Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma-long-term results of phase III RTOG 85-31
- University of California, Los Angeles, School of Medicine, Los Angeles, CA (United States)
- Radiation Therapy Oncology Group, Philadelphia, PA (United States)
- Medical College of Wisconsin, Milwaukee, WI (United States)
- University of Pennsylvania, Philadelphia, PA (United States)
- Radiology Associates of Sacramento, Sacramento, CA (United States)
- Fox Chase Cancer Center, Philadelphia, PA (United States)
- Dartmouth Hitchcock Medical Center, Lebanon, NH (United States)
- Albert Einstein Medical Center, Philadelphia, PA (United States)
- Wayne State University, Detroit, MI (United States)
Purpose: Radiation Therapy Oncology Group protocol 85-31 was designed to evaluate the effectiveness of adjuvant androgen suppression, using goserelin, in unfavorable prognosis carcinoma of the prostate treated with definitive radiotherapy (RT). Methods and Materials: Eligible patients were those with palpable primary tumor extending beyond the prostate (clinical Stage T3) or those with regional lymphatic involvement. Patients who had undergone prostatectomy were eligible if penetration through the prostatic capsule to the margin of resection and/or seminal vesicle involvement was documented histologically. Stratification was based on histologic differentiation, nodal status, acid phosphatase status, and prior prostatectomy. The patients were randomized to either RT and adjuvant goserelin (Arm I) or RT alone followed by observation and application of goserelin at relapse (Arm II). In Arm I, the drug was to be started during the last week of RT and was to be continued indefinitely or until signs of progression. Results: Between 1987 and 1992, when the study was closed, 977 patients were entered: 488 to Arm I and 489 to Arm II. As of July 2003, the median follow-up for all patients was 7.6 years and for living patients was 11 years. At 10 years, the absolute survival rate was significantly greater for the adjuvant arm than for the control arm: 49% vs. 39%, respectively (p = 0.002). The 10-year local failure rate for the adjuvant arm was 23% vs. 38% for the control arm (p <0.0001). The corresponding 10-year rates for the incidence of distant metastases and disease-specific mortality was 24% vs. 39% (p <0.001) and 16% vs. 22% (p = 0.0052), respectively, both in favor of the adjuvant arm. Conclusion: In a population of patients with unfavorable prognosis carcinoma of the prostate, androgen suppression applied as an adjuvant after definitive RT was associated not only with a reduction in disease progression but in a statistically significant improvement in absolute survival. The improvement in survival appeared preferentially in patients with a Gleason score of 7-10.
- OSTI ID:
- 20696159
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 61, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2004.08.047; PII: S0360-3016(04)02468-X; Copyright (c) 2005 Elsevier Science B.V., Amsterdam, 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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