroom Level, West Tower VA Working Group Hope Foundation Information Desk (Invitation Only) 8:00 a.m. - 5:00 p.m. - Regency Foyer, 2:30 P.M. – 6:30 P.M. Crystal A, Lobby Level, West Tower GU Organ Site Meeting Ballroom Level, West Tower (Working Group Members Only) 7:15 A.M. – 8:00 A.M. 3:00 P.M. – 5:00 P.M. Regency B, Ballroom Level, West Tower Board of Governors (Board Members Only) New Orleans, Ballroom Level, West Tower ORP Planning Meeting (Committee Members 8:15 A.M. – 9:15 A.M. Only) Regency B, Ballroom Level, West Tower Committee Chairs 4:00 P.M. - 6:00 P.M. (Committee Chairs Only) Crystal C, Lobby Level, West Tower Recruitment and Retention Committee 9:30 A.M. – 11:30 A.M. Meeting Crystal C, Lobby Level, West Tower RADIATION ONCOLOGY 4:00 P.M. - 6:00 P.M. COMMITTEE Water Tower, Concourse Level, West Tower Leukemia Working 9:30 A.M. - 11:30 A.M. Group Meeting Regency C, Ballroom Level, West Tower LEUKEMIA COMMITTEE (Working Group Members Only) 9:30 A.M. – 12:30 P.M. 4:00 P.M. – 6:30 P.M. Regency A, Ballroom Level, West Tower GU COMMITTEE Acapulco, Ballroom Level, West Tower Movie Screening: 9:30 A.M. – 12:30 P.M. Cancer Rebellion Regency D, Ballroom Level, West Tower BREAST COMMITTEE 4:00 P.M. – 7:00 P.M. Regency B, Ballroom Level, West Tower LYMPHOMA COMMITTEE 4:30 P.M. – 6:30 P.M. Columbian, Concourse Level, West Tower Pharmaceutical Sciences Committee

19 SWOG Leading cancer research. Together. ChicagoCHICAGO, Special ILLINOIS | OCTOBER 11-14, 2017 Events

RD All SWOG 3 Annual members are SWOG NCORP Research Base welcome! Clinical Trials Workshop Wednesday, October 11 A training course on clinical trials in cancer care delivery, survivorship, prevention and epidemiology, and symptom 1:00 to 5:00 p.m. control and quality of life

(Check-in l Attendees will gain new knowledge and perspective on at 12:30 p.m.) conducting NCORP studies Regency A+B l Unique presentations by experts from 3 SWOG Statistics and Data Management Center at Fred Attendees Hutchinson Cancer Research Center and Cancer Research And receive up to Biostatistics four hours of 3 The National Cancer Institute’s Division of Cancer credits from Prevention, Healthcare and Delivery Research Program, and the Society of Center to Reduce Cancer Health Disparities, Clinical Research 3 MD Anderson Cancer Center Associates l Breakout discussion sessions on topics specific to practical study (SOCRA) administration

All SWOG Developing Cultural Competency members are welcome, but in Clinical Trials Workshop space is limited An education session designed to enhance the level of and pre- cultural competence of SWOG research members, with the registration is required. goal of increasing diversity among clinical trial participants.

Thursday, PRESENTER: October 12 Marvella Ford, PhD 5:00 to 7:00 p.m. Professor, Department of Public Health Sciences LOCATION TO Associate Director, Population Sciences and COME Cancer Disparities, Hollings Cancer Center SmartState Endowed Chair, Cancer Disparities Research Medical University of South Carolina

Sponsored by the SWOG Recruitment and Retention Committee

SWOG Leading cancer research. Together.

20 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOISBonus | OCTOBER 11-14, 2017 Event! Free Movie Screening Friday, Oct. 13 | 4:00 - 6:30 p.m. Acapulco, Ballroom Level, West Tower Open to All Members Come see Cancer Rebellion, a documentary that chronicles the experience of teen cancer patients from across America . Filmmaker Hernan Barangan, who was treated for acute myelogenous leukemia at 15, logged over 25,000 miles in all 50 states to document teens’ stories Light refreshments will be provided and will speak at the screening . We fund great ideas. You can, too. Because answers to cancers come from clinical trials.

The Hope Foundation is a 501c3 public charity supporting physicians, clinical researchers, scientists, and patient advocates in their pursuit of new and impactful approaches to treating, preventing and detecting cancer, and in bettering the quality of life for both cancer patients and cancer survivors. Please give today: thehopefoundation.org/donate

SWOG.ORG / THEHOPEFOUNDATION.ORG

SUPPORTING THE IMPORTANT WORK OF SWOG

@SWOG/@SUPPORTINGSWOG

LEARN MORE AT THEHOPEFOUNDATION.ORG

21 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

SWOG SWOG Administrative Research Support Committees Committees

Conflict Management Adolescents and Young Adults Paul Okunieff, MD Mark A. Lewis, MD Data and Safety Monitoring Digital Engagement Lawrence E. Flaherty, MD Don S. Dizon, MD Publications Imaging Hagen Kennecke, MD Lawrence H. Schwartz, MD Professional Review Oncology Research Professionals Primo N. Lara, Jr., MD Keisha Humphries, RN, RSN Patient Advocates Rick Bangs, MBA Future Meeting Dates Pharmaceutical Sciences 2018 Co-Chair Siu-Fun Wong, MD April 11-14 Co-Chair Susan Kadlubar, MD San Francisco, CA Radiation Oncology Oct 3-6 Paul Okunieff, MD Chicago, IL Recruitment and Retention 2019 Elise Cook, MD April 24-27 San Francisco, CA Surgery George H. Yoo, MD Oct 2-5 Chicago, IL

2020 April 22-25 San Francisco, CA

Sep 23-26 Chicago, IL

22 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Barlogie-Salmon Myeloma Committee

Leadership Symptomatic Multiple Myeloma (ENDURANCE) ”. Dr . J . Zonder . Activated Chair: ...... Robert Z . Orlowski, M .D ., Ph .D . by ECOG: 11/13/13; Activated by SWOG: 2/1/14 . Vice-Chair: ...... Brian G .M . Durie, M .D . Executive Officer ...... Susan M . O’Brien, M .D . CTSU/A061402, “Solitary Plasmacytoma of Bone: Randomized Phase Statisticians: ...... Antje Hoering, Ph .D . III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and ...... Rachael Sexton, M .S . Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy ”...... Kari Chansky, M .S . Dr . E . Manasanch . Pre-Activated by SWOG: 11/15/2016; Activated by Scientific Leadership Alliance: 12/23/2015 . Translational Medicine: ...... Brian A . Walker, B .Sc ., Ph .D . Closed Studies Radiation: ...... TBD Surgery: ...... J . Sybil Biermann, M .D . S1304, “A Phase II Randomized Study Comparing Two Doses of Carfilzomib Imaging: ...... Saad Z . Usmani, M .D . (NSC-756640) with Dexamethasone for Multiple Myeloma Patients ...... Eric M . Rohren, M .D ., Ph .D . with Relapsed or Refractory Disease ”. Drs . S .A . Ailawadhi, M .H . Abidi, S . Pathology: ...... Robert B . Lorsbach, M .D ., Ph .D . Lentzsch, R .Z . Orlowski, and E . M . Rohren . Activated: 10/18/13 . Closed: Early Therapeutics: ...... Frits van Rhee, M .D ., Ph .D . 5/15/2016 . Designates CTSU/E3A06, “Randomized Phase III Trial of Lenalidomide Versus NCORP Representative: ...... George F . Geils, Jr ., M .D . Observation Alone in Patients with Asymptomatic High-Risk Smoldering Data Coordinators: ...... Jeri Jardine Multiple Myeloma ”. Dr . M . Dhodapkar . Activated by ECOG: 10/5/2010; ...... Laura Kingsbury, M .R T. . Activated by SWOG: 2/1/11 . Closed: 7/27/17 ...... Sean O’Bryan ...... Joanna Dur Proposed Studies Oncology Research Professionals: S1611, “A Phase II Non-Randomized Study of 11-1F4 Chimeric Monoclonal CRA: ...... TBD Ab added to standard treatment in Untreated Subjects with Light Chain Nurses: ...... Deborah A . Shaw, R .N . (AL) Amyloidosis ”. Dr . S . Lentzsch ...... Teresa Witcher, B .S .N ., R .N . Patient Advocate: ...... Jack Aiello, M .S . S1702, “A Phase II Study of Isatuximab (SAR650984) for Patients with Pharmaceutical Science: ...... Lara M . Au, Pharm .D . Previously Treated AL Amyloidosis ”. Dr . E . Scott ...... Craig Elg, Pharm .D . S1803, “Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide Protocol Coordinator: ...... TBD (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Time/Location Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Friday, October 13, 2017 7:30 a .m . - 9:30 a .m . Study) ”. Dr . A . Krishnan . Crystal A, Lobby Level, West Tower XXXXX, “Randomized Phase II Multicenter Non-Inferiority Trial of Active Studies Rivaroxaban 10 mg Daily Versus Low Molecular Weight Heparin for Prevention of Thromboembolism in Patients Being Treated with an S1211, “A Randomized Phase I/II Study of Optimal Induction Therapy Immunomodulatory-Based Regimen for Multiple Myeloma ”. David of Bortezomib, Dexamethasone and Lenalidomide with or without Calverley, Jamie Meyers, and Emma Scott . Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM) ”. Drs . S .Z . Usmani, S . Ailawadhi, and B .Lipe . Activated: Open Forum Discussion 10/12/12 . Temporarily closed to accrual: 6/2/2016 . Working Groups CTSU/E1A11, “Randomized Phase III Trial of Bortezomib, LENalidomide Amyloidosis Working Group update and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Waldenström’s Working Group update Lenalidomide MaintenANCE in Patients with Newly Diagnosed Myeloma Translational Medicine Subcommittee update

23 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Barlogie-Salmon Myeloma Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1211 E1A11 E3A06 Arkansas, U of — 1 — Baylor College — 6 — Beaumont NCORP — 4 — CORA NCORP — 1 — CRC West MI NCORP 1 — — City of Hope Med Ctr 7 — — Cleveland Clinic OH 10 — — Columbus NCORP 4 — — Cookeville Reg MC — 4 — Davis, U of CA — 9 — Dayton NCORP 1 2 — Essentia Hlth NCORP 1 — — Greenville NCORP — — 6 Hawaii MU-NCORP — 1 — Heartland NCORP 3 — — Henry Ford Hosp — 8 1 Irvine, U of CA — 5 1 Kaiser Perm NCORP — 17 — Kansas City NCORP 1 — — Kansas, U of 13 1 15 Loyola University 3 4 — MD Anderson CC 10 — — Michigan CRC NCORP 5 — — Michigan, U of — 1 — Montana NCORP — 3 2 Oklahoma, Univ of 1 — — Oregon Hlth Sci Univ — 3 — Ozarks NCORP 2 6 1 PCRC NCORP — — 1 Providence Hosp 4 5 2 Rochester, Univ of 7 — — San Antonio, U of TX 15 6 — So Calif, U of 2 — — Southeast COR NCORP 4 5 — Sutter Cancer RC — 5 — Tennessee, U of — — 1 Tulane University 1 — 2 VAMC Kansas City — 2 — Wayne State Univ 3 9 — Yale University — 20 3 Alliance 10 — — ECOG-ACRIN 31 — — NRG 3 — — Total 142 128 35

24 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Breast Committee

Leadership Agenda Chair: ...... Lajos Pusztai, M .D . D .Phil . Vice-Chair: ...... Debu Tripathy, M .D . 9:30 – 9:35 a.m.: Welcome and Introductions –Lajos Pusztai, M .D . D .Phil Executive Officer: ...... Julie R . Gralow, M .D . and Debu Tripathy, M .D . Statisticians: ...... William E . Barlow, Ph .D . 9:35 – 10:35 a.m.: Breast Committee Mini-Symposium “The challenge of ...... Danika Lew, M .A . immunotherapy in breast cancer” ...... Jieling Miao, M .S . Scientific Leadership 9:35 – 9:55 a.m.: Biomarkers of response to IO therapy - Sarah Warren, Translational Medicine: ...... Daniel F . Hayes, M .D . M .D . Nanostring Radiation Oncology: ...... Reshma Jagsi, M .D . 9:55 – 10:15 a.m.: The landscape of immunotherapy trials in breast cancer Surgery: ...... Christine Lee, M .D . and current NCTN initiatives- Heather McArthur, M .D . Imaging: ...... Anne F . Schott, M .D . Cedars Sinai Medical Center ...... Wei Tse Yang, M .B .B .S . Pathology: ...... Allen M . Gown, M .D . 10:15 – 10:35 a.m.: SWOG Immunotherapy Trials - Erin Cobain, M .D ...... Peggy L . Porter, M .D . University of Michigan Early Therapeutics: ...... George Somlo, M .D . 10:35 – 10:45 a.m.: Panel discussion and audience Q & A Designates Cancer Control Liaisons: . . . . . Carol J . Fabian, M .D . (Cancer Survivorship) 10:45 – 10:55 a.m.: Publications update - Bill Barlow, Ph .D ...... Dawn L . Hershman, M .D . (Cancer Care Delivery) 10:55 – 11:30 a.m.: Update of open SWOG and CTSU trials - All ...... Banu Arun, M .D . (Prevention) ...... Helen K . Chew, M .D . (Symptom Control & QOL) 11:30 –11:45 a.m.: Studies in Development - All NCORP Representative: ...... Melanie E . Royce, M .D ., Ph .D . 11:45 – 12:00 p.m.: Reports from Committee Liaisons Data Coordinators: ...... Jennie Barrett ...... Jacqueline Scurlock Radiotherapy - Reshma Jagsi, M .D ...... Sean O’Bryan Surgery - Christine Lee, M .D ...... Larry Kaye ...... Iris Syquia Cancer Survivorship - Carol Fabian, M .D . Oncology Research Professionals: Cancer Care Delivery - Dawn Hershman, M .D . CRA: ...... Karyn N . Hart, C C. .R .P . Nurses: ...... Dorothy Coleman, R .N ., M .S . Prevention – Banu Arun, M .D ...... Kathy L . Czaplicki, R .N ., M .S .N . NCORP (NCI Community Oncology Research Program) – ...... Crystal L . Watson, R .N . Melanie Royce, M .D . Patient Advocate: ...... Ginny Mason ...... Elda Railey, R .N ., B .S .N . Patient Advocate – Ginny Mason and Elda Railey Pharmaceutical Science: ...... Jessie Modlin, Pharm .D . 12:00– 12:25 p.m.: Translational Medicine Sub-Cmte – Daniel Hayes, M .D ...... Rivka Siden, Pharm .D . Protocol Coordinator: ...... Veronica Garcia 12:25 – 12:30 p.m.: New Business – All 12:30 p.m.: Closing Comments and Adjourn Time/Location Saturday, October 14, 2017 9:30 a .m . - 12:30 p .m . Active Studies Regency D, Ballroom Level, West Tower S1207, “Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer ”. Drs . Chavez-MacGregor, Rastogi, Pusztai . Activated: 9/3/13 .

25 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Breast Committee

S1416, “Phase II Randomized Placebo-Controlled Trial of Cisplatin with or Active and Developing Cancer Control Studies without ABT-888 (Veliparib) in Metastatic Triple Negative Breast Cancer S1415CD, “A Pragmatic Trial to Evaluate a Guideline Based Colony (TNBC) and BRCA Mutation-Associated Breast Cancer ”. Drs . Rodler and Stimulating Factor Standing Order Intervention and to Determine the Sharma . Activated: 7/7/16 . Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients S1418, “A Randomized Phase III Trial to Evaluate the Efficacy and Safety Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor- – Trial Assessing CSF Prescribing Effectiveness and Risk (TRACER)” . Drs . Negative Breast Cancer with ≥1 cm Residual Invasive Cancer or Positive Ramsey, Hershman, Lyman and Sullivan . Activated: 10/7/16 . Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy ”. Drs . Pusztai S1501, “Prospective Evaluation of Carvedilol vs No Treatment in Prevention and Mammen . Activated: 11/15/16 . of Cardiac Dysfunction in Women with Metastatic HER2+ Breast Cancer ”. CTSU/A011106, “Alternate Approaches for Clinical Stage II or III Estrogen Drs . Floyd and Leja . Activation: 9/15/17 . Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in CTSU/A011401, “Randomized Phase III Trial Evaluating the Role of Weight Postmenopausal Women: A Phase III Study ”. Dr . Ma . SWOG Champion: Dr . Loss In Adjuvant Treatment of Overweight and Obese Women with Early Forero . Activated: 12/13/13 . Breast Cancer ”. Drs . Ligibel and Hershman . Activated: 8/29/16 . CTSU/A011202, “A Randomized Phase III Trial Comparing Axillary Lymph CTSU/E1Z11, “A Cohort Study to Evaluate Genetic Predictors for Aromatase Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 Inhibitor Musculoskeletal Symptoms (AIMSS) ”. Dr . Stearns . Activated: N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant 5/21/13 . Chemotherapy ”. Dr . Boughey . SWOG Champion: Dr . Mammen . Activated: 2/7/14 . Closed Studies

CTSU/A011502, “A Randomized Phase III Double Blinded Placebo S1007, “A Phase III, Randomized Clinical Trial of Standard Adjuvant Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Negative Breast Cancer: The ABC Trial ”. Dr . Chen . SWOG Champion: Dr . Nodes, Hormone-Receptor-Positive and HER2-Negative Breast Cancer Symington . Activated: 12/8/16 . with Recurrence Score (RS) of 25 or Less . RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer ”. Drs . Kalinsky, CTSU/EA1131, “A Randomized Phase III Post-Operative Trial of Platinum Gralow, Meric-Bernstam, Hortobagyi, Albain and Barlow . Activated: Based Chemotherapy vs . Capecitabine in Patients with Residual 1/15/11 . Closed: 10/1/15 . Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy ”. Dr . Mayer . SWOG Champion: Dr . Rodler . Activated CTSU/A011203, “A Randomized Phase II Trial of Tamoxifen Versus 4/29/15 . Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer ”. Dr . Goetz . Activated: CTSU/E2112, “A Randomized Phase III Trial of Endocrine Therapy plus 3/6/15 . Closed: 5/19/17 Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer ”. Dr . Connolly . SWOG Champion: Dr . Royce . CTSU/E4112, “Prospective Study of Magnetic Resonance Imaging (MRI) Activated: 3/29/14 . and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS) ”. Drs . Leman, Khan and So . Activated: 2/17/15 . Closed: 4/20/16 CTSU/NRG-BR002, “A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation CTSU/Z11102, “Impact of Breast Conservation Surgery on Surgical for Newly Oligometastatic Breast Cancer ”. Drs . Chmura and White . SWOG Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast Champion: Dr . Jagsi . Activated: 12/24/14 . Cancers (MIBC) ”. Dr . Boughey . Activated: 7/23/12 . Closed: 8/19/16 .

CTSU/NRG-BR003, “A Randomized Phase III Trial of Adjuvant Therapy Closed Cancer Control Studies Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly S1200, “Randomized Blinded Sham- and Waitlist-Controlled Trial of Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Node-Negative Triple-Negative Invasive Breast Cancer ”. Dr . Valero . SWOG Women with Early Stage Breast Cancer ”. Drs . Hershman and Crew . Champion: Dr . Makhoul . Activated: 6/26/15 . Activated: 3/27/12 . Closed 2/15/17 .

26 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Breast Committee

S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus GO MOBILE AT THE MEETING (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients ”. Drs . Ramsey, Loomba, Chugh, Hershman and Hwang . We’re excited to announce we have a brand new mobile Activated: 8/29/13 . Closed: 2/15/17 . guide for you to use on Guidebook! Get the guide to Rare Cancers Active Studies access the most up-to-date information about our event, including schedules, maps, and much more. S1609, “DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors ”. Drs . Patel and Chae . Activated 1/13/17 . Get our guide here: https://guidebook.com/g/swogfall2017 CTSU/EAY131, “Molecular Analysis for Therapy Choice (MATCH) ”. Drs . Android and iOS users: Chen and Flaherty . Activated: 8/12/15 . 1. Tap the “Download” Studies in Development button to download the S1706, “A Phase II Randomized, Double-Blinded, Placebo-Controlled free Guidebook app Trial of Olaparib Administered Concurrently with Radiotherapy for 2. Open Guidebook Inflammatory Breast Cancer ”. Dr . Jagsi . and you can find our “SWOG Fall 2017 S1719, “PeRsistently Elevated CTCs in Chemotherapy Refractory Group Meeting” guide Metastatic Breast Cancer Treated with Combination Immune CHEcKpoint Inhibition (PRE-CHEK) ”. Drs . Cobain and Hayes . See you there! Phase II Randomized Trial to Evaluate the Safety and Efficacy of — SWOG Spring 2017 Pertuzumab and Trastuzumab Plus Ribociclib and an Aromatase Group Meeting Inhibitor or Fulvestrant as Therapy for HER2-positive and HR-positive Team Metastatic Breast Cancer (PETRA) . Drs . Giordano and Lu .

Single Arm Treatment De-escalation Trial for Clinical Stage I-IIIA, HER-2 Positive, Invasive Breast Cancer that Achieved Pathologic Complete Response (ypT0/is ypN0) After Neoadjuvant Chemotherapy and HER-2- Targeted Therapy . Drs . Sanft and Elias . COMPATIBLE WITH iPHONES, iPADS , ANDROID AND BLACKBERRY DEVICES

More than $300,000 To VA Medical Centers Since 2015 To Improve Veterans' Access to National Clinical Trials Network Cancer Clinical Trials

SWOG Leading cancer research. Together.

27 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Breast Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1007 S1207 S1416 S1418 A011106 A011202 A011203 A011401 A011502 A221405 B51 B52 B55 E1Z11 E2112 E4112 EA1131 NRGBR003 Z11102 Arizona MC, U of — 9 — — 15 1 — — — — — — — — — — — — — Arkansas, U of 22 15 — 2 — — — 1 — — — — — — — — — — — Atlanta Reg CCOP 11 — — — — — — — — — — — — — — — — — — Baptist MU-NCORP 1 4 1 — 9 1 1 1 — — — — — 1 1 — — 1 — Bay Area NCORP 3 1 — 1 — — — — — — — — — — — — — — — Baylor Univ Med Ctr — 2 — — — — — — — — — — — — — — — — — Beaumont NCORP 30 7 1 — — — — — — — — — — 3 — — — — 1 Boston Medical Ctr — 1 — — — — — — — — — — — — — — — — — Brooke Army Med Ctr 2 — — 1 — — — — — — — — 1 — — — 2 — — CORA NCORP 16 12 — 3 1 — — — — — 2 — — 1 3 — — — — CRC West MI NCORP 7 6 2 2 — — — 1 — — — — — 2 — — — — — Carle CC NCORP — 2 — — — — — — — — — — — — — — — — — Cedars-Sinai Med Ctr 8 9 — — — — — — — — — 3 5 — — — — — — Cincinnati MC, U of 3 8 — — — — — — — — — 1 — 4 — — — — — City of Hope Med Ctr 45 16 — — — — — — — — — — — — — — — — — Cleveland Clinic OH 27 12 — — — — — — — — — — 1 — 11 — — 5 — Colorado, U of 29 11 — — 4 22 — 6 2 1 1 — 1 2 — — — — 6 Columbia MU-NCORP 16 4 — — — — — — — — — 1 — 16 2 — — — — Columbia University 2 — — — — — — — — — — — — — — — — — — Columbus NCORP 18 13 5 2 — — — — — — — — — 2 — — — — — Cookeville Reg MC 7 — — — — — — — 1 — — — — — — — — — — Davis, U of CA 8 7 5 1 — — — — 2 — — — — 1 — — — — — Dayton NCORP 6 5 4 — 2 — — 1 — — — — — 2 — — — — — Desert Hospital 2 1 — — — 2 — — — — 3 — — — — — — — — Essentia Hlth NCORP — 1 — — — — — — — — — — — — — — — — — Fred Hutchinson CRC 6 18 5 1 — — — 1 — 1 — — 1 — 1 — — — — Georgia NCORP — 1 — 1 — — — — — — — — — 8 — — — — — Greenville NCORP 4 — 2 — — — — — — — — — — 12 — — — — — Gulf Coast MBCCOP 2 — — — — — — — — — — — — — — — — — — Gulf South MU-NCORP 6 15 — — — — — — — — — — — 5 — — — 1 — H Lee Moffitt CC 2 5 — — — 1 — — 2 — — — — — — 11 — — — Harrington CC 2 1 — — — 3 — — — — — — — — — — — — — Harrison Medical Ctr 9 — — — — — — — — — — — — — — — — — — Hawaii MU-NCORP 12 8 — — — — — — — — — — — 16 — — — — — Heartland NCORP 12 15 3 1 — — — — — — — — — — — — — — — Henry Ford Hosp 11 4 — — — — — — — — — — — — 1 — — — — INC, Bogota 11 — — — — — — — — — — — — — — — — — — INCan 96 — — — — — — — — — — — — — — — — — — Intermountain MC 5 — — — — — — — — — — — — — — — — — — Irvine, U of CA 21 8 — — 2 — — 2 — — — — — — — — — — — Kaiser Perm NCORP 89 33 — — — 1 2 11 — — — — 2 28 — 1 — 4 — Kansas City NCORP 11 6 — — — — — — — — — — — — — — — — — Kansas, U of 33 37 — 2 — 4 — 5 — — — 1 1 — 7 — — — — Kentucky, U of 21 — — — — — — — — — — — — — — — — — — King Faisal Spec Ho 3 — — — — — — — — — — — — — — — — — — Lahey Hosp & Med Ctr 19 4 — — — — — — — — — — — — — — — — —

28 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Breast Committee, cont. Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1007 S1207 S1416 S1418 A011106 A011202 A011203 A011401 A011502 A221405 B51 B52 B55 E1Z11 E2112 E4112 EA1131 NRGBR003 Z11102

Loma Linda Univ 5 7 — — — 2 — — — — 2 1 — — — — — — — Loyola University 30 11 1 — — — — 3 — — 1 1 — — — — — — — MD Anderson CC 147 55 — — — — — — — — — — — — — — — — — MUSC MU-NCORP 21 8 4 — 1 — — — — — — — — 5 — — — — — Madigan Army Med Ctr 3 — — — — — — — — — — — — — — — — — — Methodist Hospital 7 — — — — — — — — — — — — — — — — — 3 Michigan CRC NCORP 44 17 4 1 — — — — — — — — — — — — — — — Michigan, U of 29 16 2 — — — — 2 — — — — 1 11 — — — 3 — Mississippi, Univ of 4 — — — — — — — — — — — — — — — — — — Montana NCORP 9 6 — — — — — — — — — — — 4 — — — — — National Cancer Ctr 143 — — — — — — — — — — — — — — — — — — Nevada CRF NCORP 1 1 — — — — — — — — — — — — — — — — — New Mexico MU-NCORP 27 17 5 — 1 — — — — — — — — — — — — — — Northwest NCORP 28 3 — — — — — — — — — — 1 — — — — — — Northwestern Univ 3 8 — — — — 4 — — — — — — — 2 — — 1 — Oklahoma, Univ of 8 9 — — — — — — — — — — — — — — — — — Orange Reg Med Ctr — — — 2 — — — — — — — 1 — — — — — — — Oregon Hlth Sci Univ 4 17 2 — — — — — — — 1 — — — — — — — — Ozarks NCORP 9 12 2 — — — — — — — — — — 9 — — — 3 — PCRC NCORP 31 14 — 2 — — — 1 — — — — — 6 — — — 1 — Providence Hosp 8 7 — 1 — 2 — 2 — — 2 — 1 2 — — — 3 — Rochester, Univ of 7 4 — — — — — — — — — — — — — — — 2 — San Antonio, U of TX 25 19 — — 1 — — — — — — — 1 — 4 — — 3 — San Diego, U of CA 9 — — — — — — — — — — — — — — — — — 1 So Calif, U of 15 8 — — — 2 — — — — — — — — — — — — — Southeast COR NCORP 31 21 4 3 — — — — — — — — — — — 1 — — — St Louis CCOP 3 — — — — — — — — — — — — — — — — — — St Louis University 1 1 — — 1 — — — — — — — — — — — — — — Sutter Cancer RC — 9 1 — 4 — — 1 — — 1 — — — — — — 2 — Tennessee, U of 5 5 — — — 4 — — — — 3 — — — — — — — — Tulane Univ MBCCOP 3 — — — — — — — — — — — — — — — — — — Tulane University 6 — — — — — — — — — — — — — — — — — — Univ of Louisville 8 — — — — — — — — — — — — — — — — — — Upstate Carolina 3 — — — — — — — — — — — — — — — — — — Utah, U of 18 — 2 — — — — — — — — — — — — — — — — Wayne State Univ 23 11 — — — 6 — — — — — — 2 — 3 — — 5 3 Wichita NCORP 57 27 2 3 — — — — — — — — — — — — — — — Wisconsin NCORP — 1 1 — — — — — — — — — — — — — — — — Yale University 24 32 — — — — — 21 1 — — — — 2 1 7 2 4 — Alliance 526 203 20 2 — — — — — — — — — — — — — — — CCTG 328 — — — — — — — — — — — — — — — — — — ECOG-ACRIN 713 193 12 2 — — — — — — — — — — — — — — — GEICAM 792 — — — — — — — — — — — — — — — — — — NRG 265 251 21 9 — — — — — — — — — — — — — — — UNICANCER 921 — — — — — — — — — — — — — — — — — — Total 4,982 1,294 112 42 41 51 7 59 8 2 16 9 18 142 36 20 4 38 14

29 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Cancer Control and Prevention Committees

Leadership Designates Vice-Chair NCORP: ...... Dawn L . Hershman, M .D ., M .S . Oncology Research Professionals Cancer Care Delivery Cmte Co-Chairs: . . . Dawn L . Hershman, M .D ., M .S . Clinical Research Associates: . . . . . Amanda R . Dinsdale, M .H .A ., C C. .R C...... Scott D . Ramsey, M .D ., Ph .D ...... Connie Szczepanek, R .N . Cancer Survivorship Cmte Co-Chairs: . . . . Robert S . Krouse, M .D ., F .A C. .S ...... Mindy Whisnant, C C. .R .P ...... TBD Nurses: ...... Joan Long, R .N . Prevention and Epidemiology Cmte Co-Chairs: ...... Banu Arun, M .D ...... Michaela S . Sherbeck, R .N ...... Marian Neuhouser, Ph .D ., R .D ...... Joyce N . Tull, R .N . Symptom Control & QOL Cmte Co-Chairs: . . . . Michael Fisch, M .D ., Ph .D . Pharmaceutical Sciences Committee: ...... Manj Randhawa, Pharm .D ...... Norah Lynn Henry, M .D ., Ph .D ...... Siu-Fun Wong, Pharm .D . Executive Officers: . . . . Katherine D . Crew, M .D . (Prevention, Survivorship) ...... Susan A . Kadlubar, Ph .D ...... Gary Lyman, M .D (CCD,. Symptom Control & QOL) SDMC Data Coordinators and Staff: ...... Heidi Dong Senior Advisor: ...... Frank L . Meyskens, Jr ., M .D ...... Sam Dzingle Statisticians: ...... Garnet Anderson, Ph .D ...... Diane Liggett, C C. .R .P ...... William E . Barlow, Ph .D ...... Jennifer Patterson ...... Katherine Guthrie, Ph .D ...... Roxanne. Topacio, C C. .R .P ...... Cathy Tangen, Dr .P .H ...... Monica Yee, C C. .R .P ...... Joseph M . Unger, Ph .D . SDMC Recruitment and Retention Specialist: . . . . Jennifer Maeser, M .S ...... Riha Vaidya, Ph .D . Patient Advocates: ...... Barbara Segarra-Vazquez, D .H .Sc . (CCD) ...... Kathryn B . Arnold, M .S ...... Amy. Geschwender, Ph .D . (Symptom Control & QOL) ...... Amy K . Darke, M .S ...... Hartley “Lee” M . Jones, M .B .A . (Survivorship) ...... Phyllis J . Goodman, M .S ...... Sandra Jean Hamilton, R .N ., M .E .D . (Recruitment & Retention) ...... Danika Lew, M .A ...... Cheryl Jernigan, CPA (Prevention & Epidemiology) ...... Edward Mayerson, M .S . Protocol Coordinator (Cancer Care Delivery; ...... Anna Moseley, M .S . Prevention and Epidemiology Committees): ...... Patricia O’Kane ...... Cathee. Till, M .S . Protocol Coordinator (Cancer Survivorship Administrative Lead Statistics & Data Management: . Monica Yee, C C. .R .P . Committee): ...... Nicki Trevino Scientific Leadership Protocol Coordinator (Symptom Control and NCORP Representative: ...... Mark A . O’Rourke, M .D . Quality of Life Committee): ...... Dawne Wenzel, M .A ., M .S . Radiation Oncology Committee: ...... Louis “Sandy” Constine, M .D . Surgery Committee: ...... Robert S . Krouse, M .D .FACS Translational Medicine: ...... James (Jimmy) Rae, Ph .D . Liaisons: Breast Committee: ...... TBD (Survivorship) ...... Norah Lynn Henry, M .D ., Ph .D (Symptom. Control & QOL) ...... Dawn. Hershman, M .D, M .S . (CCD) ...... Banu Arun, M .D . (Prevention) CCDR Committee: ...... Afsaneh Barzi, M .D . (GI) Gastrointestinal Committee Colon: ...... Jason, Zell, D O. . (Prevention) Genitourinary Committee: ...... Peter J . Van Veldhuizen, Jr ., M .D . International Liaison: ...... Kathy S . Albain, M .D . Lung Committee: ...... Gary E . Goodman, M .D . Melanoma Committee: ...... Sancy Leachman, M .D ., Ph .D . Recruitment and Retention Committee: ...... Elise Cook, M .D .

30 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Cancer Control and Prevention Committees

Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0820 A211102 A211201 EA1141 Baptist MU-NCORP 1 — — — Brooke Army Med Ctr 2 — — — CORA NCORP 2 — — — City of Hope Med Ctr 1 2 — — Colorado, U of 2 — — — Columbia MU-NCORP 1 1 2 — Columbus NCORP 3 — — — Dayton NCORP 1 — — — Essentia Hlth NCORP 3 — — — Georgia NCORP 2 — — — Hawaii MU-NCORP 6 — — — Heartland NCORP 2 — — — Irvine, U of CA 15 — — — Kaiser Perm NCORP 21 — 9 — Kansas, U of 3 — — — Lahey Hosp & Med Ctr — — 1 7 Loma Linda Univ 1 — — — Loyola University 1 — — — MAVERIC 3 — — — MD Anderson CC 8 — — — Michigan CRC NCORP 4 — — — Michigan, U of — — 2 — Mississippi, Univ of 1 — — — Northwest NCORP 3 — — — Oklahoma, Univ of 1 — — — Providence Hosp 1 — — — San Antonio, U of TX 6 — — — So Calif, U of 4 1 — — Southeast COR NCORP 1 — — — Wayne State Univ 2 — — — Wichita NCORP 10 — — — Yale University 7 — — — Alliance 14 — — — ECOG-ACRIN 9 — — — NRG 14 — — — Total 155 3 14 7

31 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Cancer Care Delivery Committee

Leadership Ancillary Study to Evaluate Patient & Physician Knowledge, Attitudes, and Co-Chairs: ...... Dawn L . Hershman, M .D ., M .S . Preferences Related to Return of Genomic Results in SWOG 1400 (Lung- ...... Scott D . Ramsey, M .D ., Ph .D . MAP) . Josh Roth, Ph .D ., MHA, Fred Hutchinson; Meghna Trivedi, M .D ., Columbia University Time/Location Thursday, October 12, 2017 10:15 a .m . -12:15 p .m . Active Studies Regency D, Ballroom Level, West Tower S1415CD, “A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Presentations/Concepts: Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients “How and when should we address value, access, and costs in the oncology Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia clinic?” Jeffrey Peppercorn, M .D ., MPH Associate Professor of Medicine, - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER) ”. Drs . Massachusetts General Hospital, Harvard Medical School S .D . Ramsey, D .L . Hershman, G .H . Lyman, S .D . Sullivan, A . Bansal and W . Barlow . Activated: 10/7/16 . “Randomized Trial of a Proactive Financial Navigation Intervention for Cancer Patients and Caregivers ”. Veena Shankaran, M .D ., University of S1417CD, “Implementation of a Prospective Financial Impact Assessment Washington Tool in Patients with Metastatic Colorectal Cancer ”. Dr . Shankaran . Activated: 4/15/16 . Protocols in Development Updates on Closed Studies S1703, “Randomized Non-inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Screening for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) Hormone Receptor Positive Breast Cancer ”. Melissa Accordino, M .D ., and Hepatitis C (HCV) Among Newly Diagnosed Cancer Patients ”. Drs . Columbia University Ramsey, Loomba, Chugh, Hershman, and Hwang . Activated: 8/29/13 . Closed: 2/15/17 . Concepts Approved by Triage Substudies (Economic Analyses / Cost Effectiveness from S1705, “Post Marketing Utilization and Effectiveness of Nivolumab and NCTN trials) Palbociclib in General Population ”. Afsaneh Barzi, M .D ., University of Southern California; Alan Lyss, M .D ., BJC S1007, Update on Quality of Life and Economic Analysis Sub-study of Breast protocol S1007 . Bill Barlow, Ph .D . Concepts in Development S1207, Cost Effectiveness Analysis of “Phase III Randomized, Placebo- Breast Cancer Endocrine Therapy Adherence Text Messaging Study (“BETA- controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Text”) . Sarah Mougalian, M .D ., Yale University (Primary committee is Therapy +/- One Year of Everolimus in Patients with High-risk, Hormone Symptom Control/QOL) Receptor-positive and HER2 Negative Breast Cancer ”. Dr . Chavez- Health Insurance Coverage as a Potential Barrier to Enrollment in Cancer MacGregor . Clinical Trials . Josh Roth, Ph .D ., MHA, Fred Hutchinson SEED Funded Pilot Trial

Drug Interaction Screening Tool for Clinical Trial Enrollment . Dan Hertz, A Pilot Project to Identify Techniques to Raise Awareness about SWOG Pharm . D ., Ph .D ., University of Michigan College of Pharmacy Clinical Trials on an Online Oncologist Q&A Network . Nadine Housri, M .D . Optimizing Clinical Work Intensity Among Medical Oncologists . Matthew Hudson, Ph .D ., MPH, Greenville Health System

32 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Cancer Care Delivery Committee

Closed Studies PCORI Project: A Structured Approach to Prioritizing Cancer Research Cancer Care Delivery Committee Using Stakeholders and Value of Information (VOI) . Dr . Ramsey and Cumulative Accrual by Institution and Study Dr . J . Carlson . For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016. Newly Funded And Ongoing Database/Grant Funded Projects S1204 S1415CD S1417CD A011104 Long-term Consequences of Intervention Following Receipt of Baptist MU-NCORP — 27 — — Finasteride or Placebo in the Prostate Cancer Prevention Trial . Bay Area NCORP 92 7 — — Joseph Unger, Ph .D . Boston MC MBCCOP 33 — — — Boston Medical Ctr 69 — — — Newly Funded Database Studies Brooke Army Med Ctr — — — 2 CORA NCORP — 8 2 — Development of Prognostic Risk Models for Response to Treatment CRC West MI NCORP — 2 7 — and Placebo for Aromatase Inhibitor-Associated Musculoskeletal Carle CC NCORP — 22 — — Columbia MUNCORP 266 33 9 — Symptoms . Lynn Henry, M .D ., Ph .D . Columbus NCORP — 4 9 — Cookeville Reg MC — — — 2 Secondary Data Analysis of Adolescent & Young Adult Oncology (AYA) Dayton NCORP — 2 2 — Patients in Relation Desert Hospital 77 — — — Essentia Hlth NCORP — 14 — — to their Body Mass Index (BMI) and Cancer Outcomes . Georgia NCORP — 5 3 — Mark Lewis, M .D . Greenville NCORP 542 35 8 — Gulf South MUNCORP 426 11 — — Ongoing Database Pilot Studies Harrington CC 147 — — — Hawaii MUNCORP 86 14 2 — Ethnic disparities among participants in SWOG randomized clinical Heartland NCORP — 116 9 — trials . Mariana Chavez, M .D . (Manuscript submitted) Kaiser Perm NCORP 624 — 5 — Loyola University 74 — — — Osteoporosis in Patients with Colorectal Cancer Enrolled on SWOG MD Anderson CC 354 — — — Trials . Afsaneh Barzi, M .D . (Manuscript submitted) Michigan CRC NCORP — 9 3 — Montana NCORP 33 13 1 — Evaluating the role of geographic location on outcomes among New Mexico MU-NCORP — 25 2 — patients enrolled in SWOG trials . Banu Symington, M .D . (Manuscript Northwest NCORP — 10 — — Ozarks NCORP — 72 — — in preparation) PCRC NCORP 6 65 1 — Providence Hosp — — — 4 San Antonio, U of TX 146 — — — Southeast COR NCORP — 69 5 — Sutter Cancer RC 10 — — — VAMC Kansas City 107 — — — Wayne State Univ — — — 1 Wichita NCORP — 40 2 — Wisconsin NCORP — 4 — — Alliance — 52 1 — ECOG-ACRIN — — 7 — NRG — 3 1 — Total 3,092 662 79 9

33 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Cancer Survivorship Committee

Leadership Co-Chairs: ...... Robert S . Krouse, M .D ...... TBD Cancer Survivorship Committee Cumulative Accrual by Institution and Study Time/Location For the Period Ending July 30, 2017 | Includes studies that are Thursday, October 12, 2017 8:00 a .m . - 10:00 a .m . currently open, or that closed since Jan. 1, 2016 Regency D, Ballroom Level, West Tower S1316X0000 E1Q11 Arizona MC, U of 8 — Plenary Arkansas, U of 5 — Baylor College 1 — “Radiation therapy: Still a double-edged sword but trying to dull the City of Hope Med Ctr 4 — normal tissue edge ”. Louis Constine, M .D . Columbia MU-NCORP 1 — Hawaii MU-NCORP — 4 Advocate Update: Rick Bangs Kansas, U of 12 — MD Anderson CC 1 — Introduction of new Cancer Survivorship Advocate – Lee Jones MUSC MU-NCORP 5 — Michigan, U of 7 — Approved Studies Oklahoma, Univ of 2 — S1501, “Prospective Evaluation of Carvedilol in Prevention of Cardiac Tennessee, U of 14 — Alliance 7 — Toxicity in Patients with Metastatic HER-2+ Breast Cancer ”. Justin Floyd, NRG 25 — D O. . and Monika Leja, M .D . Total 92 4 Update of Concepts Previously Proposed

S1713, “Text Intervention to Improve Cardiovascular Health In Breast Cancer Subcommittee Updates Survivors ”. Dawn Hershman, M .D . Sarcoma Survivorship: Lara Davis, M .D . and Laurence H . Baker, D O. .

A fractional factorial trial to identify the most effective method to increase New concept: Physical function in sarcoma survivors . Lara Davis, M .D ., Kerri physical activity among colorectal cancer survivors . Heather Greenlee, Winters-Stone, Ph .D ., FACSM, Kim Templeton, M .D . N .D ., Ph .D . GU Survivorship: Peter Van Veldhuizen, M .D . A Phase II trial of flibanserin to improve desire in women with cancer . Don Dizon, M .D . New concept: Testosterone replacement and exercise in hypogonadal prostate cancer survivors . Tanya Dorff, M .D . A Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors . Virginia Sun, Ph .D ., R .N . Cardiovascular toxicity in renal cell carcinoma . Kerryn Reding, Ph .D ., M .P .H ., R .N . Weight Loss in Newly Diagnosed Prostate Cancer . Jill Hamilton-Reeves, Ph .D ., R .D . Palliative Medicine: Frank L . Meyskens, M .D .

Activate Studies Cancer Survivorship Website Project: Mark O’Rourke, M .D ., Jennifer Klemp, Ph .D ., and Marian Neuhouser, Ph .D ., R .D . S1316, “Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction ”. Robert Krouse, M .D . Activated: 3/9/15 . Oncology Research Professionals Update: Jamie Myers APRN, Ph .D . Other Business

34 XXX SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Prevention & Epidemiology Committee

Leadership New Business Co-Chairs: ...... Marian Neuhouser, Ph .D ., R .D ...... Banu Arun, M .D . Concepts approved by Triage S1711, “Decision Support to Increase Chemoprevention Uptake Among Time/Location Women with Atypical Hyperplasia or Lobular Carcinoma In Situ ”. Dr . Thursday, October 12, 2017 12:30 p .m . - 2:30 p .m . Katherine Crew, M .D ., M .S . Regency D, Ballroom Level, West Tower Concepts Approved By NCORP Executive Committee: Presentations A Randomized Study of Aspirin in Addition to Non-Steroidal Al in Obese Welcome and Opening Comments: Marian Neuhouser and Banu Arun Subjects with Breast Cancer . Andrew Brenner, M .D ., Ph .D .

Breast Density: Opportunities and Implications for Breast Cancer Prevention Phase II Study of Intraoperative Radiotherapy (IORT) for DCIS after Breast Gretchen Gierach, Ph .D ., MPH, National Cancer Institute Conserving Surgery . Eileen Connolly, M .D .

Active Studies Biology-Based Care in Testicular Cancer . Craig Nichols, M .D .

S0820, “A Double-Blind Placebo-Controlled Trial of Eflornithine and Exploratory Study to Evaluate Mammographic Density Changes in Patients Sulindac to Prevent Recurrence of High Risk Adenomas and Second Receiving Pembrolizumab in S1418 . Banu Arun, MD Primary Colorectal Cancers in Patients With Stage 0-III Colon or Rectal Assessment of Microbiota Composition Among Patients from SWOG S1119 . Cancer, Phase III ”. Drs . Zell, Brown, Lance, Krouse and Lipkin . Activated: C Xi, MD 3/1/13 . Concepts in Development NHLBI-MDS, The National Myelodysplastic Syndromes Natural History Study . Deirdre Hill, MPH, PhD, Study Champion . Project STOP (SWOG Tobacco program for Oncology Practice) . Irene Tami- Maury, DMD, MSc, DrPH Closed Studies Bazedoxefine + Conjugated Estrogen for Cancer Prevention in Women with S0812, “A Randomized Double-Blind Placebo-Controlled Biomarker Hot Flashes . Carol Fabian, MD and Lauren Nye, MD . Modulation Study of High Dose Vitamin D in Premenopausal Women at High Risk for Breast Cancer, Phase IIB ”. Dr Crew . Activated 11/1/11; Closed Melanoma Chemoprevention . Sancy Leachman, MD . 8/15/14 . Other Concepts to discuss

Open discussion

SWOG FACTS The Hope Foundation is SWOG’s philanthropic arm, a non- profit public charity dedicated to raising funds to support SWOG’s mission . It has contributed $30 million to the group for research, travel, and training and education . Though SWOG originated in the southwestern U.S., it has long since become a national -- even international -- organization . Its core bases of operation are spread across the country, with key offices in Oregon, Texas, Washington, and Michigan . SWOG’s Biorepository holds more than 800,000 specimens with associated clinical data .

LEARN MORE AT THEHOPEFOUNDATION.ORG

35 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Prevention & Save the date for Epidemiology Committee Cumulative Accrual by Institution and Study the spring meeting For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016. April 11-14 S0820 A211102 A211201 A211201 San Francisco, CA Baptist MU-NCORP 1 — — — Brooke Army Med Ctr 2 — — — CORA NCORP 2 — — — City of Hope Med Ctr 1 2 — — Colorado, U of 2 — — — Columbia MU-NCORP 1 1 2 — Columbus NCORP 3 — — — Dayton NCORP 1 — — — Essentia Hlth NCORP 3 — — — Georgia NCORP 2 — — — Hawaii MU-NCORP 6 — — — Heartland NCORP 2 — — — Irvine, U of CA 15 — — — Kaiser Perm NCORP 21 — 9 — Kansas, U of 3 — — — Lahey Hosp & Med Ctr — — 1 7 Loma Linda Univ 1 — — — Loyola University 1 — — — MAVERIC 3 — — — MD Anderson CC 8 — — — Michigan CRC NCORP 4 — — — Michigan, U of — — 2 — Mississippi, Univ of 1 — — — Northwest NCORP 3 — — — Oklahoma, Univ of 1 — — — Providence Hosp 1 — — — San Antonio, U of TX 6 — — — So Calif, U of 4 — — — Southeast COR NCORP 1 — — — Wayne State Univ 2 — — — Wichita NCORP 10 — — — Yale University 7 — — — Alliance 14 — — — ECOG-ACRIN 9 — — — NRG 14 — — — Total 155 3 14 7

36 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Symptom Control & Quality of Life Committee

Leadership S1007, “A Phase III, Randomized Clinical Trial of Standard Adjuvant Co-Chairs: ...... Norah Lynn Henry, M .D ., Ph .D . Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive ...... Michael J . Fisch, M .D ., M .P .H . Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or less . RxPONDER: A Clinical Trial Rx Time/Location for Positive Node, Endocrine Responsive Breast Cancer ”. Drs . Kalinski and Friday, October 13, 2017 7:30 a .m . - 9:30 a .m . Gralow . Closed to accrual 10/1/15 . Quality of Life and Economic Substudy Regency D, Ballroom Level, West Tower closed to accrual 12/1/12 .

Feature Presentations (60 minutes) S1202, “Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor- Associated Musculoskeletal Symptoms in Women with Early Stage Breast Lynn Henry, M .D .: Exploring placebo effects in symptom management Cancer ”. Drs . Henry and Schott . Activated: 5/15/13 . Closed to accrual trials in SWOG 10/1/15 . Lynne Nguyen, MPH: Plain talk about patient communications Other Concepts in Development Trials under development (30 minutes) “The Breast Endocrine Toxicity and Adherence (BETA) Trial ”. Sarah “A Phase II randomized, placebo-controlled study to evaluate the use of Mougalian, M .D . vitamin K1 topical cream in patients with cutaneous toxicity caused by S1714, “A prospective observational cohort study to assess the incidence of EGFR inhibitors ”. Dr . Wong . chemotherapy-related peripheral neuropathy ”. Meghna Trivedi, M .D . “Cognitive Rehabilitation Intervention during Cancer Treatment: Emerging “Cognitive Rehabilitation Intervention during Cancer Treatment: Emerging from the Haze ”. Jamie Myers, Ph .D ., R .N ., AOCNS and Dr . Asher, M .D . from the Haze ”. Arash Asher, M .D .; Jamie Myers, Ph .D ., RN, AOCNS . Other Discussion Topics (30 minutes) “A Phase II Randomized Placebo-Controlled Study to Evaluate the Use of Michael Fisch: Palliative care update vitamin K1 Topical Lotion in Patients with Cutaneous Toxicity Caused by Epidermal Growth Factor Receptor (HER1/EGFR) Inhibitors ”. Drs . Wong, Other topics (TBD) Ryan, Wade, & Moinpour . Approved Trials (not yet active) Other Studies with Symptom Control and QOL Component S1600, “Effect of Immune-Enhancing Nutrition on Radical Cystectomy S1418, “A Randomized Phase III Trial to Evaluate the Efficacy and Safety Outcomes ”. Jill Hamilton-Reeves, Ph,D . of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor- S1614, “Randomized Trial of Prophylactic Antiviral Therapy in Patients with Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Current or Past Hepatitis B Virus (HBV) Infection Receiving Cytotoxic Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy ”. Drs . Pusztai Therapy for Solid Tumors ”. Jessica Hwang, M .D ., MPH . and Mammen . Activated: 11/15/16 .

Closed Studies S1207, “Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating S1013, “A Phase II Prospective Study of Epidermal Growth Factor Receptor the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Functional Assessment of Cancer Therapy – EGFRI 18 (FACT-EGFRI 18) Negative Breast Cancer ”. Dr . Chavez-MacGregor . Activated: 9/1/13 . Questionnaire for EGFRI-induced Skin Toxicities ”. Dr . Wong . Activated: S1404, “A Phase III Randomized Study of MK-3475 (Pembrolizumab) versus 11/15/11 . Closed to accrual 10/1/2016 . High-Dose Interferon alpha-2b for Resected High-Risk Melanoma ”. Dr . S1200, “Randomized Blinded Sham- and Waitlist-Controlled Trial of Grossmann . Activated: 10/15/15 . Closed: 8/15/17 . Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in S1718, “Phase III Trial of Early versus Delayed Therapy with Ibrutinib, Women with Early Stage Breast Cancer ”. Drs . Hershman and Crew . Venetoclax, and Obinutuzumab in Newly Diagnosed Asymptomatic High Activated: 4/1/12 . Closed: 2/15/17 . Risk Patients with CLL ”. Dr . Stephens .

37 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Symptom Control & Quality of Life Committee

S1612, “Patient-Centered Outcomes Concept: Investigation of Patient- CTSU/C51101, “A Randomized Phase II Trial of Myeloablative versus Reported Outcomes and Geriatric Assessent to Inform Treatment Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Decisions and Trial Design ”. Laura C . Michaelis, MD and Roland Primary CNS B-Cell Lymphoma ”. Dr . Mohile . Activated: 6/15/12 . B . Walter, MD . CTSU/C90203, “A Randomized Phase III Study of Neo-Adjuvant Docetaxel S1615/1712, “A Randomized Phase II Study of Ruxolitinib in Combination and Androgen Deprivation Prior to Radical Prostatectomy Versus with BCR-ABL Tyrosine Kinase Inhibitors in CML Patients with Evidence of Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Molecular Disease ”. Kendra Sweet, MD Localized Prostate Cancer ”. Dr . Kim . Activated: 12/15/06 . Closed to accrual 10/2/2015 . S1706, “Veliparib and Radiation Therapy for Inflammatory Breast Cancer ”. Reshma Jagsi, MD . CTSU/E1411, “Intergroup Randomized Phase II Four Arm Study in Patients with Previously Untreated Mantle Cell Lymphoma of Therapy with: Arm S1719, “Persistently Elevated CTCs in Chemotherapy-Refractory Metastatic A = Rituximab+Bendamustine Followed by Rituximab Consolidation Breast Cancer Treated with Combination Immune Checkpoint Inhibitors (RB -->R); Arm B = Rituximab+Bendamustine+Bortezomib Followed by (PRE-CHEK) ”. Erin Cobain, MD Rituximab Consolidation (RBV--> R), Arm C = Rituximab+Bendamustine S1802, “Standard Systemic Therapy (SST) Vs . SST plus Definitive Treatment Followed by Lenalidomide+Rituximab Consolidation (RB --> LR) (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate or Arm D = Rituximab+Bendamustine+Bortezomib Followed by Cancer ”. Brian Chapin, MD Lenalidomide+Rituximab Consolidation (RBV --> LR) ”. Dr . Till . Activated 6/15/12 . Closed: 9/9/16 . S1708, “A Randomized Trial of Aneteumab Ravtansine vs . Investigator’s Choice (Vinorelbine or Gemcitabine) in Previously Treated Patients with CTSU/E1609, “A Phase III Randomized Study of Adjuvant Ipilimumab Anti- Advanced Malignant Peritoneal Mesothelioma ”. Kanwal Raghav, MD CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma.” Dr. Flaherty. Activated: 5/25/11. Closed: 7/26/16. S1717, “Randomized Phase III Trial of the CancerTYPE ID Test in the Evaluation of Patients with Unknown Primary Cancer (CUP) ”. Sarah Yentz CTSU/E1912, “A Randomized Phase III Study of Ibrutinib (PCI-32765)-based MD and Laurence Baker, D O. . Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with CTSU/NRG-G1004, “Colorectal Cancer Metastatic MSI-High Chronic Lymphocytic Leukemia (CLL) ”. Dr . O’Brien . Activated 2/15/14 . Immunotherapy (COMMIT) Study: A Randomized Phase III Study of Closed: 6/916 . mFOLFOX6/Bevacizumab Combination Chemotherapy With or Without Atezolizumab or Atezolizumab Monotherapy in the First Line Treatment CTSU/E1A11, “Randomized Phase III Trial of Bortezomib, LENalidomide of Patients with MSI-H Metastatic Colorectal Cancer ”. Michael Overman, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, MD Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed CTSU/A021202, “Prospective Randomized Phase II Trial of Pazopanib Symptomatic Multiple Myeloma (ENDURANCE) ”. Dr . Zonder . Activated: (NSC #737754, IND 75648) Versus Placebo in Patients with Progressive 12/2/13 . Carcinoid Tumors ”. Dr . Phan . Activated: 6/21/13 . Closed: 10/7/16 . CTSU/E2810, “Randomized, Double-Blind Phase III Study of Pazopanib CTSU/A041202, “A Randomized Phase III Study of Bendamustine Plus vs . Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in No Evidence of Disease Following Metastatectomy ”. Dr . Pal . Activated: Untreated Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic 8/8/12 . Closed 7/25/17 . Leukemia (CLL)” . Dr . Coutre . Activated: 12/9/13 . Closed to accrual 5/16/16 . CTSU/E2906, “Phase III Randomized Trial of Clofarabine as Induction CTSU/C30610, “Phase III Comparison of Thoracic Radiotherapy Regimens in and Post-Remission Therapy vs . Standard Daunorubicin & Cytarabine Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin or Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Carboplatin and Etoposide ”. Drs . Gadgeel and Gaspar . Activated: 3/15/08 . Followed by Decitabine Maintenance vs . Observation in Newly- Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years) ”. Dr . Godwin . Activated: 12/28/10 . Temporarily closed: 2/23/15 .

38 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Symptom Control & Quality of Life Committee

CTSU/E3A06, “Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic High-Risk Symptom Control Smoldering Multiple Myeloma ”. Drs . Dhodapkar and Shaughnessy . Activated: 10/5/10 . Closed: 7/14/17 . & Quality of Life Committee

CTSU/EA6134, “A Randomized Phase III Trial of Dabrafenib + Trametinib Cumulative Accrual by Institution and Study Followed by Ipilimumab + Nivolumab at Progression vs . Ipilimumab For the Period Ending July 30, 2017 | Includes studies that are + Nivolumab Followed by Dabrafenib + Trametinib at Progression currently open, or that closed since Jan. 1, 2016. in Patients with Advanced BRAFV600 Mutant Melanoma ”. Dr . Chmielowski . Activated: 7/13/15 . S1013 S1200 A221101 A221102 Arkansas, U of — — 1 — - CTSU/N1048, “A Phase II/III trial of Neoadjuvant FOLFOX, with Selective CORA NCORP — — — 7 Use of Combined Modality Chemoradiation versus Preoperative CRC West MI NCORP — 68 — — Combined Modality Chemoradiation for Locally Advanced Rectal City of Hope Med Ctr 20 — — — 3 29 — — Cancer Patients Undergoing Low Anterior Resection with Total Columbia MU-NCORP Fred Hutchinson CRC — 11 — — Mesorectal Excision ”. Dr . Eng . Activated: 1/13/12 . Greenville NCORP — 15 — — Gulf South MU-NCORP 12 — — — CTSU/N107C, “A Phase III Trial of Post-Surgical Stereotactic Radiosurgery Heartland NCORP 61 — — — (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Irvine, U of CA — — 7 — Metastatic Brain Disease ”. Dr . Gaspar . Activated: 7/8/11 . Closed to Kaiser Perm NCORP — 56 — — 1 — — — accrual 12/18/15 . Kansas City NCORP Kansas, U of — — 1 — CTSU/R0848, “A Phase II-R and a Phase III Trial Evaluating Both Erlotinib Kentucky, U of — — 1 — Lahey Hosp & Med Ctr — 10 — — (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients Loma Linda Univ 1 — 1 — with Resected Head of Pancreas Adenocarcinoma ”. Dr . Philip . Activated: Northwest NCORP — — 1 — 12/15/09 . Oregon Hlth Sci Univ — 9 — — PCRC NCORP — 20 — 1 CTSU/R1010, “A Phase III Trial Evaluating the Addition of Trastuzumab Providence Hosp — — 2 — to Trimodality Treatment of HER2-Overexpressing Esophageal So Calif, U of 26 5 — — Southeast COR NCORP 5 — — — Adenocarcinoma ”. Dr . Leichman . Activated: 12/30/10 . Closed 11/10/15 . Sutter Cancer RC — — 1 2 — — 1 — Committee Process Upstate Carolina Utah, U of — 3 — — Sign and/or correct the meeting attendance/contact list Wayne State Univ 3 — — — Wichita NCORP 14 — — — Total 146 226 16 10

SWOG FACT SWOG conducts many large trials such as the Selenium and Vitamin E Cancer Prevention Trial (SELECT), a prostate cancer prevention study that enrolled more than 35,000 men . But the group also leads groundbreaking Phase I and Phase II studies to test new targeted therapies, and biospecimen studies that make use of the latest discoveries in cancer genetics .

39 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Early Therapeutics & Rare Cancers Committee

Leadership Presentations Chair: ...... Razelle Kurzrock, M .D . Vice-Chair: ...... Young Kwang Chae, M .D ., M .P .M .H ., M .B .A . 10:05 a.m. – 10:20 a.m.: “S1716: A Phase II Study of Brentuximab Vedotin Executive Officer: ...... Christopher W . Ryan, M .D . (BV) in CD30+ Systemic Mastocytosis and CMML ”. Uma Borate, M .D ., MS, Statisticians: ...... Megan Othus, Ph .D . Assistant Professor of Medicine, Oregon Health & Science University, ...... Melissa Plets, M .S . Knight Cancer Institute ...... Edward Mayerson, M .S . 10:20 a.m. – 10:40 a.m.: “S1717: Randomized Phase III trial of the Designates CancerTYPE ID test in the evaluation of patients with cancer of unknown Data Coordinators: ...... Laura Kingsbury, M .R T. . primary (CUP) ”. Sarah Yentz, M .D ., Hematology-Oncology Fellow; ...... Christine McLeod Laurence Baker, D O. ., Professor of Medicine; Former SWOG Chair, Oncology Research Professionals: University of Michigan Comprehensive Cancer Center CRA: ...... Corrine Turrell, C C. .R .P . Nurse: ...... TBD 10:40a.m. – 11:00a.m.: “Rare Cancer Fellowship, Hope Foundation July 1, Pharmaceutical Science: ...... Siu-Fun Wong, Pharm .D . 2017-June 30, 2017, Opportunities and Challenges ”. Victor M . Villalobos, Patient Advocate: ...... Marcia K . Horn, J .D . M .D ., Ph .D ., Assistant Professor of Medicine, Director, Sarcoma Medical Protocol Coordinator: ...... TBD Oncology, Director, Target-based Therapeutics Team (T3), University of Early Therapeutics Liaisons Colorado Denver, Anschutz Medical Campus Breast Committee Liaison: ...... George Somlo, M .D . 11:00 a.m. – 11:15 a.m.: “S1720: Efficacy and Safety of Laparoscopic Genitourinary Committee Liaison: ...... Neeraj Agarwal, M .D . Lymphadenectomy vs . PET/CT as a Classificatory Method for the Imaging: ...... Oliver Press, M .D . Treatment of Locally Advanced Cervical Cancer, A Phase III Randomized Lung Committee Liaison: ...... Shirish M . Gadgeel, M .D . Clinical Trial ”. Jesus Antonio Acosta Penaloza, M .D ., Co-Director, Instituto Lymphoma Committee Liaison: ...... Daruka Mahadevan, M .D ., Ph .D . Nacional de Cancerologia, Subdirreción General de Atención Médica y Melanoma Committee Liaison : ...... Jeffrey A . Sosman, M .D . Docencia, Instituto Nacional de Cancerología, Bogota, Colombia Myeloma Committee Liaison : ...... Frits van Rhee, M .D ., Ph .D . 11:15 a.m. – 11:45 a.m.: “Liquid biopsies in Precision Medicine,” Time/Location Filip Janku, MD, Associate Professor, Associate Professor, Investigational Thursday, October 12, 2017 10:00 a .m . - 12:15 p .m . Cancer Therapeutics, (Phase I Clinical Trials Program), The University of Regency C, Ballroom Level, West Tower Texas MD Anderson Cancer Center 11:45 a.m. – 12:05 p.m.: “Wrap-up Discussion of Dual Anti-CTLA-4 and Introduction Anti-PD-1 blockage in Rare Tumors (DART),” Sandip Patel, M .D ., Assistant 10:00 a.m. -10:05 a.m.: Razelle Kurzrock, M .D ., Senior Deputy Center Professor, UCSD Moores Cancer Center and Young K . Chae, M .D ., MPh, Director, Director, Center for Personalized Cancer Therapy, Chair, Early Assistant Professor, Co-Director, Experimental Therapeutics Program, Therapeutics and Rare Cancer Committee (SWOG), UCSD Moores Northwestern University Comprehensive Cancer Center, San Diego, CA 12:05 p.m. – 12:15 p.m.: Wrap Up and Open Discussion . Razelle Kurzrock, M .D ., Senior Deputy Center Director, Director, Center for Personalized Cancer Therapy, Chair, Early Therapeutics and Rare Cancer Committee (SWOG), UCSD Moores Comprehensive Cancer Center, San Diego, CA

40 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 SAN FRANCISCO, CA | APRIL 2017 Early Therapeutics & Rare Cancers Committee

Active Studies Early Therapeutics & S1609, “DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Rare Cancers Committee Tumors ”. Drs . P . Patel, Y . Chae, F . Giles, and R . Kurzrock . Activated: Cumulative Accrual by Institution and Study 1/13/17 . For the Period Ending July 30, 2017 | Includes studies that are CTSU/A071102 “A Phase II/III Randomized Trial of Veliparib or Placebo currently open, or that closed since Jan. 1, 2016. in Combination with Adjuvant Temozolomide in Newly Diagnosed S1609 A071102 A071401 ARST1321 EAY131 Glioblastoma with MGMT Promoter Hypermethylation ”. Dr . D .E . Arkansas, U of — — — — 3 Piccioni . Activated by Alliance 12/15/2014 . Activated by SWOG: Baptist MU-NCORP 2 — — — — 4/1/2015 . Temporarily closed: 10/21/16 . Baylor College — 2 — — — Brooke Army Med Ctr — 2 — — — CTSU/A071401 “Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive CORA NCORP 1 1 1 — 1 Meningiomas with SMO/AKT/ NF2 Mutations ”. Dr . D .E . Piccioni . Carle CC NCORP 2 — — — — 1 — — — 3 Activated by Alliance 8/28/2015 . Activated by SWOG: 1/1/2016 . Cedars-Sinai Med Ctr City of Hope Med Ctr — — — — 3 CTSU/ARST1321, “Pazopanib Neoadjuvant Trial in Non- Cleveland Clinic OH — — — — 4 Colorado, U of — 2 1 — 9 Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Columbus NCORP 1 — — — — Randomized Trial of Preoperative Chemoradiation or Preoperative Davis, U of CA 5 — — — 5 Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613) ”. Dr . Dayton NCORP 1 — — — 1 — — — — 2 V .M . Villalobos . Activated by COG 1/27/2014 . Activated by SWOG: Fred Hutchinson CRC Hawaii MU-NCORP — — — — 1 3/15/2016 . Heartland NCORP 4 — — — 1 Henry Ford Hosp 2 — — — 9 CTSU/EAY131 “Molecular Analysis for Therapy Choice (MATCH) ”. Dr . Irvine, U of CA — 1 1 — 5 V .M . Villalobos . Activated: 8/12/2015 . Kaiser Perm NCORP 7 3 — — 5 Kansas City NCORP — — — — 1 Proposed Studies Kansas, U of 2 — — 1 4 Kentucky, U of — — — — 8 S1618, “A Phase II Study of a selective JAK1 Inhibitor (INCB9110) in Lahey Hosp & Med Ctr — 3 — — — Subjects with Advanced Sarcomas ”. Dr . V .M . Villalobos . Loma Linda Univ — — — — 1 MD Anderson CC 1 — — — — S1716, “A Phase I/II study of Brentuximab Vedotin in CD30 + Systemic Methodist Hospital — — — — 1 Mastocytosis and CMML ”. Drs . U . Borate and A . Gerds . Michigan CRC NCORP 7 — — — — Michigan, U of 1 — — — 6 S1717, “Randomized Phase III trial of the CancerTYPE ID test in the Mississippi, Univ of — 1 — — — evaluation of patients with cancer of unknown primary (CUP) ”. Drs . S . Montana NCORP 4 — — — — Nevada CRF NCORP 2 — — — — Yentz and L . Baker . New Mexico MU-NCORP 4 — — — — 2 — — — — S1720, “Efficacy and Safety of Laparoscopic Extraperitoneal Para- Northwest NCORP Northwestern Univ — 1 — 1 — aortic Lymphadenectomy vs . PET/CT as a Classificatory Method Ozarks NCORP — 2 — — — for the Treatment of Locally Advanced Cervical Cancer, a Phase III PCRC NCORP 3 3 — — — Randomized Clinical Trial ”. Dr . J . Acosta . Providence Hosp 1 — — — 1 Rochester, Univ of — 8 — — — San Antonio, U of TX 1 — — 2 3 San Diego, U of CA 2 7 2 — — Southeast COR NCORP 4 — — — 6 Sutter Cancer RC 1 — — — 4 Tulane University — — — — 1 Yale University — 1 — — 7 Alliance 23 — — — — ECOG-ACRIN 9 — — — — NRG 20 — — — — Total 113 37 5 4 95

41 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Gastrointestinal Committee

Leadership Introduction . Howard Hochster, M .D ., Yale University . Chair: ...... Howard S . Hochster, M .D . Vice-Chair: ...... Heinz-Josef Lenz, M .D . “Treatment resistance to anti-EGFR therapy and ctDNA ”. Scott Kopetz, M .D ., Executive Officer: ...... Christopher W . Ryan, M .D . Ph .D ., MD Anderson Cancer Center . Statisticians: ...... Katherine A . Guthrie, Ph .D . Presentation of S1417, “Implementation of a Prospective Financial Impact ...... Shannon McDonough, M .S . Assessment Tool in Patients with Metastatic Colorectal Cancer ”. Veena Scientific Leadership Shankaran, M .D ., Fred Hutchinson Cancer Research Center . Gastroesophageal: ...... Syma Iqbal, M .D ...... Lawrence P . Leichman, M .D . Gastroesophageal ...... Scott A . Hundahl, M .D . (Surgical representative) No studies Pancreatic: ...... Philip A . Philip, M .D ., Ph .D ...... Andrew M . Lowy, M .D . (Surgical representative) Pancreatic Hepatobiliary: ...... Anthony B . El-Khoueiry, M .D . Active Studies ...... Milind Javle, M .D . S1505, “A Randomized Phase II Study of Perioperative mFOLFIRINOX ...... Syed Ahmad, M .D . (Surgical representative) versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Colon: ...... Philip J . Gold, M .D . Adenocarcinoma ”. Dr . Sohal . Activated: 10/12/15 ...... Wells A . Messersmith, M .D ...... Kevin G . Billingsley, M .D . (Surgical representative) S1513, “Randomized Phase II Study of 2nd Line FOLFIRI versus Modified Rectal: ...... Lisa A . Kachnic, M .D . FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in ...... Cathy. Eng, M .D . Metastatic Pancreatic Cancer ”. Dr . Chiorean . Activated: 9/1/16 . Translational Medicine: ...... Heinz-Josef Lenz, M .D . CTSU/RTOG 0848, “A Phase II-R and a Phase III Trial Evaluating Both ...... Christopher H . Lieu, M .D . Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Drug Development: ...... Ramesh Ramanathan, M .D . Patients with Resected Head of Pancreas Adenocarcinoma ”. Dr . Philip ...... Sunil Sharma, M .D . Activated: 12/15/09 . Imaging: ...... Anthony F . Shields, M .D ., Ph .D ...... David Shin-Kuo Lu, M .D . CTSU/A021501, “Preoperative Extended Chemotherapy vs Chemotherapy Radiation Oncology: ...... Lisa A . Kachnic, M .D . Plus Hypofractionated Radiation Therapy for Borderline Resectable Designates Adenocarcinoma of the Head of the Pancreas ”. Dr . Lieu . Activated: Cancer Control Liaison: ...... Jason A . Zell, D O. . 12/1/16 Data Coordinators: ...... Christine McLeod EA2142, “Randomized Phase II Study of Platinum and Etoposide Versus ...... Jacqueline Scurlock Temozolomide and Capecitabine in Patients with Advanced G3 Non- ...... Brian Zeller Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas” . Oncology Research Professionals: Activated 11/06/2015 . CRA: ...... Sandy Annis, C C. .R .P . Nurses: ...... Rita Kaul, R .N ., B .S .N . Proposed Studies ...... Valerie A . Parks, R .N . “A Phase II Study of CCR2 Inhibition testing Folfirinox in Combination with Patient Advocate (Pancreatic): ...... Carole Seigel, M .B .A . PF-04136309 vs Folfirinox Alone in Locally Advanced Pancreatic Cancer ”. Patient Advocate (Colon): ...... Florence Kurttila, M .S . Dr . Noel . Pharmaceutical Science: ...... Linda Lee-Gabel, Pharm .D ...... Manj Randhawa, Pharm .D . Closed Studies Protocol Coordinator: ...... Danae Campos S1313, “A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Time/Location Modified FOLFIRINOX Alone in Patients with Good Performance Status Friday, October 13, 2017 4:30 p .m . -6:30 p .m . Metastatic Pancreatic Adenocarcinoma ”. Dr . Ramanathan . Activated: Crystal B, Lobby Level, West Tower 1/15/14 . Closed: 7/1/17 .

42 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Gastrointestinal Committee

Hepatobiliary Other Active Studies Active Studies

CTSU/RTOG-1112, “Randomized Phase III Study of Sorafenib versus S1316, “Prospective Comparative Effectiveness Trial For Malignant Bowel Stereotactic Body Radiation Therapy Followed by Sorafenib in Obstruction ”. Dr . Krouse . Activated: 3/9/15 . Hepatocellular Carcinoma ”. Activated: 4/24/13 . S1609, “DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors ”. Colon Dr . Patel . Activated: 1/13/17 .

Active Studies EAY131, “NCI-MATCH: Molecular Analysis for Therapy Choice ”. Dr . Villalobos . Activated: 8/12/15 . S0820, “A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Closed Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Cancer, Phase III ”. Dr . Zell . Activated: 3/1/13 . Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus S1417CD, “Implementation of a Prospective Financial Impact Assessment (HBV), and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Tool in Patients with Metastatic Colorectal Cancer ”. Dr . Shankaran . Patients ”. Drs . Ramsey, Loomba, Chugh, Hershman and Hwang . Activated: 4/15/16 . Activated: 8/29/13 Closed: 2/15/17 .

S1415CD, “A Pragmatic Trial to Evaluate a Guideline-Based Colony Correlative Studies Stimulating Factor Standing Order Intervention and to Determine the S9008A, “Trial of Adjuvant Chemoradiation after Gastric Resection Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Adenocarcinoma, Phase III ”. Dr . Shridhar . Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia – Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) ”. Drs . S-C80405-A, “Analysis of EGFR and ERCC1 Markers and Progression- Ramsey and Hershman . Activated: 10/7/16 . Free Survival in Patients with Advanced Colorectal Cancer Enrolled on C80405 ”. Drs . Shields and Lenz . Proposed Studies Other Proposed Studies S1613, “A Randomized Phase II study of Trastuzumab and Pertuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in HER2 Amplified A Randomized Phase II/III Study of Gemcitabine and Cisplatin followed by Irinotecan-refractory Metastatic Colorectal Cancer (mCRC) ”. Dr . Raghav . Capecitabine/Radiation versus Gemcitabine and Cisplatin Alone . Dr . El-Khoueiry . Rectal Active Studies

CTSU/N1048, “A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision ”. Dr . Eng . Activated: 1/13/12 .

CTSU/EA2133, “InterAACT – An International Multicentre Open Label SWOG FACT Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin An average of 5,000 Plus 5-Fluorouracil Versus Carboplatin Plus Weekly Paclitaxel in Patients cancer patients and with Inoperable Locally Recurrent or Metastatic Disease ”. Dr . Morris . healthy participants enroll each year in SWOG studies, Activated: 2/15/16 . and approximately 20,000 CTSU/NRG-GI002, “A Phase II Clinical Trial Platform of Sensitization more are involved in ongoing clinical trials . Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer ”. Dr . Kachnic . Activated: 10/12/2016 .

43 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Gastrointestinal Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1313 S1406 S1505 S1513 A021202 A021501 E2211 E7208 E7208 EA2142 N1048 NRGGI002 R0848 NRGGI002 Arizona MC, U of 4 — — — — — — — — — 4 — — — Baptist MU-NCORP — 1 — — — — — — — — — — — — Baylor College — — — — — — — — — — 14 — — — Baylor Univ Med Ctr — — — — 2 — — — — — — — — — Boston Medical Ctr — — — — — — 1 — — — 2 — — — CORA NCORP — — — — — — — — — — 2 — — 1 CRC West MI NCORP — 1 — 2 — — — 1 — 2 — — 1 Carle CC NCORP ­— ­— ­1 ­— ­— ­— ­— ­— ­— ­— ­— ­— ­— Cedars-Sinai Med Ctr — — 2 1 — — 13 — — — — — — — Cincinnati MC, U of — — — — 4 — 13 — — — — — — — City of Hope Med Ctr — — 2 — — — 3 — — — — — — — Cleveland Clinic OH 3 3 — 2 — — — — — — — — — — Colorado, U of — 4 2 — — — 2 — — — 1 — — — Columbia MU-NCORP — 4 — 1 1 — — — — — 1 — — — Columbia University — — — 1 — — — — — — — — 2 — Columbus NCORP — — — — — — — — — — — — 2 — Davis, U of CA — 2 — — — — — — — — 2 — 1 — Dayton NCORP 1 — — — — — — — — — 2 — — — Essentia Hlth NCORP — — 1 1 — — — — — — 2 1 — — Fred Hutchinson CRC — 1 — — — — — — — — 14 — — — Greenville NCORP 14 — — — — — — — — — 14 — — — Gulf South MU-NCORP — 1 2 — — — 2 — — — — — 1 — H Lee Moffitt CC — 2 — 1 — — — — — — — — — — Hawaii MU-NCORP — — — — 22 — 10 — — — — — — — Heartland NCORP — — — — — — — — — — — — 1 — Irvine, U of CA 8 2 5 3 — — — — — — — — — — Kaiser Perm NCORP 7 1 — — — 1 — — — — 8 — 6 — Kansas City NCORP 7 — — — — — 1 — — — — — — — Kansas, U of — 3 — — 1 — 5 — 1 — — — 1 — Kentucky, U of — ­— 2 — — — 2 — — — — — — — Lahey Hosp & Med Ctr — — — — — — 1 ­— — — 11 — — — Since 1956, we’ve conducted more than 1,400 cancer clinical trials. Our research has made life longer, or better, for thousands of people. We expanded our patient advocate committee to 19 members, making it one of the largest, and the most experienced, groups in the NCTN.

44 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Gastrointestinal Committee, cont. Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1313 S1406 S1505 S1513 A021202 A021501 E2211 E7208 E7208 EA2142 N1048 NRGGI002 R0848 NRGGI002 Loyola University — — — — — — 1 — — — — — 4 — MD Anderson CC — 18 — — — — — — — — — — — — MUSC MU-NCORP 5 — 3 1 — — — — — — — — — — Methodist Hospital — — — — 1 — — — — — 10 — — — Michigan CRC NCORP — — — 2 — — — — — — — — — — Michigan, U of — 2 5 — — 2 1 1 — 2 4 — — — New Mexico MU-NCORP ­— — — 3 — — — — — — — — — — Northwest NCORP — ­1 ­— ­— ­— ­— ­— ­— ­— ­— ­— ­— ­3 ­— Northwestern Univ — — — — — — — 1 — — 1 — — — Orange Reg Med Ctr — — — — — — — — — — — 1 — — Oregon Hlth Sci Univ — — 1 — — — — — — — — — — — Ozarks NCORP — 1 — — — — — — — — 1 — — — PCRC NCORP 6 1 4 — — — — — — — 1 — — — Providence Hosp — 1 — — — — — 1 — — — — — — Rochester, Univ of — — 3 6 1 — 4 — — — 19 — — — San Antonio, U of TX — 1 — — 2 — — — — — — — — — San Diego, U of CA — — 4 — — — — — — — 4 — — — Scott & White Mem — — — — — — — 1 — — 1 — — — So Calif, U of 6 1 — — — — 2 6 — — — — — — Southeast COR NCORP 5 3 2 2 — — — — — — — — — — Sutter Cancer RC 9 1 — — — — — — — — — — — — Utah, U of — — — 6 — — — — — — 3 — — — Wayne State Univ 11 2 — — — — — 1 — — — — — — Wichita NCORP — — — — — — — — — — — — 1 — Wisconsin NCORP — — 3 1 — — — — — — — — — — Yale University 40 5 — 2 — — 2 11 — — — — — — Alliance — 19 9 9 — — — — — — — — — — ECOG-ACRIN — 10 14 6 — — — — — — — — — — NRG — 7 13 10 — — — — — — — — — — Total 126 106 81 66 35 3 55 23 1 2 124 2 20 1

We registered over 1,000 patients to Lung-MAP, our precision medicine trial Thanks, team!

45 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Genitourinary Committee

Leadership Introductions and Announcements - Ian M . Thompson, Jr ., M .D . Chair: ...... Ian M . Thompson, Jr ., M .D . Translational Medicine in the GU Committee - David J . McConkey, Vice-Chair: ...... Nicholas J . Vogelzang, M .D . Ph .D . and Christopher W . Ryan, M .D . Executive Officer: ...... Christopher W . Ryan, M .D . Statisticians: ...... Cathy M . Tangen, Dr .P .H . Cancer Control ...... Melissa Plets, M .S . Liaison: Dr . Peter J . Van Veldhuizen ...... Eddie Mayerson, M .S . Scientific Leadership Active Studies Translational Medicine: ...... David J . McConkey, Ph .D . S1316, “Prospective Comparative Effectiveness Trial for Malignant Bowel ...... Joshua J . Meeks, M .D ., Ph .D . (Bladder) Obstruction ”. Drs . Krouse, Badgwell, and Sun . Activated: 3/9/15 ...... Amir Goldkorn, M .D . (Prostate) ...... Brian Shuch, M .D . (Renal) Closed Studies Radiation Oncology: ...... David Raben, M .D . S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Imaging: ...... Daniel W . Lin, M .D . Screening for Human Immunodeficiency Virus (HIV), Hepatitis B virus ...... John D . Hazle, Ph .D . (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Pathology: ...... M . Scott Lucia, M .D . Patients ”. Drs . Ramsey, Loomba, Chugh, Hershman and Hwang . Liaison to the SPORES: ...... Colin P .N . Dinney, M .D . Activated: 8/29/13 . Closed: 2/15/17 . Early Therapeutics: ...... Neeraj Agarwal, M .D . Renal Bladder Organ Site Chairs: ...... Seth P . Lerner, M .D . (Localized) ...... Daniel P . Petrylak, M .D . (Advanced) Organ Site Chairs: Drs . Primo N . Lara, Jr . (Advanced) and Edward M . Messing Prostate Organ Site Chairs: ...... Daniel W . Lin, M .D . (Localized) (Local) ...... David I . Quinn, M .D ., Ph .D . (Advanced) Active Studies Renal Organ Site Chairs: ...... Edward M . Messing, M .D . (Localized) ...... Primo N . Lara, Jr ., M .D . (Advanced) S1500, “A Randomized, Phase II Efficacy Assessment of Multiple MET Designates Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Cancer Control: ...... Peter J . Van Veldhuizen, Jr ., M .D . Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Data Coordinators: ...... Diana Heaney Papillary Renal Carcinoma (PAPMET) ”. Drs . Pal, Lara, and Shuch . Activated: ...... Sean O’Bryan 4/5/16 ...... Joseph Sanchez CTSU/EA8143, “A Phase 3 Randomized Study Comparing Perioperative Oncology Research Professionals: Nivolumab vs . Observation in Patients with Localized Renal Cell CRA: ...... Theresa Witcher, R .N . Carcinoma Undergoing Nephrectomy (PROSPER RCC) ”. Drs . Lara and Nurses: ...... Deborah A . Shaw, R .N . Shuch . Activated: 2/2/17 ...... Cheryl Kefauver, R .N . Patient Advocates: ...... Rick Bangs, M .B .A . (Bladder) Closed Studies ...... Tony Crispino (Prostate) S0931, “EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A ...... Margaret “Peggy” Zuckerman, M .Ed . (Renal) Phase III Study ”. Drs . Ryan, Heath, Lara, Palapattu, and Mack . Activated: Pharmaceutical Science: ...... Joyce Lee, Pharm .D . 4/1/11 . Closed: 9/15/16 ...... Rivka Siden, Pharm .D . Prostate Protocol Coordinator: ...... Nicki Trevino Organ Site Chairs: Drs . David I . Quinn (Advanced) and Daniel W . Lin (Local)

Time/Location Active Studies Saturday, October 14, 2017 9:30 a .m . - 12:30 p .m . Regency A, Ballroom Level, West Tower CTSU/NRG-GU003, “A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT) ”. Dr . David Raben . Activated: 7/28/2017 .

46 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Genitourinary Committee

CTSU/NRG-GU002, “Phase II-III Trial of Adjuvant Radiotherapy and Closed Studies Androgen Deprivation Following Radical Prostatectomy with or without S1011, “A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus Adjuvant Docetaxel ”. Dr . David Raben . Activated: 12/30/2016 . an Extended Pelvic Lymphadenectomy Performed at Time of Radical CTSU/ A031102, “A Randomized Phase III Trial Comparing Conventional- Cystectomy for Muscle Invasive Urothelial Cancer ”. Drs . Lerner, Alva, Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with Koppie, LaRosa, Pal, and Svatek; R . Bangs . Activated: 8/1/11 . Closed: High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide 2/15/2017 . Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Diverse Studies of Interest Salvage Treatment in Relapsed or Refractory Germ Cell Tumors ”. Dr . Quinn . Activated: 7/1/15 . S1609, “DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors ”. Drs . Patel, Chae, Kurzrock, Giles . Activated: 1/13/17 . RTOG-0924, “Androgen Deprivation Therapy and High Dose Radiotherapy with or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate CTSU/EAY 131, “Molecular Analysis for Therapy Choice (MATCH) ”. Dr . or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial . Dr . Villalobos . Activated: 8/12/15 . David Marshall . Activated: 7/7/2011 .

Closed Studies SWOG FACT S1216, “A Phase III Randomized Trial Comparing Androgen Deprivation Among SWOG’s member sites are 28 National Cancer Institute- designated cancer centers, as well as many leading university Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide medical centers, private oncology practices, community in Patients with Newly Diagnosed Metastatic Hormone Sensitive hospitals, and community-based physician cooperatives . Prostate Cancer ”. Drs . Agarwal, Goldkorn, Gupta, Hussain, and Lara; T . Among the roughly 80 SWOG studies now underway are many Crispino . Activated: 3/1/13 . Closed 7/15/2017 . testing new targeted therapies that show promise in blocking cancer-promoting genes and cellular processes while sparing SWOG Champions needed: EA8173 healthy cells . Others break new ground as they test ways to tailor cancer treatment to a patient’s individual needs and genetic Bladder makeup . Still others examine ways to prevent cancer . Organ Site Chairs: Drs . Daniel P . Petrylak (Advanced) and Seth P . Lerner (Local)

Active Studies

S1602, “A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG Naïve High-Grade Non-Muscle Invasive Bladder Cancer ”. Dr . Svatek . Activated: 2/7/17 .

S1605, “Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ”. Drs . Black and Singh . Activated: 2/7/17 .

S1314, “A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN) Directed Neoadjuvant Chemotherapy for Localized, Muscle- Invasive Bladder Cancer ”. Drs . Flaig, Alva, Daneshmand, Goldkorn, Lerner, Lucia, McConkey, and Theodorescu . Activated: 7/9/14 .

CTSU/EA8141, “A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients with High Grade Upper Tract Urothelial Carcinoma ”. Drs . Godoy and Alva . Activated 4/10/15 .

47 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Genitourinary Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0931 S1011 S1216 S1314 S1500 S1602 S1605 A031102 A031201 E2810 EA8141 R0815 R0924 Arizona MC, 13 — 10 3 — — — — 10 — — — — Arkansas, U of 10 — 6 — — — — — 4 — — — — Atlanta Reg CCOP 7 — — — — — — — — — — — — BC Cancer Agency — 22 — — — — — — — — — — — Baptist MU-NCORP 3 — 1 — — — — — — — — — — Bay Area NCORP 1 — — — — — — — — — — — — Baylor College 21 51 16 3 — — — — 3 — — — — Beaumont NCORP 8 — 3 — — — — — — — — — — Birmingham, U of AL — — — 1 — — — — — — 1 — — Boston MC MBCCOP 1 — 3 — — — — — 11 — — — — Boston Medical Ctr 1 — — — — — — — — — — — — Brooke Army Med Ctr 2 — — — — — — — — — — — — CORA NCORP 7 — 2 — — — — — 3 — — 1 1 CRC West MI NCORP 15 — 4 — — — — — — — — — — Carle CC NCORP — — 2 — — — — — — — — — — Cedars-Sinai Med Ctr 13 — — — 1 — — — — — — — — Cincinnati MC, U of 6 — 1 — — — — — 3 — — — — City of Hope Med Ctr 41 — 49 7 11 — — — 22 16 — — — Cleveland Clinic OH — 7 — 10 — — — — 38 — — — — Colorado, U of 27 3 4 8 — — — — 5 — 5 — — Columbia MU-NCORP 6 — 2 — — — — — — 1 — — — Columbia University 3 — — — — — — — — — — — — Columbus NCORP 17 — 6 — — — — — — — — — — Davis, U of CA 13 12 37 3 — — — — 10 — — — — Dayton NCORP 16 — 9 — — — — — — — — — — Desert Hospital — — — — — — — — — — — 2 5 Fred Hutchinson CRC 2 — 28 — — — — — — — — — — Galveston, U of TX 1 — — — — — — — — — — — — Georgia NCORP 2 — 2 — — — — — 1 1 — — — Greenville NCORP 6 — — 2 — — — — — — — — — Gulf Coast MBCCOP 1 — — — — — — — — — — — — Gulf South MU-NCORP 17 4 2 3 — 7 1 — — — — — — H Lee Moffitt CC — 2 32 — — — — — — — — — — Harrison Medical Ctr — — — — — — — — 2 — — — — Hawaii MU-NCORP 13 — — — — — — — 1 — — — — Heartland NCORP 37 — 38 17 1 1 1 — 3 — — 2 — Henry Ford Hosp 8 — — — — — — — 14 1 — — — Irvine, U of CA 8 — 6 — — — — — 2 — — — — Kaiser Perm NCORP 14 — 83 — — — — — 97 — — — — Kansas City NCORP 7­ —­ 6 —­ —­ —­ —­ —­ —­ —­ —­ —­ —­ Kansas, U of 29 — 29 10 — — — — 9 6 1 — 2 Kentucky, U of —­ —­ 16­ —­ —­ —­ —­ —­ —­ —­ —­ —­ —­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­ ­

48 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Genitourinary Committee, cont. Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0931 S1011 S1216 S1314 S1500 S1602 S1605 A031102 A031201 E2810 EA8141 R0815 R0924 Lahey Hosp & Med Ctr 2 — 3 — — — — — — — — — — Loma Linda Univ — — 13 5 — — — — 3 — — — — Loyola University 32 15 6 2 — — — — 2 1 — 3 — MAVERIC — — — — — — — — 5 — — — — MD Anderson CC — 49 4 1 — — — — — — 1 — — MUSC MU-NCORP 1 — 12 1 1 — — — — — — 1 2 Madigan Army Med Ctr 3 — 2 — — — — — — — — — — Michigan CRC NCORP 20 — 17 3 1 — — — — — — — — Michigan, U of 34 — 17 — 2 3 — — — 1 — — — Mississippi, Univ of 3 — 1 — — — — — — — — — — Montana NCORP 10 — 3 2 — — — — — — — — — Nevada CRF NCORP 11 — 45 9 2 — — — — — — — — New Mexico MU-NCORP 2 — 26 — — — — — — — — — — Northwest NCORP 15 — 4 — — — — — — — — — — Northwestern Univ — — 3 — — — — — — — — — — Oklahoma, Univ of 6 — 16 5 1 1 1 — — — — — — Orange Reg Med Ctr 1 — 1 — — — — — — — — — — Oregon Hlth Sci Univ 22 19 21 3 1 — — — — 6 — — — Ozarks NCORP 13 — 5 2 — — — — — — — — — PCRC NCORP 31 — 7 — — 2 — — — — — — — Rochester, Univ of 14 1 7 5 — — — — 6 — — 2 15 San Antonio, U of TX 27 50 3 8 — 1 — — — — — — — San Diego, U of CA — — 6 1 — — — — — — — — — Scott & White CCOP 3 — — — — — — — — — — — — Scott & White Mem 2 — — — — — — — — — — — — So Calif, U of 9 153 34 10 — — — 2 11 1 — 1 — Southeast COR NCORP 32 — 6 1 — — — — — 1 — — — St Louis CCOP 4 — — — — — — — — — — — — St Louis University 1 — — — — — — — — — — — — Sutter Cancer RC 23 — 5 — — — — — 1 — — — 1 Tennessee, U of 5 — — — — — — — 12 1 — — — Upstate Carolina 1 — 1 — — — — — — — — — — Utah, U of 25 — 106 5 1 1 — — — 12 — — — VAMC Kansas City — — 2 — — — — — 1 — — — 21 Wayne State Univ 15 — — 1 2 — — — 6 — — 1 — Wichita NCORP 23 — 12 1 1 1 — — — — — — — Wisconsin NCORP 1 — 2 2 — — — — — — — — — Yale University 6 — 7 1 — — — — — — — — — Alliance 297 105 239 39 5 — 2 — — — — — — CCTG —­ 38­ —­ —­ 2­ —­ —­ —­ —­ —­ —­ —­ —­ ECOG-ACRIN 396 87 240 18 6 — — — — — — — — NRG 78 — 40 16 5 —­ 1 — —­ — —­ — —­ Total 1,545­ 618­ 1,313­ 208­ 43 16­ 6­ 2­ 287­ 48­ 8­ 13­ 48­ ­

49 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Leukemia Committee

Leadership Proposed Studies Chair: ...... Harry P . Erba, M .D ., Ph .D . Vice-Chair: ...... Steven E . Coutre, M .D . S1612, “A Randomized Phase II/III Trials of “Novel Therapeutic Regimens” Executive Officer: ...... Susan M . O’Brien, M .D . versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Statisticians: ...... Megan Othus, Ph .D . Leukemia Age 60 or Older ”. Drs . L . Michaelis and R . Walter ...... Anna Moseley, M .S . Scientific Leadership Translational Medicine: ...... Jerald P . Radich, M .D . S1804, “Optimization of Gemtuzumab Ozogamicin in Combination Pathology: ...... David R . Head, M .D . with Chemotherapy for Adults with Newly Diagnosed Favorable- or Cytogenetics Liaison: ...... Diane Roulston, Ph .D . Intermediate-Risk Acute Myeloid Leukemia (AML): A Randomized Phase II ...... Min Fang, M .D ., Ph .D . Study ”. Dr . R . Walter . Designates Closed Studies Data Coordinators: ...... Louise Highleyman ...... Laura Kingsbury, M .R T. . S0919, “A Phase II Study of Idarubicin and Ara-C in Combination with ...... Tracy Maher, C C. .R .P . Pravastatin for Poor-Risk Acute Myelogenous Leukemia (AML) ”. Drs . A .S . Oncology Research Professionals: Advani and L C. . Michaelis . Activated: 8/15/09 . Closed: 9/15/17 CRA: ...... TBD ALL Studies Nurses: ...... Keisha C . Humphries, R .N ., B .S .N ...... Mary Lynn Rush, R .N ., B .S .N . Active Studies Patient Advocate: ...... Gail Sperling, M .P .H . S1318, “A Phase II Study of Blinatumomab (NSC-765986) and POMP Pharmaceutical Science: ...... Holly O . Chan, Pharm .D . (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients ...... Mai T . Nguyen, Pharm .D . >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Protocol Coordinator: ...... Sandi Hita Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years Time/Location of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) Saturday, October 14, 2017 9:30 a .m . - 11:30 a .m . ALL ”. Drs . A .S . Advani and K . O’Dwyer . Activated: 1/12/2015 . Regency C, Ballroom Level, West Tower S1312, “A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) Introduction for Patients with Relapsed/Refractory CD22-Positive Acute Leukemia Leukemia Committee Updates – Dr . Harry Erba (Including B-ALL, Mixed Phenotypic Leukemia and Burkitt’s Leukemia) ”. AML/MDS Studies Drs . A .S . Advani and M . Liedtke . Activated: 4/1/14 . Active Studies CTSU/E1910, “A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia “Randomized Phase III Trial Comparing the Frequency CTSU/E2905, in Adults ”. Dr . M . Liedtke . Activated by ECOG: 12/17/13 . Activated by of Major Erythroid Response (MER) to Treatment with Lenalidomide SWOG: 1/15/14 . (Revlimid®) Alone and in Combination with Epoetin Alpha (Procrit®) in Subjects with Low-or Intermediate-1 Risk MDS and Symptomatic Proposed Studies Anemia ”. Dr . C .A . Schiffer . Activated by ECOG: 1/29/09; Activated by S1704, “A Phase II Trial of PR-104 in Relapsed/Refractory Patients with T-cell SWOG: 2/15/09 . Acute Lymphoblastic Leukemia ”. Drs . A .S . Advani and W . Stock .

50 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Leukemia Committee

Ozogamicin for Patients with Relapsed/Refractory CD22+ Acute Lymphoblastic Leukemia (ALL) ”. Drs . A .S . Advani and C . Yeung .

A041501, “A Phase III Trial to Evaluate the Efficacy of the Addition SWOG: Who we are of Inotuzumab ozogamicin (a conjugated anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 16-39 years) with Newly Diagnosed Precursor B-Cell ALL ”. Dr . A .S . Advani .

CTSU/EXXXX, “A Phase II Randomized Trial of Steroids + TKI Induction with Chemotherapy or Blinatumomab and Allo-HCT for Newly Diagnosed BCR-ABL-positive ALL in Adults ”. Drs . Kathleen Phelan, Yishai Ofran, and Katarzyna Jamieson .

CLL Studies Active Studies

CTSU/E1912, “A Randomized Phase III Study of Ibrutinib (PCI-32765)- based Therapy vs . Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Dr. Veena Patients with Chronic Lymphocytic Leukemia (CLL) ”. Dr . S . O’Brien . Shankaran Activated by ECOG: 1/31/14; Activated by SWOG: 2/15/14 . launched the first financial Closed Studies toxicity trial in the CTSU/A041202, “A Randomized Phase III Study of Bendamustine National Clinical plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Trials Network Alone in Untreated Older Patients (≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL) ”. Dr . S .E . Coutre . Activated by Alliance: 12/9/13; Activated by SWOG: 12/15/13 .

Proposed Studies

S1718, “Randomized, Phase III Study of Early Intervention with Ibrutinib or Ibrutinib, Venetoclax, and Obinutuzumab (I-V-O) versus Delayed Therapy with I-V-O in Newly Diagnosed Asymptomatic Patients with High-Risk Chronic Lymphocytic Leukemia (CLL) ”. Drs . D . Stephens and A . Danilov .

CML Studies Proposed Studies

S1712, “A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors Chronic Myeloid Leukemia Dr. Manuel Patients with Evidence of Molecular Disease ”. Drs . K . Sweet and J . Valdivieso Radich . (Formerly S1615) is the SWOG executive officer overseeing international initiatives

51 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Leukemia Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0919 S1312 S1318 A041202 E1910 E1912 E2905 E2906 NHLBIMDS Arizona MC, U of — — — 3 3 — — 7 — Arkansas, U of — — 1 1 3 8 — — — Baptist MU-NCORP — — — 1 — — — — — Baylor College 5 4 — — — — — — — Beaumont NCORP — — — — — 6 — — — Birmingham, U of AL 3 — 1 — 6 1 — — — Boston Medical Ctr — — — 2 — — — — — CORA NCORP — — — 2 — 1 1 — — CRC West MI NCORP — — — — — — — 4 — Cincinnati MC, U of — — — — — — — 3 — City of Hope Med Ctr — 13 4 7 — — — — — Cleveland Clinic OH 23 10 4 7 4 — — — 1 Colorado, U of 6 — — 1 — — 2 — — Columbia MU-NCORP — — — — — — 1 3 — Columbia University — — — — — — 1 — — Columbus NCORP — — — 1 — — — — — Davis, U of CA — — — — — — 5 — — Dayton NCORP — — — — — — — 5 — Fred Hutchinson CRC — — — — — 8 — — — Greenville NCORP — — 1 — 1 1 6 — — Gulf South MU-NCORP 1 — — — — — — — — H Lee Moffitt CC 11 — — — — — 29 — 1 Harrington CC — — — — — 1 — — — Heartland NCORP — ­ — ­ 1 ­ — ­ — ­ — ­ —­ —­ —­ Henry Ford Hosp — — — — 2 — 1 — — Irvine, U of CA — ­ — ­ 3 ­ 2 ­ 4 ­ 1 ­ —­ —­ —­ Kaiser Perm NCORP ­— ­— ­— ­31 ­— 29­ ­7 ­— 1 Kansas City NCORP — — — — — 1 2 — — Kansas, U of — — — 6 8 1 1 — — Kentucky, U of — ­ — ­ — ­ — ­ — ­ — ­ —­ 7­ —­ Lahey Hosp & Med Ctr — — — 2 — 2 — — —

Our History Dr. Grant Taylor, Founded in 1956 by the National Cancer Institute, we are part of the NCI’s first SWOG National Clinical Trials Network, the largest and oldest publicly funded cancer group chair research network in the United States. We are also part of NCI’s Community Oncology Research Program, which connects us to community hospitals and clinics across the nation – and the diverse populations they serve.

Our members include more than 12,000 research professionals working in 47 states and six other countries, and our bio-repository holds more than 800,000 specimens accessible to fellow researchers around the world.

52 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Leukemia Committee, cont. Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0919 S1312 S1318 A041202 E1910 E1912 E2905 E2906 NHLBIMDS Loma Linda Univ — — 1 — — — — — — Loyola University 4 — — — — 3 — 9 — MAVERIC — — — 1 — — — — — Michigan, U of — — 2 — — — — — — Mississippi, Univ of 1 — — — — — — 1 — Montana NCORP — — — — — 3 4 — — New Mexico MU-NCORP 5 — 1 — — — — 1 — Northwest NCORP — — — — 5 1 — — — Northwestern Univ — — — 2 1 2 — — — Orange Reg Med Ctr — — — 3 — 1 — — — Oregon Hlth Sci Univ 6 — — — — — — — 2 Ozarks NCORP — — — — — 1 — — — PCRC NCORP 2 — — 1 — 1 1 — — Providence Hosp — — — — — 1 2 — — Rochester, Univ of 15 7 1 10 4 24 3 27 — San Antonio, U of TX — — — 1 — 2 3 — — San Diego, U of CA — — 1 — 3 — — — — So Calif, U of — — 3 — — — — — — Southeast COR NCORP — — — — — — 1 — — Stanford University 24 2 — 6 6 21 — — — Sutter Cancer RC — — — 1 — 2 — — — Tulane Univ MBCCOP 1 — — — — — — — — Tulane University 2 — — — — — — — — Upstate Carolina — ­ — ­ — — ­ — ­ — —­ 3­ —­ Wayne State Univ — — — 2 1 3 ­ 5 — — Wichita NCORP 6­ —­ 1­ —­ —­ — —­ —­ —­ Yale University ­— ­— ­— ­6 ­13 5 6 ­5 ­— Alliance — — 13 — — —­ — — — ECOG-ACRIN — — 6 — — — — — — Total 115 36 44 ­ 99 ­ 64 ­ 130 81­ 75­ 4

SWOG Offices 2 Our 2016 Highlights 1. The Hope Foundation, 3 • We tipped our member scales at over Ann Arbor, MI 1,000 sites across the U.S. and six 1 2. SWOG Statistics and other countries Data Management • We registered over 1,000 patients to Center, Fred Hutchinson Lung-MAP, our precision medicine trial Cancer Research Center, • We trained about 300 clinical trial Seattle, WA professionals in Mexico City, Peru, 3. SWOG Group Chair’s Office, 4 and Columbia under our SWOG Latin Knight Cancer Institute at America Initiative Oregon Health & Science University, Portland, OR 4. SWOG Operations, San Antonio, TX • We applied for, and received, over $2.4 million in National Institutes of Health supplemental funding for our trials

53 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Lung Committee

Leadership of Radiation Oncology, MD Anderson Cancer Center Chair: ...... Karen Kelly, M .D . Vice-Chair: ...... Roy S . Herbst, M .D ., Ph .D . • Update on Current Trials Executive Officer: ...... Julie R . Gralow, M .D . • Review of Trials in Development Statisticians: ...... Mary Redman, Ph .D ...... Jieling Miao, M .S . 5:30 p.m.: Thoracic Radiation Session – Dr . Decker ...... James Moon, M .S . • Scientific Presentation - Treatment of Brain Metastasis ...... Katherine Griffin, M .S . Joseph N . Contessa, M .D ., Ph .D ., Associate Professor of Scientific Leadership Therapeutic Radiology and of Pharmacology; Director, Central Translational Medicine: ...... Philip C . Mack, Ph .D . Nervous System Radiotherapy Program, Yale Cancer Center ...... Fred R . Hirsch, M .D ., Ph .D . Radiation Oncology: ...... Roy H . Decker, M .D ., Ph .D . • Update on Current Trials Surgery: ...... Wayne L . Hofstetter, M .D . • Review of Trials in Development Imaging: ...... Anthony F . Shields, M .D ., Ph .D ...... Friedrich D . Knollmann, M .D ., Ph .D . 6.10 p.m.: Translational Medicine Session – Dr . Mack Pathology: ...... Ignacio I . Wistuba, M .D . • Update Early Therapeutics: ...... Shirish M . Gadgeel, M .D . Designates 6:30 p.m.: Thoracic Oncology Session Cancer Control Liaison: ...... Gary E . Goodman, M .D . • Scientific Presentations: Community Affiliate: ...... Paul J . Hesketh, M .D . Data Coordinators: ...... Krystle Pagarigan ESMO 2017 Lung Cancer Update . Karen Kelly M .D ., Professor, ...... Louise Highleyman UC Davis Comprehensive Cancer Center ...... Larry Kaye Advances in Mesothelioma . Anne S . Tsao, M .D ., Professor and ...... Sarah Basse Director of the Mesothelioma Program, MD Anderson Cancer Oncology Research Professionals: Center CRAs: ...... Courtney L . Williamson ...... Ginny M . Keeling, M .S . 7:00 p.m.: Mesothelioma Nurses: ...... Kimberly M . Belzer, M .S ., P .A C. • Update on Current Trials ...... Rosalie Zablocki, R .N . Patient Advocate: ...... Judy Johnson, M .B .A . • Review of Trials in Development Pharmaceutical Science: ...... Joyce Lee, Pharm .D . Thymic Carcinoma ...... Linda Lee-Gabel, Pharm .D . Protocol Coordinator: ...... Dawne Wenzel . M .A ., M .S . • Review of Trials in Development ...... Crystal Miwa (Lung-MAP Protocol) NSCLC

Time/Location • Update on Current Trials Thursday, October 12, 2017 4:45 p .m . - 7:45 p .m . • Review of Trials in Development Regency D, Ballroom Level, West Tower Small Cell Lung Cancer 4:45 p.m. : Opening Remarks and General Update – Dr . Kelly • Update on Current Trials Patient Advocate Judy Johnson • Review of Trials in Development 5:00 p.m.: Thoracic Surgery Session – Dr . Hofstetter Active Studies Scientific Presentation - Local treatment for oligometastatic • S1507, “A Phase II Trial of Trametinib with Docetaxel in Patients with Kras disease . Daniel Gomez, M .D ., Associate Professor, Department Mutation Positive Non-small Cell Lung Cancer (NSCLC) and Progressive

54 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Lung Committee

Disease Following One or Two Prior Systemic Therapies ”. Drs . Gadgeel, with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Riess and Mack . Activated: 7/17/16 . Protein ”. Dr . Li . Activated: 8/18/14 .

S1403, “A Randomized Phase II/III Trial of Afatinib Plus Cetuximab versus CTSU/R1306, “A Randomized Phase II Study of Individualized Combined Afatinib Alone in Treatment-Naïve Patients with Advanced, EGFR Modality Therapy for Stage III Non-Small Cell Lung Cancer ”. Drs . Tsao Mutation Positive Non-Small Cell Lung Cancer (NSCLC) ”. Drs . Goldberg, and Daly . Activated: 11/4/13 . Lilenbaum and Politi . Activated: 3/25/15 . CTSU/CALGB 30610, “Phase III Comparison of Thoracic Radiotherapy S1400, “A Biomarker-Driven Master Protocol for Previously Treated Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Squamous Cell Lung Cancer ”. Drs . Papadimitrakopoulou, Hirsch, Herbst, Cisplatin or Carboplatin and Etoposide ”. Drs . Gadgeel and Gaspar . Schwartz, Gandara and Mack . Activated: 6/16/14 . Activated: 3/15/08 .

S1400G, “A Phase II Study of Talazoparib (BMN 673) in Patients with NCI Approved Concepts Homologous Recombination Repair Deficiency Positive Stage IV S1619. “A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed with Squamous Cell Lung Cancer (Lung-MAP Sub-study) ”. Drs . Owonikoko Atezolizumab in Combination and in Maintenance for Resectable and Byers . Activated: 2/7/17 . Malignant Pleural Mesothelioma ”. Dr . Tsao . S1400I, “A Phase III Randomized Study of Nivolumab plus Ipilimumab S1701, “A Phase II Trial of Carboplatin, Paclitaxel, and Ramucirumab versus Nivolumab for Previously Treated Patients with Stage IV in Patients with Locally Advanced, Metastatic, or Recurrent Thymic Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP Epithelial Tumors (TET) not Amenable to Curative Intent Surgery ”. Dr . Sub-study) ”. Drs . Gettinger and Bazhenova . Activated: 12/18/15 . Tsao . S1206 (8811), “A Dose Finding Study Followed by Phase II Randomized, S1400F, “A Phase II Study of MEDI4736 Plus Tremelimumab as Therapy Placebo-Controlled Study of Veliparib (ABT-888) Added to for Patients with Previously Treated anti-PD-1/PD-L1 Resistant Stage IV Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study) ”. Drs . Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811) ”. Leighl and Rizvi . Drs . Argiris, Cristea and Chen . Ac-tivated: 10/1/12; Phase II open: 7/15/16 . S1400K, “A Phase II Study of ABBV-399 in Patients with c-MET Positive CTSU/EAY131, “Molecular Analysis for Therapy Choice (MATCH) ”. Dr . Stage IV or Recurrent Squa-mous Cell Lung Cancer (Lung-MAP Sub- Villalobos . Activated: 8/12/15 . Study) ”. Drs . Waqar and Hashemi CTSU/A151216, “Adjuvant Lung Cancer Enrichment Marker Identification S1400GEN, “Ancillary Study to Evaluate Patient and Physician Knowledge, and Sequencing Trial (ALCHE-MIST) ”. Dr . Gandara . Activated: 8/18/14 . Attitudes, and Preferences Related to Return of Genomic Results in CTSU/A081105, “Randomized Study of Erlotinib versus Observation S1400 ”. Drs . Ramsey and Roth . in Patients with Completely Resect-ed Epidermal Growth Factor S1800, “A Master Protocol to Evaluate Biomarker-Driven and Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC) ”. Dr . Kelly . Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer Activated: 8/18/14 . (Lung-MAP Sub-Study) ”. Drs . Papadimitrakopoulou, Herbst, and Gandara CTSU/EA5142, “Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) – A EA5163/S1709, “A Randomized Phase III Study for PD-L1 Positive Advanced Randomized Phase III Study of Nivolumab after Surgical Resection and Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients Treated Adjuvant Chemotherapy in Non-Small Cell Lung Cancers ”. Jamie E . Chaft, with Pembrolizumab in Induction or Maintenance Therapy with M .D . Activated: 5/6/16 . Immunosignature-Driven Analysis ”. Drs . Chiang and Borghaei . CTSU/NRGCC003, “Randomized Phase II/III Trial of Prophylactic Cranial Concepts in Development Irradiation With or Without Hip-pocampal Avoidance For Small Cell Lung Cancer ”. Vinai Gondi, MD . Activated on 12/07/2015 . ALLIANCE/SWOG. “Phase III Study of Pembrolizumab (MK-3475) vs . Gemcitabine for Second Line Treatment of Malignant Pleural “A Randomized Phase III Trial for Surgically Resected Early CTSU/E4512, Mesothelioma ”. Drs . Garland and Verschraegen . Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients

55 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Lung Committee

“Randomized Phase II Trial to Test the Efficacy of Nintedanib in Combination “A Randomized Phase II Study of Irinotecan versus Irinotecan plus with Cisplatin and Etopo-side for Subjects with Previously Untreated Atezolizumab in Patients with Relapsed or Refractory Small Cell Lung Extensive Stage Small Cell Lung Cancer ”. Dr . Heymach and Dr . Chae . Cancer (SCLC) ”. Drs . Karim and Reckamp .

“A Phase II Study of Pembrolizumab Concurrent with Radiotherapy PCI vs Active MRI Surveillance in Small-Cell Lung Cancer . Dr . Chad Followed by Pembrolizumab Mainte-nance in Patients with Stage III Non- Rusthoven . Small Cell Lung Cancer (NSCLC) With Borderline Performance Status ”. Drs . Aljumaily and Mitin . Mentors: Drs . Decker and Wozniack . Lung Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0905 S1206 S1300 S1400 S1400B S1400C S1400D S1400G S1400I S1403 S1507 A081105 A151216 C140503 C30607 C30610 C30901 E4512 EA5142 NRGCC003 R1306 Arizona MC, U of — 3 — 1 — — — — — — — — 1 — — — — — — — — Arkansas, U of 2 — — 3 — — 1 — — — — — — 1 — 2 — — — — — Baptist MU-NCORP — — — 10 — 1 — — 5 1 1 — 15 — — 1 — — — — — Beaumont NCORP — — — 2 — 1 — — — — — — — — — — — — — — — Boston Medical Ctr — — — 4 — — — — 2 — — — 2 — — — — — — — — Brooke Army Med Ctr — — — 6 — — — — 2 — — — 6 — — — — — — — — CORA NCORP — — — 7 1 1 — — 2 — — — 2 — — — — — — — — CRC West MI NCORP — — — 9 — — — — 1 2 — — — — — — — — — — — Carle CC NCORP — — — 3 — — 1 — 2 — — — — — — — — — — — — Cincinnati MC, U of — — — 4 — — — — 1 — — — 7 — — 3 — 1 — — — City of Hope Med Ctr — 2 — 12 — 1 — — 2 — — 1 4 — — — — — — — — Cleveland Clinic OH — — — 9 — — — — — — 1 2 11 — — — 1 — — — — Colorado, U of — — 1 2 — 1 — — 1 — — 2 10 12 — — — — — 1 1 Columbia MU-NCORP — — — 2 — — — — — — — — — — — — — — — — — Columbus NCORP — — — 11 2 1 — — 1 3 — — — — — 1 — — — — — Cookeville Reg MC — — — 10 — — 2 — — — — — — — — — — — — — — Davis, U of CA 1 9 — 17 — 2 — 2 3 4 2 1 21 6 — 11 1 1 — — — Dayton NCORP — 1 — 4 — — — — 1 1 — — 1 — — — — — 1 — — Essentia Hlth NCORP — — — 7 — 2 — — 2 — — — — — — — — — — — — Franciscan Res Ctr 1 — — — — — — — — — — — — — — — — — — — — Fred Hutchinson CRC — — — 17 1 1 — 1 3 — — 1 5 — — — — — — — — Georgia NCORP 2 — — 6 — — — — 4 — 1 — — — — 1 — — — — — Greenville NCOR 2 — — 12 1 — 1 1 4 2 — — — — — — — — — — — Gulf South MU-NCORP — — — 6 — — — 1 — — — — — — — — — — — — — H Lee Moffitt CC — — — 9 — — — — — — — 1 23 — — — — — — — — Harrington CC — — — 6 — 1 — — — — — — — — — — — — — — — Harrison Medical Ctr 1 — — — — — — — — — — — — — — — — — — — — Hawaii MU-NCORP — 3 — 6 — — — — 1 4 — — — — — — — — — — — Heartland NCORP 8 7 — 39 — 2 1 — 6 1 4 — — — 2 7 — — — — — Henry Ford Hosp 3 2 — 7 1 — — — — — — 1 13 — — — — — 2 — — Irvine, U of CA — — — 8 — — — — 2 — 1 2 4 — — — — — — — — Kaiser Perm NCORP 8 — — 37 — 4 1 — 4 21 — 9 89 — — 2 — 1 — — — Kansas City NCORP — — — 1 — — — — — — — — — — — — — — — — — Kansas, U of 1 — — 32 — — — — 10 1 — — 17 — — 1 — — 2 — — Kentucky, U of — — — 8 — — 1 — 3 — — — — — — — — — — — — Lahey Hosp & Med Ctr — 1 — 8 — 1 — — 1 3 1 — 10 — — — — — 2 — 2 Loma Linda Univ — — — 4 — — — 1 1 — 1 — 1 — — — — — — — — Loyola University — 4 — 9 — 1 — — 3 — — — 4 — — — — — 2 — — MAVERIC — — — 13 1 2 — — 7 — — — — — — — — — — — —

56 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

More than 3 million yearsof human life saved. Let’s Make More Time

Leading cancer research. Together.

Lung Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S0905 S1206 S1300 S1400 S1400B S1400C S1400D S1400G S1400I S1403 S1507 A081105 A151216 C140503 C30607 C30610 C30901 E4512 EA5142 NRGCC003 R1306 MD Anderson CC 55 3 — 16 — — 1 — 1 — — — — — — — — — — — 5 MUSC MU-NCORP — — — 1 — — — — — — 2 — — — — 1 — — — — — Methodist Hospital — — — 5 — — — — — — — 1 4 — — — — — — — — Michigan CRC NCORP 4 — — 26 2 — 1 2 2 6 1 — — — — — — — — — — Michigan, U of 7 — — 12 1 2 — — 3 3 — — 34 — — 1 — — — — — Mississippi, Univ of 4 — — 6 1 — — — 3 — — — 4 — — 1 — — — — — Montana NCORP 5 — — 13 1 2 — — 2 2 — — — — — — — — — — — Nevada CRF NCORP — — — 4 — — — — 3 — — — — — — — — — — — — New Mexico MU-NCORP — — — 5 — — — — — 1 — — — — — — — — — — — Northwest NCORP — — — 4 — — — — — — — — — — — — — — — — — Northwestern Univ — — — 1 — — — — — — — — — — — — — — — — — Oklahoma, Univ of — — — 8 — — 1 1 2 4 — — — — — — — — — — — Orange Reg Med Ctr — — — — — — — — — — — — — — — — 1 — — — — Oregon Hlth Sci Univ — — — 6 — — — — 4 — — — — — — — — — — — — Ozarks NCORP — — — 16 — 1 1 — 2 1 1 1 1 — — — — — — — — PCRC NCORP 2 — — 13 1 — — — — — — — 4 6 — — — — — — — Providence Hosp — — — 9 — — — — — — — — 9 — — 2 — 1 1 — — Rochester, Univ of — — — 15 — 1 — 1 1 1 1 — — — — — — — — 3 — San Antonio, U of TX — — — 11 1 1 3 — 2 4 — — — — — 3 — — — — — San Diego, U of CA — — — 9 — — — — 1 6 — — 3 — — — — — — — — So Calif, U of 3 — — — — — — — — — — — 5 — — — — — — — — Southeast COR NCORP 3 1 — 34 1 — 1 — 9 1 — — — — — — — — — — — Sutter Cancer RC — — — 3 — — — — — — — 1 4 — — — — — 2 — — Tennessee, U of — — — — — — — — — — — — — 2 — — — — — — — Tulane Univ MBCCOP — — — 3 — — — — — — — — — — — — — — — — — Univ of Louisville — — — — — — — — — — — — 5 — — — — — — — — Upstate Carolina — — — 2 — — — — — — — — — — — — — — — — — Utah, U of — — — 1 — 1 — — — — 1 — — — — — — — — — — VAMC Kansas City — — — 2 — — — — — — — — — — — — — — — — — Wayne State Univ 5 — — 7 — — — 1 — 1 1 — 1 — — 1 — — — — — Wichita NCORP — — — 19 — — — 1 3 7 — — — — — 13 — — — — — Wisconsin NCORP — — — 4 — — — — — 1 — — — — — — — — — — — Yale University — 11 — 20 — 1 1 — 1 18 — — 1 13 — — — — — 3 — Alliance — — — 290 12 12 10 8 35 17 8 — — — — — — — — — — CCTG — — — 8 — — — — — — — — — — — — — — — — — ECOG-ACRIN — — — 264 6 5 10 3 48 8 8 — — — — — — — — — — NRG — — — 144 6 5 6 2 16 7 2 — — — — — — — — — — Total 117 47 1 1,332 39 53 43 25 212 131 37 24 333 27 2 51 2 4 15 3 8

57 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Lymphoma Committee

Leadership Active Studies Chair: ...... Jonathan W . Friedberg, M .D . S1608, “Randomized Phase II Trial in High-Risk Relapsed Refractory Follicular Vice-Chair: ...... Sonali M . Smith, M .D . Lymphoma ”. Dr . Barr . Ac-tivated: 8/10/17 Executive Officer: ...... Susan M . O’Brien, M .D . CTSU/A051301, “A Randomized Double-Blind Phase III Study of Ibrutinib Statisticians: ...... Michael LeBlanc, Ph .D . During and Following Autologous Stem Cell Transplantation Versus ...... Hongli Li, M .S . Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Scientific Leadership Lymphoma of the Activated B-Cell Subtype ”. Dr . Stiff . Activated: 7/6/16 . Translational Medicine: ...... Lisa M . Rimsza, M .D . Radiation Oncology: ...... Louis S . Constine, M .D . CTSU/CALGB 501101, “A Randomized Phase II Trial of Myeloablative versus Imaging: ...... Oliver W . Press, M .D ., Ph .D . Non-Myeloablative Consoli-dation Chemotherapy for Newly Diagnosed ...... Lawrence H . Schwartz, M .D . Primary CNS B-Cell Lymphoma ”. Dr . Mohile . Activated: 6/15/12 . Pathology: ...... Lisa M . Rimsza, M .D . CTSU/EA4151, “A Randomized Phase III Trial of Consolidation with Early Therapeutics: ...... Daruka Mahadevan, M .D ., Ph .D . Autologous Hematopoietic Cell Transplantation Followed by Maintenance Designates Rituximab vs . Maintenance Rituximab Alone for Patients with Mantle Cancer Control: ...... TBD Cell Lymphoma in Minimal Residual Disease-Negative First Complete Data Coordinators: ...... Jeri Jardine Remission . Drs . Fenske, Till, Blum, Crump, Scott, and Kostakoglu . Activated: ...... Iris Syquia 8/29/17 Oncology Research Professionals: CTSU/EAY131, “Molecular Analysis for Therapy Choice (MATCH) ”. Activated: CRA: ...... Erin M . Cebula, M .P .H . 8/12/15 . Nurse: ...... TBD Patient Advocate: ...... Hildy Dillon, M .P .H . Closed Studies Pharmaceutical Science: ...... Lara M . Au, Pharm .D . S0801, “A Phase II Study of Iodine-131 Labeled Tositumomab in Combination ...... Craig Elg, Pharm .D . With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Protocol Coordinator: ...... Veronica Garcia Rituximab Therapy for Patients with Advanced Stage Follicular Non- Hodgkin’s Lymphoma” . Drs . Paul M . Barr, J W. . Friedberg, O W. . Press, and Time/Location L .M . Rimsza . Activated: 04/01/09 . Closed 12/15/2010 . Friday, October 13, 2017 4:00 p .m . - 7:00 p .m . Regency B, Ballroom Level, West Tower S1204, “A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) 1 . Open Studies: and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients ”. a . 51301: Dr . Stiff Drs . Ramsey, Loomba, Chugh, Hershman and Hwang . Activated: 8/29/13 . b . S1608: Dr . Barr Closed 02/15/2017 . c . EA4151: Dr . Till CTSU/E1411,” Intergroup Randomized Phase II Four Arm Study in Patients 2 . Studies in Development with Previously Untreated Mantle Cell Lymphoma of Therapy with: Arm A = Rituximab+Bendamustine Followed by Rituximab Consolidation a . T-cell lymphoma: Dr . Amengual (RB -->R); Arm B = Rituximab+Bendamustine+Bortezomib Followed by b . DLBCL: Dr . S . Smith Rituximab Consolidation (RBV--> R), Arm C = Rituximab+Bendamustine 3 . ASH presentations Followed by Lenalidomide+Rituximab Consolidation (RB --> LR) a . S1001 PET Data: Dr . Persky or Arm D = Rituximab+Bendamustine+Bortezomib Followed by Lenalidomide+Rituximab Consolidation (RBV --> LR) ”. Dr . Smith . Activated: b . S1001 Pathology Data: Dr . Stephens 5/22/12 . Closed: 9/09/16 4 . Monitoring Patients After Lymphoma Treatment: Dr . Phillips and Dr . S . Smith . CTSU/E1412, “Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs . RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, 5 . Elderly DLBCL Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Geriatric lymphoma: Dr . Supriya Mohile Large B Cell Lymphoma ”. Activated: 8/27/13 . Closed: 1/17/17.

58 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Lymphoma Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1001 A051301 C51101 E1411 E1412 E1412E1411 9177 Arizona MC, U of 7 — — 1 1 — Arkansas, U of — — — 1 — — Brooke Army Med Ctr — — — — 2 — CRC West MI NCORP — — — 3 — — Cincinnati MC, U of — — — — 3 — City of Hope Med Ctr 4 1 — — — — Cleveland Clinic OH — — — 9 — 4 Colorado, U of — — — 4 — — Columbia MU-NCORP — — — 1 3 — Davis, U of CA — — 1 — — — Dayton NCORP — — — 2 — — Essentia Hlth NCORP 1 — — — — — Fred Hutchinson CRC 2 — 2 4 — — Greenville NCORP 2 — — — — — Hawaii MU-NCORP 4 — — 4 1 — Kaiser Perm NCORP — — — 14 7 — Kansas City NCORP 6 — — 3 1 1 Kansas, U of — — 2 — — — Kentucky, U of 3 — — — — 4 Loyola University 5 — — — — — Michigan CRC NCORP 8 — — — — — Montana NCORP 1 — — 3 4 — Northwest NCORP 4 — — — — — Oregon Hlth Sci Univ — — — 6 — — PCRC NCORP 2 — — 3 — — Rochester, Univ of 28 — 3 25 16 9 Southeast COR NCORP 1 — — 1 — — Tennessee, U Tennessee, U of — — — — — 1 Tulane University — — 1 — — — Upstate Carolina 7 — — 1 — — Wayne State Univ — — — 1 1 — Wichita NCORP 6 — — — 1 — Yale University 6 — — — — — Alliance 40 — — — — — ECOG-ACRIN 20 — — — — — NRG 2 — — — — — Total 159 1 9 86 39 19

59 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Melanoma Committee “

Leadership Active Studies Chair: ...... Antoni Ribas, M .D ., Ph .D . Vice-Chair: ...... Kenneth F . Grossman, M .D ., Ph .D . S1320, “A Randomized Phase II Trial of Intermittent Versus Continuous Executive Officer: ...... Christopher W . Ryan, M .D . Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in Statisticians: ...... Michael Wu, Ph .D . BRAFV600E/K Mutant Melanoma ”. Dr . Algazi . Activated: 7/22/14 ...... Megan Othus, Ph .D . S1512, “A Phase II Study of PD-1 Blockade with Pembrolizumab in Patients ...... James Moon, M .S . with Locally Advanced and Metastatic Desmoplastic Melanoma (DM) ”...... Hongli Li, M .S . Drs . K . Kendra and S . Hu-Lieskovan . Activated: 10/20/16 ...... Michaella Latkovic-Taber, M .P .H . Scientific Leadership S1616, “A Phase II Randomized Study of Nivolumab (NSC-748726) with Translational Medicine: ...... William E . Carson, III, M .D . Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Radiation Oncology: ...... Evan J . Wuthrick, M .D . Patients Refractory to an Anti-PD-1 or Anti-PD-lL1 Agent ”. Drs . A . Surgery: ...... Robert H .I . Andtbacka, M .D . VanderWalde and T . Ribas . Activated 7/17/17 . Imaging: ...... Kenneth F . Grossman, M .D ., Ph .D . S1221, “Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor ...... Martin Allen-Auerbach, M .D . GSK2141795 in Combination with Dabrafenib and Trametinib in Patients Medical Oncology: ...... Lawrence E . Flaherty, M .D . with BRAF Mutant Cancer ”. Drs . A . Algazi and T . Ribas . Activated: 7/1/13 . Pathology: ...... TBD Temporarily closed: 10/31/16 . Non-Melanoma Skin Cancer: ...... Sancy A . Leachman, M .D ., Ph .D . Early Therapeutics: ...... Jeffrey A . Sosman, M .D . CTSU/EA6134, “A Randomized Phase III Trial of Dabrafenib + Trametinib SWOG’s ECOG Liaison: ...... Kenneth F . Grossmann, M .D ., Ph .D . Followed by Ipilimumab + Nivolumab at Progression vs . Ipilimumab ECOG’s SWOG Liaison: ...... David Lawson, M .D . + Nivolumab followed by Dabrafenib + Trametinib at Progression in ...... Andrew. Poklepovich, M .D . Patients with Advanced BRAFV600 Mutant Melanoma” . Dr . Chmielowski . Designates Activated: 7/13/15 . Cancer Control Liaison: ...... Sancy Leachman, M .D ., Ph .D . CTSU/EA6141, “Randomized Phase II/III Study of Nivolumab Plus Data Coordinator: ...... Diana Heaney Ipilimumab Plus Sargramostim versus Nivolumab Plus Ipilimumab in ...... Joanna Dur Patients with Unresectable Stage III or Stage IV Melanoma ”. Dr . Kim ...... Krystle Pagarigan Activated: 9/10/15 . Temporarily closed: 6/23/17 . Oncology Research Professionals: CRA: ...... Kacie L . Simpson, B .S ., C C. .R .P . Upcoming Studies Nurse: ...... Lisa S . Morgan, R .N ., O C. .N . S1607, “A Phase II Study of Combining T-VEC (NSC-785349) and Patient Advocate: ...... Valerie Guild, M .B .A . Pembrolizumab (NSC-776864) in Patients with Advanced Melanoma who Pharmaceutical Science: ...... Sun “Coco“ Yang, Pharm .D ., Ph .D . have Progressed on Anti-PD1/L1 Based Therapy ”. Dr . Hu-Lieskovan . Protocol Coordinator: ...... Danae Campos Follow Up on Recently Closed Studies

Time/Location S1404, “A Phase III Randomized Trial Comparing Physician/Patient Choice of Friday, October 13, 2017 9:30 a .m . - 11:30 a .m . either High-Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) Crystal B, Lobby Level, West Tower in Patients with High-Risk Resected Melanoma ”. Drs . Grossmann and Patel . Activated 10/15/15 . Closed: 8/15/17 . 9:30-11:30 a.m.: Presentation of ongoing SWOG melanoma committee clinical trials

60 SWOG Leading cancer research. Together.

CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 With support from Hope, advocates are working“ “ with SWOG to improve the quality of life for patients, both during and after treatment. Helping Advocates Do More SWOG advocates serve as the voice of the patient in clinical trials – from the original concept to final publication. Help The Hope Foundation continue its support of their invaluable efforts. Jack Aiello, MS, EE TextSWOG “SWOG” Patient to 41444 toAdvocate, give today. Myeloma Committee 25 Years of Supporting SWOG

Amy Geschwender, PhD SWOG Patient Advocate, Symptom Control & Quality of Life Committee

61 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Melanoma Committee Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1221 S1320 S1404 S1512 E3612 EA6134 EA6141 Arizona MC, U of — 2 10 — — — — Arkansas, U of — 5 11 — — 1 — Baylor Univ Med Ctr — — 12 — — — — Boston Medical Ctr — 1 — — — — — CORA NCORP — 1 8 — — — — CRC West MI NCORP — 2 13 — — — — Cedars-Sinai Med Ctr — — 7 — — — — Cincinnati MC, U of — — 3 — — — — City of Hope Med Ctr — — 8 — — 1 3 Cleveland Clinic OH — — 23 — — — — Colorado, U of 5 2 29 — — 1 — Columbia MU-NCORP — — 3 — — — — Columbus NCORP — — 4 — — — — Davis, U of CA — — 2 — — — — Dayton NCORP — 1 7 — — — — Essentia Hlth NCORP — — 1 — — — — Georgia NCORP — — 17 — — — — Greenville NCORP — — — — 1 — — Gulf South MU-NCORP — — 3 — — — — H Lee Moffitt CC — — 48 — — — — Hawaii MU-NCORP — 1 3 — — — — Heartland NCORP — 5 24 — — — — Irvine, U of CA — — 1 — — — — Kaiser Perm NCORP — 24 68 — 3 2 20 Kansas City NCORP — — 1 — — — 1 Kansas, U of — 12 24 — — 2 — Lahey Hosp & Med Ctr — 1 4 — — — — Los Angeles, U of CA 6 2 22 — — 3 — Loyola University — 4 1 — — — — MD Anderson CC — — 40 — — — — Michigan CRC NCORP — — 8 — — — —

62 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017

Melanoma Committee, cont. Cumulative Accrual by Institution and Study For the Period Ending July 30, 2017 | Includes studies that are currently open, or that closed since Jan. 1, 2016.

S1221 S1320 S1404 S1512 E3612 EA6134 EA6141 Michigan, U of 5 3 12 — — — — Mississippi, Univ of — — 1 — — — — Montana NCORP — — 4 — — — — Mt Sinai Med Ctr — — 10 — — — — Nevada CRF NCORP — 2 — — — — — New Mexico MU-NCORP — — 8 — — — — Northwest NCORP — — 9 — — — — Northwestern Univ — — 13 — 1 — — Ohio State Univ 6 9 31 1 — 2 — Oregon Hlth Sci Univ — — 10 — — — — Ozarks NCORP — 2 4 — — — — PCRC NCORP 2 2 16 — — — — Rochester, Univ of — 3 6 — — — — San Antonio, U of TX — — 7 — — — 1 San Diego, U of CA — — 6 — — — — San Francisco, U-CA 1 8 — — — — — So Calif, U of — — — 1 — — — Southeast COR NCORP — 5 9 — — — — Sutter Cancer RC 2 — 5 — — 2 5 Tennessee, U of — — 4 — — — — Utah, U of — 6 30 — — — — VAMC Kansas City — — 1 — — — — Wayne State Univ — — 9 — — 2 — Wichita NCORP — 4 11 — — — — Wisconsin NCORP — — 6 — — — — Yale University — — 5 — — — 6 Alliance — 12 136 — — — — CCTG — — 107 — — — — ECOG-ACRIN — 38 260 — — — — NRG — 7 86 — — — — Total 27 164 1,211 2 5 16 36

63 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Publication List by Committee

The publications listed below were received by the group chair’s office as published, accepted, and submitted or reflect change in publication status since the SWOG 2017 Spring Group Meeting . Not included are submitted or accepted publications where posting is not permitted due to journal embargo policy (e g. ., NEJM) . Conference abstracts are also not included .

Adolescent and Young Adult (AYA) Committee Anderson, GE Goodman, PH Brown, FL Meyskens, KS Albain NPJ Breast Cancer , 2016 Aug 10;2:16024 . [see also Prevention & Epidemiology Cmte] Published/Accepted Manuscripts https://www ncbi. nlm. nih. gov/pubmed/28721383. Practice makes perfect: The rest of the story in testicular cancer as a model S9630/Multiple Studies How do we increase uptake of tamoxifen and curable neoplasm . T Tandstad, C Kollmannsberger, B Roth, C Jeldres, S other anti-estrogens for breast cancer prevention? KD Crew, KS Albain, Gillessen, K Fizazi, S Daneshmand, W Lowrance, N Hanna, C Albany, R DL Hershman, JM Unger, SS Lo . NPJ Breast Cancer, May 19;3:20, 2017 . Foster, G Cohn-Cedermark, D Feldman, T Powles, M Lewis, P Grimison, D [commentary] [see also Prevention & Epidemiology Cmte] https://www . Bank, C Porter, P Albers, M De Santis, S Srinvas, G Bosl, C Nichols . Journal ncbi nlm. nih. gov/pubmed/28649660. of Clinical Oncology, 2017 Aug 30 [Epub ahead of print] . https://www . ncbi nlm. nih. gov/pubmed/28854068. JMA27 Lipton A, Chapman JW, Leitzel K, Garg A, Pritchard K, Ingle J, Budd G, Ellis M, Sledge G, Rabaglio M, Han L, Elliott C, Shepherd LE, Goss Submitted Manuscripts PE, Ali S . Osteoporosis therapy prolongs event-free survival in post- No publication information for this cycle . menopausal breast cancer patients randomized to adjuvant exemestane or anastrozole: NCIC CTG MA .27 . Cancer Jul 1;123(13):2444-2451, 2017 . Barlogie-Salmon Myeloma Committee https://www ncbi. nlm. nih. gov/pubmed/28464211.

Published/Accepted Manuscripts CCTG MA32 Lohmann AE, Liebman MF, Brien W, Parulekar WR, Gelmon S0777/other Proteasome inhibitors in cancer therapy . EE Manasanch, RZ KA, Shepherd LE, Ligibel J, Hershman DL, Rastogi P, Mayer IA, Hobday Orlowski . Nature Reviews Clinical Oncology Jul;14(7):417-433, 2017 . TJ, Lemieux J, Thompson AM, Pritchard KI, Whelan TJ, Mukherjee S, https://www ncbi. nlm. nih. gov/pubmed/28117417. Chalchal HI, Bernstein V, Stambolic V, Chen BE, Goodwin PJ . Effects of metformin versus placebo on vitamin B12 metabolism in non-diabetic Submitted Manuscripts breast cancer patients in CCTG MA .32 . Breast Cancer Research and No publication information for this cycle . Treatment Jul;164(2):371-378, 2017 . https://www .ncbi .nlm .nih gov/. pubmed/28447237 Breast Committee Z1071 Tumor biology and response to chemotherapy impact breast Published/Accepted Manuscripts cancer-specific survival in node-positive breast cancer patients treated with neoadjuvant chemotherapy: long-term follow-up from ACOSOG S0221 Supplement use and chemotherapy-induced peripheral neuropathy Z1071 (Alliance) . JC Boughey, KV Ballman, LM McCall, EA Mittendorf, WF in patients treated in a SWOG cooperative group trial (S0221): the Symmans , TB Julian, D Byrd, KK Hunt . Annals of Surgery Jun 27 [Epub DELCaP Study . G Zirpoli, S McCann, L Sucheston-Campbell, D Hershman, ahead of print], 2017 . https://www .ncbi .nlm .nih gov/pubmed/28657941. G Ciupak, W Davis, J Unger, H Moore, JA Stewart, C Isaacs, T Hobday, M Salim, R Livingston, G Hortobagyi, J Gralow, D Hayes, G Budd, K Albain, C Submitted Manuscripts Ambrosone . Journal of the National Cancer Institute, in press . [see also S0800 Effects of neoadjuvant chemotherapy on tumor infiltrating SCQOLCmte] lymphocytes and PD-L1 expression in the SWOG S0800 clinical trial S9630 A Phase III randomized comparison of medroxyprogesterone V Pelekanou, WE Barlow, ZA Nahleh, B Wasserman, Y-C Lo, M-K von acetate versus observation for the prevention of endometrial pathology Wahlde, D Hayes, GN Hortobagyi, J Gralow, D Tripathy, P Porter, RB in postmenopausal patients with breast cancer treated with adjuvant Livingston, B Szekely, C Hatzis, DL Rimm, L Pusztai . JAMA Oncology, tamoxifen: SWOG S9630 . RK Potkul, JM Unger, RB Livingston, S under review . Wilczynski, C Salomon, B Smith, L Wong, DL Campbell, SJ Vogel, GL

64 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Publication List by Committee

S9313 Impact of homologous recombination deficiency biomarkers on Goodman, LM Minasian, DL Hershman . JCO Clinical Cancer Informatics, outcomes in patients with triple-negative breast cancer treated with under review . doxorubicin-based adjuvant chemotherapy (SWOG S9313) . P Sharma, S9217 Long term risk of prostate cancer on the Prostate Cancer Prevention WE Barlow, AK Godwin, H Pathak, K Isakova, KM Timms, AR Hartman, RJ Trial (SWOG S9217) . JM Unger, DL Hershman, C Till, CM Tangen, WE Wenstrup, HM Linden, D Tripathy, GN Hortobagyi, DF Hayes . Journal of Barlow, SD Ramsey, PJ Goodman, IM Thompson, Jr . JAMA Oncology, Clinical Oncology, under review . under review .

Cancer Control & Prevention Multiple Studies* Survival by Hispanic ethnicity among SWOG cancer clinical trials patients . M Chavez-MacGregor, JM Unger, A Moseley, S Cancer Care Delivery Committee Ramsey, DL Hershman . Cancer Epidemiology Biomarkers and Prevention, Published/Accepted Manuscripts under review . [*studies: S8516, S8600, S8809, S8814, S8894, S8897, S8905, S9008, S9031, S9125, S9210, S9240, S9304, S9308, S9313, S9321, S1415CD A stakeholder-informed randomized, controlled comparative S9333, S9346, S9349, S9415, S9420, S9509, S9623, S9704, S9800, S9911, effectiveness study of an order prescribing intervention to improve S9916, S0003, S0012, S0016, S0033, S0106, S0221, S0226, S0232, S0307, colony stimulating factor use for cancer patients receiving S0421, S0500] . myelosuppressive chemotherapy: The TrACER study . A Bansal, SD Sullivan, DL Hershman, GH . Lyman, WE Barlow, JS McCune, SD Ramsey . Multiple Studies* History of diabetes and outcome among participants Journal of Comparative Effectiveness Research, Journal of Comparative 65 or older in SWOG clinical trials . DL Hershman, C Till, JD Wright, S Effectiveness Research, 2017 Jul;6(5):461-470 . https://www .ncbi .nlm .nih . Ramsey, W Barlow, J Unger . JCO Clinical Cancer Informatics, revised/ gov/pubmed/28686055 resubmitted . [*studies: S0003, S0023, S0033, S0124, S0205, S0221, S0226, S0232, S0307, S0421, S0500, S0777, S9321, S9346, S9916] . Multiple Studies* The effect of positive SWOG treatment trials on survival of patients with cancer in the US population . JM Unger, M LeBlanc, CD Cancer Survivorship Committee Blanke . JAMA Oncology, 2017 Jun 5 . doi: 10 1001/jamaoncol. .2017 .0762 . [*studies: SWG01, SWG02, S7436, S7704, S7817, S8494, S8501, S8591, Published/Accepted Manuscripts S8624, S8710, S8736,S8797, S8814, S8892, S8897, S8949, S9008, C89803 Predicted vitamin D status and colon cancer recurrence and S9126,S9210, S9308, S9916, S0226, S0777] . https://www .ncbi .nlm .nih gov/. mortality in CALGB 89803 (Alliance) . MA Fuchs, C . Yuan, K Sato, pubmed/28586789 D Niedzwiecki, X Ye, LB Saltz, RJ Mayer, RB Mowat, R Whittom, A Hantel, A Benson, D Atienza, M Messino, H Kindler, A Venook, F Characterizing 18 years of death with dignity in Oregon . C Blanke, M Innocenti, RS Warren, MM Bertagnolli, S Ogino, EL Giovannucci, E LeBlanc, D Hershman, L Ellis, F Meyskens . JAMA Oncology, 2017 Apr 6 Horvath, JA Meyerhardt, K Ng . Annals of Oncology Jun 1;28(6):1359- [Epub ahead of print] . https://www .ncbi .nlm .nih gov/pubmed/28384683. 1367, 2017 . [see also GI Cmte] https://www .ncbi .nlm .nih gov/. Feasibility of a centralized clinical trials coverage analysis: a joint initiative pubmed/?term=hantel+a+vitamin+d of the American Society for Clinical Oncology (ASCO) and the Submitted Manuscripts National Cancer Institute (NCI) . CM Szczepanek, P Hurley, MJ Good, A Denicoff, K Willenberg, C Dawson, D Kurbegov . Journal of Oncology S0424 Smoking, sex and non-small cell lung cancer: examination of steroid Practice, Jun;13(6):395-400, 201 . https://www .ncbi .nlm .nih gov/. hormone receptors in lung tumor tissue in SWOG S0424 . T-Y D Cheng, pubmed/28481681 AK Darke, MW Redman, GR Zirpoli, W Davis, R Payne Ondracek, W Bshara, A Omilian, R Kratzke, ME Reid, JR Molina, JM Kolesar, Y Chen, RM Responding to patient requests for hastened death: physician aid in dying MacRae, J Moon, P Mack, DR Gandara, K Kelly, RM Santella, KS Albain, CB and the clinical oncologist . RA Spence, CD Blanke, TJ Keating, et al . Ambrosone . Journal of the National Cancer Institute, pending revision/ Journal of Oncology Practice, in press . resubmission . [see also Lung Cmte] Submitted Manuscripts A011401 Randomized Phase iii trial evaluating the role of weight loss S0000/S9217 The scientific impact and value of large, NCI-sponsored in adjuvant treatment of overweight and obese women with early randomized Phase III cancer prevention trials . JM Unger, WE Barlow, CM breast cancer (A011401): study design and rationale . JA Ligibel, WT Tangen, SD Ramsey, IM Thompson, Jr ., EA Klein, M LeBlanc, CD Blanke, PJ Barry, C Alfano, DL Hershman, M Irwin, ML Neuhouser, CA Thomson,

65 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Publication List by Committee

LM Delahanty, E Frank, P Spears, ED Paskett, JO Hopkins, V Bernstein, V S9217 Association between variants in genes involved in the immune Stearns, J White, C Hudis, EP Winer, TA Wadden, PJ Goodwin . NPJ Breast response and prostate cancer risk in men randomized to the finasteride Cancer, under review . arm in the Prostate Cancer Prevention Trial . D Winchester, C Till, PJ Goodman, CM Tangen, RM Santella, TL Johnson-Pais, RJ Leach, J Xu, SL C89803 Long-chain omega-3 fatty acid and fish intake after colon cancer Zheng, IM Thompson, MS Lucia, SM Lippman, HL Parnes, WB Isaacs, AM diagnosis in relation to cancer recurrence and survival . E Van Blarigan, C De Marzo, CG Drake, EA Platz . Prostate Jun;77(8):908-919, 2017 . https:// Fuchs, D Niedzwiecki, X Ye, S Zhang, M Song, L Saltz, R Mayer, R Mowat, R www .ncbi .nlm .nih gov/pubmed/28317149. Whittom, A Hantel, A Benson, D Atienza, M Messino, H Kindler, A Venook, S Ogino, E Giovannucci, J Meyerhardt . Cancer Epidemiology, Biomarkers S9217/Multiple Studies A pooled analysis of 15 prospective cohort & Prevention, submitted . [see also GI Cmte] studies on the association between fruit, vegetable, and mature bean consumption and risk of prostate cancer . J Petimar, KM Wilson, K Wu, C89803 Artificially sweetened beverage intake and outcome in stage iii D Albanes, PA van den Brandt, MB Cook, GG Giles, E Giovannucci, GG colon cancer: results from CALGB 89803 (Alliance) . C Fuchs, B Guercio, Goodman, PJ Goodman, N Håkansson, K Helzlsouer, LN Kolonel, LM Liao, S Zhang, D Niedzwiecki, Z Yee, Y Li, A Babic, V Morales-Oyarvide, L S Männistö, ML McCullough, R Milne, ML Neuhouser, Y Park, EA Platz, N Saltz , RJ Mayer, R Mowat, R Whittom, A Hantel, A Benson, DM Atienza, Sawada, JM Schenk, S Tsugane, B Verhage, M Wang, Y Wang, LR Wilkens, M Messino, H Kindler, A Venook, S Ogino, E Zoltick, M Stempfer, K A Wolk, RG Ziegler, SA Smith-Warner . Cancer Epidemiology Biomarkers Ng, K Wu, W Willett, E Giovannucci, J Meyerhardt . Journal of Clinical & Prevention Aug;26(8):1276-1287, 2017 . https://www .ncbi .nlm .nih .gov/ Oncology, submitted . [see also GI Cmte] pubmed/28446545

Prevention & Epidemiology Committee S9630 A Phase III randomized comparison of medroxyprogesterone Published/Accepted Manuscripts acetate versus observation for the prevention of endometrial pathology in postmenopausal patients with breast cancer treated with adjuvant S0000A Association of antioxidant supplement use and dementia in tamoxifen: SWOG S9630 . RK Potkul, JM Unger, RB Livingston, S The Prevention of Alzheimer’s Disease by Vitamin E and Selenium Trial Wilczynski, C Salomon, B Smith, L Wong, DL Campbell, SJ Vogel, GL (PREADViSE) . RJ Kryscio, EL Abner, A Caban-Holt, M Lovell, P Goodman, J Anderson, GE Goodman, PH Brown, FL Meyskens, KS Albain NPJ Breast Hartline, AK Darke, M Yee, J Crowley, FA Schmitt . JAMA Neurology May Cancer , 2016 Aug 10;2:16024 . [see also Breast Cmte] https://www .ncbi . 1;74(5):567-573, 2017 . https://www .ncbi .nlm .nih gov/pubmed/28319243. nlm nih. gov/pubmed/28721383.

S0000_S9217 A prospective study of chronic inflammation in benign S9630/Multiple Studies How do we increase uptake of tamoxifen prostate tissue and risk of prostate cancer: linked PCPT and SELECT and other anti-estrogens for breast cancer prevention? KD Crew, cohorts . E Platz, I Kulac, J Barber, C Drake, C Joshu, W Nelson, MS Lucia, KS Albain, DL Hershman, JM Unger, SS Lo . NPJ Breast Cancer, May EA Klein, SM Lippman, H Parnes, IM Thompson, P Goodman, C Tangen, 19;3:20, 2017 . [also under Breast Cmte] https://www .ncbi .nlm .nih gov/. AM De Marzo . Cancer Epidemiology, Biomarkers and Prevention, 2017 pubmed/28649660 Jul 28 . pii: cebp .0503 .2017 [Epub ahead of print] . https://www .ncbi .nlm . nih gov/pubmed/28754796. Submitted Manuscripts

S0820 Updates on S0820/PACES: Preventing adenomas of the colon with S9217 Associations between genetic polymorphisms in genes related to eflornithine and sulindac . J Zell, R Krouse, N You . Bulletin of the American estrogen metabolism and function and prostate cancer risk: results from College of Surgeons, in press . the Prostate Cancer Prevention Trial . L Tang, ME Platek, S Yao, C Till, PJ Goodman, CM Tangen, Y Wu, EA Platz, ML Neuhouser, FZ Stanczyk, JKV S9217 Interactions of the insulin-like growth factor axis and vitamin D in Reichardt, RM Santella, A Hsing, WD Figg, SM Lippman, IM Thompson, prostate cancer risk in the Prostate Cancer Prevention Trial . FL Miles, CB Ambrosone . Carcinogenesis, submitted . PJ Goodman, C Tangen, KC Torkko, JM Schenk, X Song, M Pollak, IM Thompson, ML Neuhouser . Nutrients 2017 Apr 12;9(4) . pii: E378 . doi: 10 .3390/nu9040378 . https://www .ncbi .nlm .nih gov/pubmed/28417914.

66 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Publication List by Committee

Symptom Control & Quality of Life Committee bevacizumab in advanced, poor prognosis carcinoid patients: SWOG S0518 . JC Yao, KA Guthrie, C Moran, JR Strosberg, MH Kulke, J Ang Chan, Published/Accepted Manuscripts N Loconte, RR McWilliams, EM Wolin, B Mattar, S McDonough, H Chen, S0221 Supplement use and chemotherapy-induced peripheral neuropathy CD Blanke, HS Hochster . Journal of Clinical Oncology May 20;35(15):1695- in patients treated in a SWOG cooperative group trial (S0221): the 1703, 2017 . https://www .ncbi .nlm .nih gov/pubmed/28384065. DELCaP Study . G Zirpoli, S McCann, L Sucheston-Campbell, D Hershman, CALGB/SWOG 80405 Effect of first-line chemotherapy combined with G Ciupak, W Davis, J Unger, H Moore, JA Stewart, C Isaacs, T Hobday, M cetuximab or bevacizumab on overall survival in patients with KRAS Salim, R Livingston, G Hortobagyi, J Gralow, D Hayes, G Budd, K Albain, C wild-type advanced or metastatic colorectal cancer: A randomized trial . Ambrosone . Journal of the National Cancer Institute, in press . [see also AP Venook, D Niedzwiecki, H-J Lenz, F Innocenti, B Fruth, JA Meyerhardt, Breast Cmte] D Schrag, C Greene, BH O’Neil, JE Shaw, JN Atkins, A El-Khoueiry, S S0702 Dental health status and patient- reported outcomes at baseline Berry, BN Polite, EM O’Reilly, RM Goldberg, HS Hochster, RL Schilsky, in patients participating in the osteonecrosis of the jaw registry study, MM Bertagnolli, RJ Mayer, CD Blanke . Journal of the American Medical SWOG S0702 . CH Van Poznak, A Darke, CM Moinpour, RA Bagramian, Association Jun 20;317(23):2392-2401, 2017 . https://www .ncbi .nlm .nih . MM Schubert, JR Gralow, JL Wade, III, JM Unger . Supportive Care in gov/pubmed/28632865 Cancer, Apr;25(4):1191-1199, 2017 . https://www .ncbi .nlm .nih gov/. C89803 Predicted vitamin D status and colon cancer recurrence pubmed/27928641 and mortality in CALGB 89803 (Alliance) . MA Fuchs, C . Yuan, K Sato, Submitted Manuscripts D Niedzwiecki, X Ye, LB Saltz, RJ Mayer, RB Mowat, R Whittom, A Hantel, A Benson, D Atienza, M Messino, H Kindler, A Venook, F S0715 Two-year trends of taxane-induced neuropathy in women enrolled Innocenti, RS Warren, MM Bertagnolli, S Ogino, EL Giovannucci, E in a randomized trial of acetyl-l-carnitine (SWOG S0715) . DL Hershman, Horvath, JA Meyerhardt, K Ng . Annals of Oncology Jun 1;28(6):1359- JM Unger, KD Crew, C Till, H Greenlee, LM Minasian, CM Moinpour, DL 1367, 2017 . [see also Ca Surv Cmte] https://www .ncbi .nlm .nih gov/. Lew, L Fehrenbacher, JL Wade, S-F Wong, MJ Fisch, NL Henry, KS Albain . pubmed/?term=hantel+a+vitamin+d Journal of the National Cancer Institute, pending revision/resubmission . Submitted Manuscripts S1202 Randomized multicenter placebo-controlled clinical trial of duloxetine versus placebo for aromatase inhibitor-associated arthralgias C89803 Artificially sweetened beverage intake and outcome in stage iii in early stage breast cancer: SWOG S1202 . NL Henry, JM Unger, AF colon cancer: results from CALGB 89803 (Alliance) . C Fuchs, B Guercio, Schott, L Fehrenbacher, PJ Flynn, DM Prow, CW Sharer, G Von Burton, CS S Zhang, D Niedzwiecki, Z Yee, Y Li, A Babic, V Morales-Oyarvide, L Kuzma, A Moseley, DL Lew, M Fisch, C Moinpour, DL Hershman, JL Wade, Saltz , RJ Mayer, R Mowat, R Whittom, A Hantel, A Benson, DM Atienza, III . Journal of Clinical Oncology, under review . M Messino, H Kindler, A Venook, S Ogino, E Zoltick, M Stempfer, K Ng, K Wu, W Willett, E Giovannucci, J Meyerhardt . Journal of Clinical N0147 Cetuximab reduces patient quality of life when administered with Oncology, submitted . [see also Ca Surv Cmte] mFOLFOX6 as adjuvant treatment following complete resection of KRAS wild-type tumors for stage III colorectal cancer (N0147 Alliance) . MR C89803 Long-chain omega-3 fatty acid and fish intake after colon cancer Mahoney, JA Sloan, JM Hubbard, AD Tan, H Liu, RM Goldberg, SG Nair, AF diagnosis in relation to cancer recurrence and survival . E Van Blarigan, C Shields, S Gill, B Jahagirdar, AB Benson, DJ Sargent, SR Alberts . Journal of Fuchs, D Niedzwiecki, X Ye, S Zhang, M Song, L Saltz, R Mayer, R Mowat, R Patient-Reported Outcomes , under review . [see also GI Cmte] Whittom, A Hantel, A Benson, D Atienza, M Messino, H Kindler, A Venook, S Ogino, E Giovannucci, J Meyerhardt . Cancer Epidemiology, Biomarkers Early Therapeutics & Rare Cancers Committee & Prevention, submitted . [see also Ca Surv Cmte]

No publication information for this cycle . N0147 Cetuximab reduces patient quality of life when administered with mFOLFOX6 as adjuvant treatment following complete resection of KRAS Gastrointestinal Committee wild-type tumors for stage III colorectal cancer (N0147 Alliance) . MR Published/Accepted Manuscripts Mahoney, JA Sloan, JM Hubbard, AD Tan, H Liu, RM Goldberg, SG Nair, AF Shields, S Gill, B Jahagirdar, AB Benson, DJ Sargent, SR Alberts . Journal of S0518 Phase III prospective randomized comparison trial of depot Patient-Reported Outcomes , under review . [see also SXCQOL Cmte] octreotide plus interferon alpha-2b versus depot octreotide plus

67 SWOG Leading cancer research. Together. CHICAGO, ILLINOIS | OCTOBER 11-14, 2017 Publication List by Committee

Genitourinary Committee S1107 Parallel (randomized) Phase ii evaluation of tivantinib (arq197) and tivantinib in combination with erlotinib in papillary renal cell carcinoma: Note: All PCPT and SELECT publications are listed under SWOG S1107 . PW Twardowski, CM Tangen, X Wu, MR Plets, ER Plimack, N Cancer Control & Prevention Committees Agarwal, NJ Vogelzang, J Wang, S Tao, IM Thompson, Jr, P Lara Jr . Clinical Published/Accepted Manuscripts Cancer Research, under review .

S0421 Validation of the association of RECIST changes with survival in men E3805 Quality of life (QOL) during treatment with chemohormonal with metastatic castration resistant prostate cancer treated on SWOG therapy: analysis of ECOG 3805 chemohormonal androgen ablation study S0421 . G Sonpavde, GR Pond, M Plets, CM Tangen, MHA Hussain, randomized trial in prostate cancer (CHAARTED) . A Morgans, Y Chen, PN Lara, Jr, A Goldkorn, MG Garzotto, PC Mack, CS Higano, NJ Vogelzang, C Sweeney, D Jarrard, E Plimack, B Gartrell, M Carducci, M Hussain J . IM Thompson, Jr, PW Twardowski, PJ Van Veldhuizen, Jr, N Agarwal, MA Garcia, D Cella, R DiPaola, L Patrick-Miller . Journal of Clinical Oncology, Carducci, J Monk, DI Quinn . Clinical Genitourinary Cancer, 2017 May 10 submitted . [see also SXCQOL Cmte] [Epub ahead of print] . https://www .ncbi .nlm .nih gov/pubmed/28579151. E3805 Chemohormonal therapy in metastatic hormone-sensitive S1014 Abiraterone acetate for metastatic prostate cancer in patients prostate cancer: long-term survival analysis of the randomized Phase III with suboptimal biochemical response to hormone induction TW E3805 Trial . CE Kyriakopoulos, Y-H Chen, M Carducci, G Liu, DF Jarrard, Flaig, M Plets, M Hussain, N Agarwal, N Mitsiades, HA Deshpande, U M Eisenberger, Y Wong, N Hahn, M Kohli, MM Cooney, R Dreicer, NJ Vaishampayan, IM Thompson . JAMA Oncology 2017 Mar 30 [Epub Vogelzang, J Picus, D Shevrin, M Hussain, JA Garcia, RS DiPaola, CJ ahead of print] . https://www .ncbi .nlm .nih gov/pubmed/28358937. Sweeney . Journal of Clinical Oncology, submitted . E2805 Retroperitoneal lymphadenectomy in high-risk non-metastatic Leukemia Committee renal cell carcinoma: an analysis of the ASSURE (ECOG 2805) Adjuvant Trial . BT Ristau, J Manola, NB Haas, DY Heng, EM Messing, CG Wood, CJ Published/Accepted Manuscripts Kane, RS DiPaola, RG Uzzo . Journal of Urology 2017 Jul 17 [Epub ahead S1117 A randomized Phase II study of azacitidine alone or in combination of print] . https://www .ncbi .nlm .nih gov/pubmed/28728992. with lenalidomide or with vorinostat vs . azacitidine monotherapy Submitted Manuscripts in higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia CMML): North American Intergroup Study S0337 Immediate post TURBT instillation of gemcitabine vs saline for SWOG S1117 . MA Sekeres, M Othus, A List, O Odenike, R Stone, SD Gore, suspected low grade bladder cancer: SWOG S0337 . EM Messing, CM M Litzow, R Buckstein, M Fang, D Roulston, C Bloomfield, A Moseley, Tangen, SP Lerner, DM Sahasrabudhe, TM Koppie, DP Wood, Jr, PC Y Zhang, M . Velasco, R Gaur, E Atallah, EC Attar, F Appelbaum, H Erba . Mack, RS Svatek, CP Evans, KS Hafez, DJ Culkin, TC Brand, LI Karsh, JM Journal of Clinical Oncology Aug 20;35(24): 2745-2753, 2017 . https:// Holzbeierlein, SS Wilson, G Wu, M Plets, NJ Vogelzang, IM Thompson, Jr . www ncbi. nlm. nih. gov/pubmed/28486043. JAMA, submitted . C10603 Midostaurin plus chemotherapy for acute myeloid leukemia with S0421 Bone turnover biomarkers identify unique prognostic risk groups in a FLT3 mutation . RM Stone, SJ Mandrekar , BL Sanford, K Laumann, S men with castration resistant prostate cancer and skeletal metastases: Geyer, CD Bloomfield, C Thiede, TW Prior, K Döhner , G Marcucci, F Lo- results from SWOG S0421 . PN Lara, Jr ., M Plets, C Tangen, E Gertz, NJ Coco, RB Klisovic, A Wei, J Sierra, MA Sanz, JM Brandwein, T de Witte, D Vogelzang, M Hussain, PW Twardowski, MG Garzotto, JP Monk, M Niederwieser, FR Appelbaum, BC Medeiros, MS Tallman , J Krauter, RF Carducci, A Goldkorn, PC Mack, DI Quinn, IM Thompson, M Van Loan . Schlenk, A Ganser, H Serve, G Ehninger, S Amadori, RA Larson, H Döhner . Clinical Cancer Research, submitted . New England Journal of Medicine Aug 3;377(5):454-464, 2017 . https:// S0925 Circulating microRNAs and treatment response in SWOG S0925, www .ncbi .nlm .nih gov/pubmed/28644114. a randomized Phase II study of androgen deprivation combined with Submitted Manuscripts cixutumumab versus androgen deprivation alone for patients with new metastatic hormone-sensitive prostate cancer . HH Cheng, M Plets, S0106_E1900 Higher clinical trial accrual volume improves outcomes in H Li, CS Higano, CM Tangen, N Agarwal, NJ Vogelzang, M Hussain, IM acute myeloid leukemia: A SWOG/ECOG-ACRIN Study . BC Medeiros, Thompson, Jr ., M Tewari, EY Yu . Prostate, revised/resubmitted . M Othus, MS Tallman, Z Sun, HF Fernandez, JM Rowe, HM Lazarus, FR Appelbaum, SM Luger, MR Litzow, HP Erba . Haematologica, submitted

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S0919 Report of the relapsed/ refractory cohort of SWOG S0919: a Phase Multiple Studies*/Other A pooled analysis of individual patient data of 2 study of idarubicin and cytarabine in combination with pravastatin concurrent chemoradiotherapy for stage 3 non-small-cell lung cancer for acute myelogenous leukemia . AS Advani, Hongli Li, LC Michaelis, in elderly patients compared to younger patients who participated in BC Medeiros, M Liedtke, AF List, K O’Dwyer, M Othus, HP Erba, FR United States National Cancer Institute Cooperative Group studies . TE Appelbaum . Blood Advances, submitted . Stinchcombe, Y Zhang, EE Vokes, J Schiller, JD Bradley, Karen Kelly, W Curran, SE Schild, B Movsas, G Clamon, R Govindan, GR Blumenschein, S1612 Intergroup LEAP trial (S1612): a randomized rolling-arms platform MA Socinski, NE Ready, WL Akerley, HJ Cohen, H Pang, X Wang . Journal to test therapeutics in less-fit older adults with AML . RB Walter, LC of Clinical Oncology, Sep 1;35(25):2885-2892, 2017 . https://www .ncbi . Michaelis, M Othus, GL Uy, JP Radich, RF Little, S Hita, L Saini, JM Foran, nlm nih. gov/pubmed/28493811. AT Gerds, HD Klepin, AE Hay, JE Lancet, S Couban, MR Litzow, RM Stone, HP Erba . Blood, under review . Submitted Manuscripts

Multiple Studies* Impact of specimen heterogeneity on biomarkers in S0424 Smoking, sex and non-small cell lung cancer: examination of steroid repository samples from patients with AML: a SWOG report . E Pogosova- hormone receptors in lung tumor tissue in SWOG S0424 . T-Y D Cheng, Agadjanyan, A Moseley, M Othus, FR Appelbaum, T Chauncey, I-M L AK Darke, MW Redman, GR Zirpoli, W Davis, R Payne Ondracek, W Chen, HP Erba, JE Godwin, M Fang, K Kopecky, AF List, GL Pogosov, JP Bshara, A Omilian, R Kratzke, ME Reid, JR Molina, JM Kolesar, Y Chen, RM Radich, CL Willman, BL Wood, S Meshinchi, DL Stirewalt . Biopreservation MacRae, J Moon, P Mack, DR Gandara, K Kelly, RM Santella, KS Albain, CB and Biobanking, submitted . [*studies:S9031, S9333, S0106, S0112] Ambrosone . Journal of the National Cancer Institute, pending revision/ resubmission . [see also Ca Surv Cmte] Lung Committee E1505 Randomized Phase III trial of adjuvant chemotherapy with or Published/Accepted Manuscripts without bevacizumab in resected non-small cell lung cancer (NSCLC): results of E1505 . H Wakelee, S Dahlberg, S Keller, W Tester, D Gandara, S0635_S0636 Paired Phase II studies of erlotinib/bevacizumab in S Graziano, A Adjei, N Leighl, S Aisner, J Rothman, J Patel, MD Sborov, advanced bronchioloalveolar carcinoma or in never-smokers with S McDermott, R Perez-Soler, A Traynor, C Butts, T Evans, L Horn, SS advanced non-small-cell lung cancer (NSCLC): SWOG S0635 and S0636 Ramalingam, J Schiller on behalf of ECOG-ACRIN . Lancet Oncology, Trials . HL West, J Moon, AJ Wozniak, P Mack, FR Hirsch, MJ Bury, M pending revision/submission . Kwong, DD Nguyen, DF Moore, J Miao, M Redman, K Kelly, DR Gandara . Clinical Lung Cancer, Jul 6 [Epub ahead of print], 2017 . https://www .ncbi . Lymphoma Committee nlm nih. gov/pubmed/28801183. Published/Accepted Manuscripts S0819 A randomized, Phase iii study of carboplatin/paclitaxel or carboplatin/paclitaxel/ bevacizumab with or without concurrent E2496/COG* Outcomes in adolescents and young adults (AYA) with cetuximab investigating EGFR FISH in patients with advanced non-small hodgkin lymphoma (HL) treated on US cooperative group protocols: an cell lung cancer: SWOG S0819 . R Herbst, M Redman, E Kim, T Semrad, L adult intergroup (E2496) and Children’s Oncology Group (COG AHOD Bazhenova, G Masters, K Oettel, P Guaglianone, C Reynolds, A Karnad, S 0031) comparative analysis . TO Henderson, SK Parsons, K Wroblewski, L Arnold, M Varella-Garcia, J Moon, P Mack, C Blanke, F Hirsch, K Kelly, DR Chen, F Hong, S Smith, J McNeer, R Advani, R Gascoyne, LS Constine, S Gandara . Lancet Oncology, in press . Horning, NL Bartlett, B Shah, JM Connors, J Leonard, BS Kahl, K Kelly, CL Schwartz, H Li, JW Friedberg, DL Friedman, LI Gordon, AM Evens . Cancer, S0905 Phase I trial of cediranib in combination with cisplatin and in press . [*COG AHOD 0031] pemetrexed in chemonaive patients with unresectable malignant pleural mesothelioma (SWOG S0905) . AS Tsao, MD, J Moon, II Wistuba, Submitted Manuscripts MD, NJ Vogelzang, GP Kalemkerian, MW Redman, DR Gandara, K Kelly . S0016 Impact of histologic grading on survival in the SWOG S0016 Journal of Thoracic Oncology Aug;12(8):1299-1308, 2017 . https://www . follicular lymphoma cohort . L Rimsza, H Li, R Braziel, C Spier, D Persky, ncbi nlm. nih. gov/pubmed/28599887. J Dunlap, M LeBlanc, N Barlett, JP Leonard, SM Smith, OW Press, JW Friedberg . Haematologica, pending revision/resubmission .

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S0016 Continued excellent outcomes in previously untreated follicular Melanoma Committee lymphoma patients after treatment with CHOP plus Rituximab or Published/Accepted Manuscripts CHOP plus 131Iodine-Tositumomab - long term follow-up of Phase III randomized study SWOG-S0016 . M Shadman, H Li, L Rimsza, JP Leonard, E2607 A Phase II trial of dasatinib in patients with unresectable locally MS Kaminski, RM Braziel, CM Spier, AK Gopal, DG Maloney, B Cheson, S advanced or stage IV mucosal, acral and vulvovaginal melanoma: a trial Dakhil, M LeBlanc, SM Smith, RI Fisher, JW Friedberg, OW Press . Journal of the ECOG-ACRIN Cancer Research Group (E2607) . K Kalinsky, S Lee, of Clinical Oncology, resubmitted . K Rubin, DP Lawrence, AJ Lafrarte, DR Borger, KA Margolin, MM Leitao, Jr, AA Tarhini, HB Koon, AL Pecora, AJ Jaslowski, GI Cohen, TM Kuzel, CD S0410 Tandem autologous hematopoietic cell transplantation for patients Lao, JM Kirkwood . Journal of Clinical Oncology Jul 15;123(14):2688-2697, with primary progressive or recurrent hodgkin lymphoma: a SWOG and 2017 . https://www .ncbi .nlm .nih gov/pubmed/28334439. Blood & Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703) . EP Smith, H Li, JW Friedberg, LS Constine, LM E4697 Immune correlates of GM-CSF and melanoma peptide vaccination Rimsza, JR Cook, GG Laport, LL Popplewell, L A Holmberg, SM Smith, in a randomized trial for the adjuvant therapy of resected high-risk M LeBlanc, SJ Forman, RI Fisher, PJ Stiff . Biology of Blood and Marrow melanoma (E4697) . L Butterfield, F Zhao, S Lee, A Tarhini, K Margolin, R Transplantation, pending revision/resubmission . White, M Atkins, G Cohen, T Whiteside, J Kirkwood, D Lawson . Clinical Cancer Research Sep 1;23(17):5034-5043, 2017 . https://www .ncbi .nlm . S0801 Phase 2 study of RCHOP, radioimmunotherapy and maintenance nih gov/pubmed/28536308. rituximab in untreated follicular lymphoma: SWOG S0801 . PM Barr, H Li, WR Burack, M LeBlanc, SM Smith, AK Gopal, JD Floyd, DO Persky, OW Submitted Manuscripts Press, RI Fisher, JW Friedberg . Lancet Haematology, under review . No publication information for this cycle . S0806 A Phase I/II trial of vorinostat (SAHA) in combination with rituximab- chop in patients with newly diagnosed advanced stage diffuse large Other B-cell lymphoma (DLBCL): SWOG S0806 . DO Persky, H Li, LM Rimsza, PM Submitted Manuscripts Barr, LL Popplewell, CL Bane, A Von Gehr, M LeBlanc, RI Fisher, SM Smith, JW Friedberg . American Journal of Hematology, submitted . Multiple Studies Frequency and description of drug interaction screening within SWOG Clinical Trials . DL Hertz, R Siden, J Modlin, L Au, LL Gabel, C50604 Results of US intergroup trial of response-adapted chemotherapy S-F Wong . American Journal of Health-System Pharmacy, under review . or chemotherapy/radiation therapy based on interim FDG-PET for non- bulky stage I and II hodgkin lymphoma . DJ Straus, S-H Jung, B Pitcher, L Kostakoglu, JC Grecula, ED Hsi, H Schöder, LL Popplewell, JE Chang, CH Moskowitz, N Wagner-Johnson, JP Leonard, JW Friedberg, BS Kahl, BD Cheson, NL Bartlett . Journal of Clinical Oncology, submitted 9/5/17 .

CTSU 9177 Multicenter Phase II study of DA-EPOCH-R in MYC-rearranged aggressive B-cell lymphoma . K Dunleavy, MA Fanale, JS Abramson, A Noy, P Fabrizio Caimi , S Pittaluga, S Parekh, A Lacasce, JW Hayslip, D Jagadeesh , S Nagpal, MJ Lechowicz, R Gaur, JW Leach, A Lucas, C Melani, M Roschewski, SM Steinberg, ES Jaffe, B Kahl, JW Friedberg, RF Little, NL Bartlett, WH Wilson . Blood, submitted .

SWOG FACT SWOG Impact: 14 new drugs, more than 100 changes to standard of care, more than 3 million years of life saved

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