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Title: 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

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 CTmore » 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.« less
Authors:
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6] ;  [7] ;  [8] ;  [1] ;  [9] ;  [10] ;  [11] ;  [12] ;  [13] ;  [14] ;  [15] ;  [16] ;  [17] ;  [18] ;  [19] more »; « less
  1. Radiation Oncology, Sutter Cancer Centers, Roseville, California (United States)
  2. NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States)
  3. Tulane University Medical Center, New Orleans, Louisiana (United States)
  4. Johns Hopkins School of Medicine, Baltimore, Maryland (United States)
  5. Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States)
  6. Indiana University, Bloomington, Indiana (United States)
  7. McGill University, Montreal, Quebec (Canada)
  8. Community Clinical Oncology Program, Southeast Cancer Control Consortium, Inc, Winston-Salem, North Carolina (United States)
  9. (United States)
  10. University of Alabama at Birmingham Medical Center, Birmingham, Alabama (United States)
  11. Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (United States)
  12. Albert Einstein Medical Center, Bronx, New York (United States)
  13. University of Michigan Medical Center, Ann Arbor, Michigan (United States)
  14. Christiana Care Health Services, Inc, Wilmington, Delaware (United States)
  15. State University of New York Health Science Center–Brooklyn, Brooklyn, New York (United States)
  16. Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States)
  17. Washington University, St. Louis, Missouri (United States)
  18. Akron City Hospital, Akron, Ohio (United States)
  19. Wayne State University, Detroit, Michigan (United States)
Publication Date:
OSTI Identifier:
22458776
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 93; Journal 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)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANDROGENS; ANTIGENS; CHEMOTHERAPY; CLINICAL TRIALS; COMPUTERIZED TOMOGRAPHY; DATA; FAILURES; HYPOTHESIS; INHIBITION; LIBERINS; LUTEINIZING HORMONE; METASTASES; NEOPLASMS; PATIENTS; PROSTATE; RADIOTHERAPY; TOXICITY