Phase II study of orchiectomy combined with epirubicin as first-line treatment in advanced prostate carcinoma

Nineteen patients with metastatic prostate cancer were treated with orchiectomy plus six cycles of epirubicin in a dose of 90 mg/m2, intravenously, every 28 days. Median age was 63 years (range, 52-74 years). Sixteen patients had only bone metastases and 3 had soft tissue lesions plus bone metastases. Fifty-six percent had poorly differentiated adenocarcinoma. Response in patients with bone metastases was assessed by National Prostatic Cancer Project criteria. Of 19 patients, 9 (47%) achieved a complete and 7 (37%) a partial remission. The median duration of response was 20 months and the median survival time of all patients was 24 months (range, 3-100+ months). Toxicity was moderate and consisted of alopecia and mild nausea/vomiting. There was no significant hematological toxicity. It is concluded that the combined modality treatment with orchiectomy plus a cytotoxic drug, i.e., epirubicin, is feasible and does not appear antagonistic. Randomized studies should be initiated to prove or disprove a potential survival benefit of the combined modality as a first-line treatment.