The Gynecologic Oncology Group The Gynecologic Oncology Group: 43 Years of Success Philip J. DiSaia, MD ‐ Group Chair The Gynecologic Oncology Group The Gynecologic Oncology Group: 43 Years of Success Philip J. DiSaia, MD ‐ Group Chair Acknowledgements A special word of gratitude to Mr. Kevin Schnieder for his editorial efforts in the production of this monograph. Dedications This effort is dedicated to current GOG Group Chair and President, Dr. Philip J. DiSaia. Copyright © 2013 by the Gynecologic Oncology Group Gynecologic Oncology Group Mission Statement The Gynecologic Oncology Group is a non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The Group is committed to maintaining the highest standards in clinical trials development, execution, and distribution of results. Continuous evaluation of our processes is utlized in order to constantly improve the quality of patient care. Preface | Philip J. DiSaia, MD Chair Since 1970, the Gynecologic Oncology Group (GOG) has moved the members of the Group themselves and the support provided progressively into the lead position among clinical trial groups by both the NCI and our industry partners. studying gynecologic cancer. The results of multiple GOG study protocols have formed the basis of the standard of care for many We look forward to many more years of productivity and success- malignant gynecologic neoplasms. Additionally, the GOG has con- ful research into gynecologic malignant neoplasia as we affiliate tributed greatly to improvements in staging procedures, quality of with NSABP and RTOG to form the new NRG Oncology. life analyses, and more recently, prevention knowledge. This monograph summarizes the highlights of the Group’s accom- plishments. None of these successes could have been achieved without our multi-disciplinary investigators and their institutions Philip J. DiSaia, MD, Chairman who have carried the burden of excellence in research despite less Gynecologic Oncology Group than recommended funding. The real heroes of our successes are July 2013 Contributing Authors | Philip J. DiSaia, MD Michael J. Birrer, MD, PhD The Dorothy J. Marsh Chair in Reproductive Biology Director of Medical Gynecologic Oncology Director, Division of Gynecologic Oncology Director, Gynecologic Oncology Research Program Professor, Department of Obstetrics and Gynecology Massachusetts General Hospital Cancer Center University of California, Irvine Professor of Medicine, Harvard Medical School Irvine, CA Boston, MA GOG Group Chair GOG Experimental Medicine Committee Chair Larry J. Copeland, MD John A. Blessing, PhD Professor and Chair Clinical Professor, Department of Biostatistics William Greenville Pace III and State University of New York at Buffalo Joann Norris Collins - Pace Chair, Buffalo, NY Department of Obstetrics/Gynecology GOG Executive Director, Statistical and Data Center The Ohio State University Hillard, OH Michael A. Bookman, MD GOG Group Co-Chair Division Chief, Hematology/Oncology Director, University of Arizona Cancer Center Robert C. Park, MD Clinical Research Shared Service GOG Administrative Office Tucson, AZ Philadelphia, PA GOG Ovarian Committee Chair GOG Board of Directors GOG Past Group Chair Mark F. Brady, PhD GOG Statistical and Data Center Roswell Park Cancer Center Carol Aghajanian, MD Buffalo NY Chief, Medical Oncology Service GOG Director of Statistics, Statistical and Data Center Memorial Sloan-Kettering Cancer Center Department of Medical Oncology Alan L. Covens, MD New York, NY Head, Gynecologic Oncology GOG Developmental Therapeutics Committee Chair Odette Cancer Centre-Sunnybrook Health Sciences Centre Toronto-Sunnybrook Regional Cancer Centre David S. Alberts, MD Toronto, ON, Canada Regents Professor of Medicine, Pharmacology, Nutritional GOG Rare Tumor Committee Co-Chair Sciences and Public Health Director, Arizona Cancer Center William T. Creasman, MD University of Arizona Health and Sciences Center J. Marion Sim Professor, Department of Obstetrics/Gynecology Tucson, AZ Medical University of South Carolina GOG Cancer Prevention and Control Committee Chair Charleston, SC GOG Human Research Committee Chair William T. Beck, MD Professor of Pharmacology and Molecular Genetics Paul A. DiSilvestro, MD Head, Department of Biopharmaceutical Science Director of Women’s Oncology Associate Dean for Research and Graduate Education Women & Infants Hospital College of Pharmacy Providence, RI University of Illinois at Chicago GOG Ovarian Cancer Committee Co-Chair Department of Biopharmaceutical Sciences Chicago, IL Gini F. Fleming, MD GOG Experimental Medicine Committee Co-Chair Professor of Medicine University of Chicago Chicago, IL GOG Treatment of Elderly Patients Working Group Chair The Gynecologic Oncology Group: 43 Years of Excellence Contributing Authors | iii Paula M. Fracasso, MD, PhD Susan Nolte, CRNP, PhD Professor of Medicine, Hematology and Oncology Nurse Practitioner Deputy Director of the Cancer Center and the Section Chief of Director of Clinical Research Medical Oncology Hanjani Institute for Gynecologic Oncology University of Virginia Cancer Center Abington Memorial Hospital Charlottesville, VA Abington, PA GOG Phase I Subcommittee Chair GOG Nursing Committee Chair David M. Gershenson, MD Marcus E. Randall, MD Professor, Obstetrics, Gynecology and Reproductive Sciences Markey Cancer Foundation Chair in Radiation Medicine M.D. Anderson Cancer Center Professor and Chairman of the Department Department of GYN/ONC of Radiation Medicine The University of Texas Chandler Medical Center Houston, TX University of Kentucky College of Medicine GOG Rare Tumor Committee Chair Lexington, KY GOG Uterine Corpus Committee Co-Chair William J. Hoskins, MD Executive Director of Surgical Activities J. Tate Thigpen, MD Department of Surgery Professor of Medicine Memorial Sloan-Kettering Cancer Center Director, Division of Oncology New York, NY University of Mississippi Medical Center Department of Medical Oncology Wui-Jin Koh, MD Jackson, MS Associate Professor, Department of Radiation Oncology GOG Partners Committee Chair University Cancer Center University of Washington Medical Center Joan L. Walker, MD Seattle, WA Professor and Chair GOG Cervix Committee Chair Department of Obstetrics and Gynecology University of Oklahoma Health and Science Center Robert S. Mannel, MD Oklahoma City, OK Rainbolt Family Chair in Cancer GOG Cancer Prevention and Control Committee Co-Chair Director, Peggy and Charles Stephenson Cancer Center Professor and Chair, Department of Obstetrics and Gynecology Lari B. Wenzel, MD University of Oklahoma Health and Sciences Center Professor and Associate Dean Oklahoma City, OK for Faculty Development, Medicine GOG Protocol Development Committee Chair School of Medicine University of California, Irvine David S. Miller, MD Irvine, CA Professor and Chief of the Division of Gynecologic Oncology GOG Health Outcomes Research Committee Chair Department of Obstetrics and Gynecology The University of Texas Southwestern Medical Center Dallas, TX Bibliography GOG Uterine Corpus Committee Chair Sally Bialy, MA Bradley J. Monk, MD GOG Statistical and Data Center Professor, Obstetrics and Gynecology Roswell Park Cancer Center Director of the Division of Gynecologic Oncology Buffalo NY St. Joseph’s Hospital and Medical Center GOG Director of Administration, Statistical and Data Center Creighton University School of Medicine Phoenix, AZ GOG Cervix Cancer Committee Chair The Gynecologic Oncology Group: 43 Years of Excellence Table of Contents | Preface . .i Chapter 4: Establishing a New Paradigm in Uterine (DiSaia) Corpus Malignancies (Miller, Randall, Flemiing, Bookman) . .30 Contributing Authors . .ii Introduction . .30 Surgical Staging . .30 Chapter 1: History of the Gynecologic Oncology Group Laparoscopy . .31 (DiSaia, Lewis, Park) . .1 Single Modality Adjuvant Therapy: Introduction . .1 Radiation therapy or Chemotherapy . .31 Initial Organizational Efforts . .1 Combined Modality Adjuvant Therapy with A Proud History and a Productive Future . .5 Radiation Therapy and Chemotherapy . .32 Pelvic Only Recurrent Disease . .32 Chapter 2: The Gynecologic Oncology Group Scientific Hormonal Therapy . .32 Process: A Unique Approach to Cooperative Clinical Trials Chemotherapy . .33 (Thigpen, Blessing) . .7 Chemotherapy Plus Hormonal Therapy . .34 General Characteristics of Cooperative Groups . .7 Biologic Therapy . .35 Evolution of the GOG Process: 1976-2003 . .8 Tumor Biology . .35 Empowerment of Members . .8 Quality of Life . .35 Multidisciplinary Collaboration . .9 Imaging . .36 Timely Publication . .9 Summary . .36 Intergroup Collaboration . .9 Uterine Sarcomas . .36 Evolution of the GOG Process: 2003-2013 . .9 Surgery . .36 Reorganization of the Protocol Committee . .9 Radiotherapy . .36 Establishment of a CTEP-Independent Initiative . .10 Chemotherapy . .37 Unique Features of the GOG Process . .10 Gestational Trophoblastic Neoplasia . .38 The GOG Process in Perspective . .11 Conclusion . .38 Chapter 3: Gynecologic Oncology Group Trials Chapter 5: Developing New Approaches in the Treatment in Ovarian Cancer of Carcinoma of the Cervix (DiSilvestro, Hoskins, Copeland, Mannel) . .13 (Monk, Koh) . .43 Introduction . .13 Studies in Early Stage Cervical Cancer: Early Stage Ovarian Cancer . .13 Preinvasive Disease . .43 Optimally Debulked Advanced Epithelial Ovarian Cancer . .14 Stage IA/IB1 Disease . .43 Optimally Debulked, Advanced Stage, Intraperitoneal