Phase II trial of doxorubicin in bidimensionally measurable prostatic adenocarcinoma.

Intravenous doxorubicin (30 to 60 mg. per m.2 every 3 weeks) was administered to 52 patients with metastatic adenocarcinoma of the prostate, including 41 with bidimensionally measurable soft tissue lesions. Prior therapy in the measurable disease group included hormonal manipulation in 39 cases, irradiation in 39 and cytotoxic drugs in 19. In 39 of 41 adequately treated patients with soft tissue lesions only 2 (5 per cent, 95 per cent confidence limits 0 to 12 per cent) achieved a partial remission for 12 and 6 months, respectively, 3 had a minor response for 5, 4 and 3 months, respectively, and 1 had stabilization of disease for 4 months. Survival in this group was 16 months versus 5 months for patients with a mixed response and progression of disease. Of 11 patients with evaluable parameters only 1 had stabilization and 5 showed subjective improvement. Recognizing the patient selection bias and treatment schedule in this study, we believe that doxorubicin has marginal activity in soft tissue lesions in patients with advanced prostatic cancer.