CHICAGO, IL USA (UroToday.com) - Presented by Charles J. Ryan, MD16 on behalf of Dana Rathkopf,1 Matthew R. Smith,2 Johann S. de Bono,3 Christopher J. Logothetis,4 Neal D. Shore,5 Paul de Souza,6 Karim Fizazi,7 Peter F.A. Mulders,8 Paul Mainwaring,9 John D. Hainsworth,10 Tomasz M. Beer,11 Scott North,12 Yves Fradet,13 Thomas Griffin,1 Youn C. Park,15 Thian Kheoh,14 Eric J. Small,16 Howard I. Scher,1 and Arturo Molina14 at the American Society of Clinical Oncology (ASCO) Annual Meeting - May 31 - June 4, 2013 - McCormick Place - Chicago, IL USA
Click HERE to view the poster from this session
1Memorial Sloan-Kettering Cancer Center, New York, NY; 2Massachusetts General Hospital Cancer Center, Boston, MA; 3Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK; 4MD Anderson Cancer Center, Houston, TX; 5Carolina Urologic Research Center, Myrtle Beach, SC; 6University of Western Sydney School of Medicine, Ingham Institute, Liverpool, Australia; 7Institut Gustave Roussy, University of Paris Sud, Villejuif, France; 8Radboud University Medical Centre, Nijmegen, The Netherlands; 9Haematology and Oncology Clinics of Australia, Brisbane, Australia; 10Sarah Cannon Research Institute, Nashville, TN; 11Oregon Health & Science University Knight Cancer Institute, Portland, OR; 12Cross Cancer Institute, Edmonton, Alberta, Canada; 13Laval University, Quebec, Canada; 14Janssen Research & Development, Los Angeles, CA; 15Janssen Research & Development, Raritan, NJ; 16Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA
Long-term safety and efficacy analysis of abiraterone acetate (AA) plus prednisone (P) in metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy (COU-AA-302)
Dana E. Rathkopf, Matthew R. Smith, Johann Sebastian De Bono, Christopher Logothetis, Neal Shore, Paul L. De Souza, Karim Fizazi, Peter Mulders, Paul N. Mainwaring, John D Hainsworth, Tomasz M. Beer, Scott A. North, Yves Fradet, Thomas W. Griffin, Youn Choi Park, Thian San Kheoh, Eric Jay Small, Howard I. Scher, Arturo Molina, Charles J. Ryan
Memorial Sloan-Kettering Cancer Center, New York, NY; Massachusetts General Hospital Cancer Center, Boston, MA; The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom; The University of Texas MD Anderson Cancer Center, Houston, TX; Carolina Urologic Research Center, Myrtle Beach, SC; University of Western Sydney School of Medicine, Ingham Institute, Liverpool, Australia; Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Radboud University Medical Centre, Nijmegen, Netherlands; Haematology and Oncology Clinics of Australia, Brisbane, Australia; Sarah Cannon Research Institute, Nashville, TN; Oregon Health & Science University Knight Cancer Institute, Portland, OR; Cross Cancer Institute, Edmonton, AB, Canada; Laval University, Québec, QC, Canada; Janssen Research & Development, LLC, Los Angeles, CA; Janssen Research & Development, LLC, Raritan, NJ; Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, CA
Background: AA, a CYP17 inhibitor, prolongs the lives of men with progressive pre- or post-chemotherapy treated mCRPC with a favorable safety profile (Rathkopf et al. ASCO-GU 2013. Abstr 5). This post hoc analysis examines the safety and tolerability of long-term treatment (≥ 24 mos) in study COU-AA-302.
Methods: 1,088 pts were randomized 1:1 to AA 1000 mg + P 5 mg po BID vs placebo + P. Co-primary endpoints were radiographic progression-free survival (rPFS) and OS. Median times with 95% CI of the end points were estimated using the Kaplan-Meier (KM) method. Post hoc analysis of adverse events (AEs) was performed at pre-specified interim analysis (IA3) (55% OS events).
Results: At a median follow-up = 27.1 mos (IA3): rPFS HR (95% CI) 5 0.53 (0.45, 0.62), p < 0.0001 and OS was improved over P (0.79 (0.66, 0.96), p 5 0.0151); the latter did not reach the pre-specified efficacy boundary (p = 0.0035). All secondary endpoints favored the AA arm (Rathkopf et al. ASCO-GU 2013. Abstr 5). There was no clinically relevant increase in the incidence rate of AEs with longer exposure using AA + P versus P alone; although pts on treatment for ≥ 24 mos may have had greater tolerability. The percentage of patients who came off study due to an AE was 8% (AA) versus 6% (P).
Conclusions: The updated IA3 of COU-AA-302 in pts without prior chemotherapy confirms the delay in progression and prolongation of life with a favorable safety profile including pts treated for ≥ 24 mos with AA + P or P. Clinical trial information: NCT00887198.
Charles J. Ryan, MD is an associate professor of medicine in the Division of Hematology / Oncology at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco (UCSF) where he is the leader of the Genitourinary Medical Oncology Program. He received his MD from the University of Wisconsin in Madison and completed his residency in internal medicine at the University of Wisconsin Hospital and Clinics, where he also served as chief resident. He completed a fellowship in medical oncology in the Department of Medicine at Memorial Sloan-Kettering Cancer Center and the Joan and Sanford I. Weill Medical College of Cornell University in New York.
His clinical and research work centers on the design and conduct of clinical trials of novel therapies for advanced prostate cancer, specifically secondary hormonal therapies targeting adrenal androgen signaling, insulin growth factor inhibitors, androgen receptor targeted therapy and chemotherapy. In addition to clinical trials, Dr. Ryan collaborates with many laboratories researching the role of the androgen receptor and other signaling mechanisms in prostate cancer patients.
Dr. Ryan is a member of several honor societies and is the recipient of a Leadership and Service Award and the John Kimberly Curtis Award from the University of Wisconsin Medical School. He received the American College of Physicians/American Society of Internal Medicine Evergreen Award in 2000 and the American Society of Clinical Oncology Merit Award and Cancer and Leukemia Group B: Young Investigator Award, both in 2003. He was awarded the Donald Coffey Career Development Award from the Prostate Cancer Foundation in 2006 and a California Coalition to Cure Prostate Cancer Award in 2007.
The ASCO Annual Meeting brings together more than 25,000 oncology professionals from a broad range of specialties, making it an excellent venue for exploring the theme of the Meeting — "Building Bridges to Conquer Cancer."