Colleen A F Lawton1, Xiaolei Lin2, Gerald E Hanks3, Herbert Lepor4, David J Grignon5, Harmar D Brereton6, Meena Bedi7, Seth A Rosenthal8, Kenneth L Zeitzer9, Varagur M Venkatesan10, Eric M Horwitz3, Thomas M Pisansky11, Harold Kim12, Matthew B Parliament13, Rachel Rabinovitch14, Mack Roach15, Young Kwok16, James J Dignam17, Howard M Sandler18. 1. Medical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: clawton@mcw.edu. 2. University of Chicago, Chicago, Illinois. 3. Fox Chase Cancer Center, Philadelphia, Pennsylvania. 4. New York University, New York, New York. 5. Indiana University, Indianapolis, Indiana. 6. Northeast Radiation Oncology Center, Dunmore, Pennsylvania. 7. Medical College of Wisconsin, Milwaukee, Wisconsin. 8. Sutter General Hospital, Sacramento, California. 9. Albert Einstein Medical Center, Philadelphia, Pennsylvania. 10. London Regional Cancer Program, London, Ontario, Canada. 11. Mayo Clinic, Rochester, Minnesota. 12. Wayne State University-Karmanos Cancer Institute, Detroit, Michigan. 13. Cross Cancer Institute, Edmonton, Alberta, Canada. 14. University of Colorado Denver, Denver, Colorado. 15. University of California, San Francisco, California. 16. University of Maryland Medical System, Baltimore, Maryland. 17. University of Chicago, Chicago, Illinois; NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania. 18. Cedars-Sinai Medical Center, Los Angeles, California.
Abstract
PURPOSE: Trial RTOG 9202 was a phase 3 randomized trial designed to determine the optimal duration of androgen deprivation therapy (ADT) when combined with definitive radiation therapy (RT) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate. Long-term follow-up results of this study now available are relevant to the management of this disease. METHODS AND MATERIALS: Men (N=1554) with adenocarcinoma of the prostate (cT2c-T4, N0-Nx) with a prostate-specific antigen (PSA) <150 ng/mL and no evidence of distant metastasis were randomized (June 1992 to April 1995) to short-term ADT (STAD: 4 months of flutamide 250 mg 3 times per day and goserelin 3.6 mg per month) and definitive RT versus long-term ADT (LTAD: STAD with definitive RT plus an additional 24 months of monthly goserelin). RESULTS: Among 1520 protocol-eligible and evaluable patients, the median follow-up time for this analysis was 19.6 years. In analysis adjusted for prognostic covariates, LTAD improved disease-free survival (29% relative reduction in failure rate, P<.0001), local progression (46% relative reduction, P=.02), distant metastases (36% relative reduction, P<.0001), disease-specific survival (30% relative reduction, P=.003), and overall survival (12% relative reduction, P=.03). Other-cause mortality (non-prostate cancer) did not differ (5% relative reduction, P=.48). CONCLUSIONS:LTAD and RT is superior to STAD and RT for the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate and should be considered the standard of care. Published by Elsevier Inc.
RCT Entities:
PURPOSE: Trial RTOG 9202 was a phase 3 randomized trial designed to determine the optimal duration of androgen deprivation therapy (ADT) when combined with definitive radiation therapy (RT) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate. Long-term follow-up results of this study now available are relevant to the management of this disease. METHODS AND MATERIALS: Men (N=1554) with adenocarcinoma of the prostate (cT2c-T4, N0-Nx) with a prostate-specific antigen (PSA) <150 ng/mL and no evidence of distant metastasis were randomized (June 1992 to April 1995) to short-term ADT (STAD: 4 months of flutamide 250 mg 3 times per day and goserelin 3.6 mg per month) and definitive RT versus long-term ADT (LTAD: STAD with definitive RT plus an additional 24 months of monthly goserelin). RESULTS: Among 1520 protocol-eligible and evaluable patients, the median follow-up time for this analysis was 19.6 years. In analysis adjusted for prognostic covariates, LTAD improved disease-free survival (29% relative reduction in failure rate, P<.0001), local progression (46% relative reduction, P=.02), distant metastases (36% relative reduction, P<.0001), disease-specific survival (30% relative reduction, P=.003), and overall survival (12% relative reduction, P=.03). Other-cause mortality (non-prostate cancer) did not differ (5% relative reduction, P=.48). CONCLUSIONS: LTAD and RT is superior to STAD and RT for the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate and should be considered the standard of care. Published by Elsevier Inc.
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