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Clinical Roundtable Monograph Clinical Advances in Hematology & Oncology November 2017 Recent Advances in the Treatment of Pancreatic Adenocarcinoma Faculty Fadi Braiteh, MD Director of the Translational Oncology Program Phase I and GI Malignancies Program Comprehensive Cancer Centers of Nevada Clinical Associate Professor University of Nevada School of Medicine Las Vegas, Nevada Ramesh K. Ramanathan, MD Professor of Medicine Mayo Medical School Mayo Clinic Cancer Center A CME Activity Phoenix, Arizona Approved for 1.00 AMA PRA Tanios Bekaii-Saab, MD Category 1 Credit(s) TM Professor, Mayo Clinic College of Medicine and Science Program Co-Leader, GI Cancer Mayo Clinic Cancer Center Release Date: November 1, 2017 Senior Associate Consultant, Mayo Clinic Arizona Expiration Date: November 30, 2018 Phoenix, Arizona Estimated time to complete activity: 1.00 hours Project ID: 12748 Abstract: Although pancreatic cancer is rare, it is the fourth-leading cause of cancer-related mortality. Pancreatic adenocarcinoma is the most common type of pancreatic cancer, accounting for approximately 95% of cases. At diagnosis, it is estimated that less than 10% of patients have localized disease, 29% have regional disease, and 52% have distant metastases and might be eligible for palliative treatment only. Optimal management of pancreatic cancer requires early referral to a medical oncologist. Therapeutic goals should address both symptom improvement and survival. In the metastatic setting, advances in systemic therapy are improving outcome. For years, the standard therapy was single-agent gemcitabine, and this approach is still used for patients who have a poor performance status, who are elderly, or who have comorbidities. More recent strategies include oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus albumin-bound (nab)-paclitaxel. In 2015, the US Food and Drug Administration approved the use of nanoliposomal irinotecan in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Multiple novel strategies are being evaluated for patients with pancreatic cancer. A multidisciplinary team that includes an interventional gastroenterologist is appropriate for all patients with pancreatic cancer, regardless of disease stage. Proactive management of potential complications is essential for maintaining adherence to treatment and maximizing clinical outcomes. Supported through an educational grant Jointly provided by Postgraduate Institute for from Ipsen Biopharmaceuticals, Inc. Medicine and Millennium Medical Publishing Target Audience nentech, Boehringer Ingelheim, AbbVie, AstraZeneca, Celgene, Pfizer, Clovis, This activity has been designed to meet the educational needs of oncologists Lexicon, Taiho. and nurses involved in the management of patients with pancreatic cancer. Ramesh K. Ramanathan, MD—Consultant: Pharmacyclics. Research support: AbbVie, Merck, Celgene, Berg, Boston Medical, and Ipsen. Statement of Need/Program Overview Tanios Bekaii-Saab, MD—No real or apparent conflicts of interest to report. Pancreatic adenocarcinoma is the most common type of pancreatic cancer, ac- counting for approximately 95% of cases. For years, the standard therapy was The planners and managers reported the following financial relationships or rela- single-agent gemcitabine, and this approach is still used for patients who have tionships to products or devices they or their spouse/life partner have with com- a poor performance status, who are elderly, or who have comorbidities. For mercial interests related to the content of this CME activity: patients eligible for more aggressive therapy, options include oxaliplatin, iri- notecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus The following PIM planners and managers, Trace Hutchison, PharmD; albumin-bound (nab)-paclitaxel. A newer therapy that has shown a significant Samantha Mattiucci, PharmD, CHCP; Judi Smelker-Mitchek, RN, BSN; benefit in overall survival is nanoliposomal irinotecan, which is approved by and Jan Schultz, RN, MSN, CHCP hereby state that they or their spouse/life the US Food and Drug Administration (FDA) for use in combination with partner do not have any financial relationships or relationships to products or fluorouracil and leucovorin for the treatment of patients with metastatic ad- devices with any commercial interest related to the content of this activity of enocarcinoma of the pancreas after disease progression following gemcitabine- any amount during the past 12 months. Jacquelyn Matos: No real or appar- based therapy. With these newer treatment regimens, a small percentage of pa- ent conflicts of interest to report. Mindy Tanzola, PhD: No real or apparent tients are surviving for multiple years after a diagnosis of metastatic pancreatic conflicts of interest to report. cancer. This monograph describes the latest clinical data and provides insight into the best use of available therapies, including sequencing and management Method of Participation of adverse events. There are no fees for participating in and receiving CME credit for this activity. During the period November 1, 2017 through November 30, 2018, participants Educational Objectives must 1) read the learning objectives and faculty disclosures; 2) study the educa- After completing this activity, the participant should be better able to: tional activity; 3) complete the post-test by recording the best answer to each question in the answer key on the evaluation form; 4) complete the evaluation • Explain how a patient’s disease stage, age, and comorbidities influence selection form; and 5) mail or fax the evaluation form with answer key to Postgradu- of treatment for pancreatic adenocarcinoma ate Institute for Medicine. You may also complete the post-test online at www. • Discuss when to initiate palliative care cmeuniversity.com. On the navigation menu, click on “Find Post-test/Evaluation • Describe data from the latest clinical trials of therapies in pancreatic adeno- by Course” and search by course ID 12748. Upon registering and successfully carcinomas completing the post-test with a score of 75% or better and submitting the activ- • Devise management strategies based on guidelines from the National Com- ity evaluation, your certificate will be made available immediately. Processing prehensive Cancer Network and the European Society for Medical Oncology credit requests online will reduce the amount of paper used by nearly 100,000 sheets per year. Accreditation Statement This activity has been planned and implemented in accordance with the ac- A statement of credit will be issued only upon receipt of a completed activity creditation requirements and policies of the Accreditation Council for evaluation form and a completed post-test with a score of 75% or better. Your Continuing Medical Education (ACCME) through the joint provider- statement will be emailed to you within three weeks. ship of Postgraduate Institute for Medicine and Millennium Medical Pub- lishing, Inc. The Postgraduate Institute for Medicine is accredited by the Media ACCME to provide continuing medical education for physicians. Monograph Credit Designation Disclosure of Unlabeled Use The Postgraduate Institute for Medicine designates this enduring material This educational activity may contain discussion of published and/or inves- for a maximum of 1.00 AMA PRA Category 1 Credit(s)TM. Physicians should tigational uses of agents that are not indicated by the FDA. The planners of claim only the credit commensurate with the extent of their participation this activity do not recommend the use of any agent outside of the labeled in the activity. indications. PIM, Millennium Medical Publishing, Inc., and Ipsen Biophar- maceuticals, Inc. do not recommend the use of any agent outside of the labeled Disclosure of Conflicts of Interest indications. Postgraduate Institute for Medicine (PIM) requires instructors, planners, man- The opinions expressed in the educational activity are those of the faculty agers, and other individuals who are in a position to control the content of this and do not necessarily represent the views of the planners. Please refer to the activity to disclose any real or apparent conflict of interest (COI) they may official prescribing information for each product for discussion of approved have as related to the content of this activity. All identified COI are thoroughly indications, contraindications, and warnings. vetted and resolved according to PIM policy. PIM is committed to provid- ing its learners with high-quality CME activities and related materials that Disclaimer promote improvements or quality in healthcare and not a specific proprietary Participants have an implied responsibility to use the newly acquired informa- business interest of a commercial interest. tion to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for pa- The faculty reported the following financial relationships or relationships to tient management. Any procedures, medications, or other courses of diagnosis or products or devices they or their spouse/life partner have with commercial treatment discussed or suggested in this activity should not be used by clinicians interests related to the content of this CME activity: without evaluation of their patient’s conditions and possible contraindications