International Journal of Radiation Oncology*Biology*Physics
Clinical investigationsProstateAndrogen suppression adjuvant to definitive radiotherapy in prostate carcinoma—long-term results of phase III RTOG 85–31
Introduction
In the early 1980s, the Radiation Therapy Oncology Group (RTOG) began a series of studies looking at the potential usefulness of hormonal management in conjunction with definitive radiotherapy (RT) in carcinoma of the prostate. After completion of several Phase II trials, the group initiated two Phase III trials in the mid-1980s. These studies have reached maturity. The current report is a long-term update of the first large-scale Phase III trial of androgen suppression applied as an adjuvant after definitive RT.
Section snippets
Methods and materials
RTOG 85–31 was a Phase III trial designed to evaluate the effectiveness of elective (adjuvant) androgen suppression using goserelin acetate (Zoladex, Zeneca Pharmaceuticals, Wilmington, DE) on disease progression and survival in a population of patients with carcinoma of the prostate who were considered at high risk of relapse and tumor-related death.
Results
Between February 1987 and April 1992, when the study was closed, a total of 977 patients were accessioned. Of these, 488 were entered in the adjuvant arm (Arm I) and 489 in the observation arm (Arm II); 32 patients were retrospectively classified as ineligible and were excluded from the subsequent analysis, leaving 477 analyzable cases in Arm I and 468 in Arm II. The pretreatment characteristics are listed in Table 1. Figure 1 shows the absolute survival for the entire study population. At 10
Discussion
Hormonal management (androgen suppression) is a well-established modality in the treatment of patients with prostate carcinoma. Although traditionally used primarily as a palliative tool in patients with advanced disease, androgen suppression has been increasingly tested and used in a combination with surgery and RT (7, 8, 9, 10, 11, 12, 13, 14).
When considering the use of androgen suppression in conjunction with definitive RT, it is important to recognize several potential modes of interaction
Conclusion
The results of RTOG 85–31 substantiate a powerful beneficial effect of adjuvant androgen suppression. Although an improvement in all endpoints was substantiated for the entire study population, the adjuvant effect appeared preferentially in patients with a high Gleason score. This observation poses a significant practical question in the treatment of patients with a Gleason score of 2–6. Long-term adjuvant suppression with its cost and treatment-related morbidity (12, 13, 14, 15, 16, 17) may
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Supported by Public Health Services Grants CA-21661 and CA-32115 from the National Cancer Institute, National Institutes of Health, Bethesda, MD.