Chemo-endocrine therapy for prostate cancer with bone metastasis. Nagasaki Prostate Cancer Research Group.

We analyzed the clinical effects of initial chemoendocrine therapy on 31 prostate cancer patients with bone metastasis. These patients had been newly diagnosed between 1983 and 1991 and had received no previous therapy. As endocrine therapy, the patients received 1 mg ethynylestradiol daily with or without orchiectomy. In addition, they received three courses of chemotherapy consisting of 20 mg/m2 cisplatin given on days 1, 3, and 5 and 20 mg/m2 Adriamycin or 40 mg/m2 epirubicin given on day 5. Subsequently, for maintenance therapy, the patients received 1 mg ethynylestradiol and 150 mg 5-fluorouracil [or 300 mg tegafur plus uracil (UFT)] daily. Patients given our regimen of chemoendocrine therapy had a significantly better prognosis than did the controls treated with endocrine therapy alone (P = 0.05), although treatment was not randomized. The cause-specific survival rates at 5 years for the chemoendocrine-therapy patients and the control group were 65.4% and 37.4%, respectively. A multivariate analysis of possible prognostic factors, i.e., age, histological grade, prostatic acid phosphatase, tumor-related pain, the extent of disease (EOD) on bone scan, and the type of initial treatment, confirmed that the initial treatment (P = 0.03) and the EOD grade (P = 0.05) had a significant effect on survival. On the basis of these results, it is necessary to carry out a randomized trial to compare our chemoendocrine regimen with endocrine therapy alone in untreated patients with advanced prostate cancer.

RCT Entities:   Population Interventions Outcomes