A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902
- NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States)
- Tulane University Medical Center, New Orleans, Louisiana (United States)
- Johns Hopkins School of Medicine, Baltimore, Maryland (United States)
- Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States)
- Indiana University, Bloomington, Indiana (United States)
- McGill University, Montreal, Quebec (Canada)
- Community Clinical Oncology Program, Southeast Cancer Control Consortium, Inc, Winston-Salem, North Carolina (United States)
- Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States)
- University of Alabama at Birmingham Medical Center, Birmingham, Alabama (United States)
- Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States)
- Albert Einstein Medical Center, Bronx, New York (United States)
- University of Michigan Medical Center, Ann Arbor, Michigan (United States)
- Christiana Care Health Services, Inc, Wilmington, Delaware (United States)
- State University of New York Health Science Center–Brooklyn, Brooklyn, New York (United States)
- Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States)
- Washington University, St. Louis, Missouri (United States)
- Akron City Hospital, Akron, Ohio (United States)
- Wayne State University, Detroit, Michigan (United States)
Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS). Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥7 or clinical stage ≥T2 and GS ≥8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05. Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61). Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for the feasibility of clinical trial accrual and tolerability using CT for PCa.
- OSTI ID:
- 22458776
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 93, Issue 2; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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