High dose epirubicin is effective in measurable metastatic prostate cancer: a phase II study of the EORTC Genitourinary Group.

39 hormone-resistant prostate cancer patients with bidimensionally measurable metastatic lesions were given epirubicin 100 mg/m2 intravenously every 3 weeks. One patient was ineligible and excluded from analyses. According to WHO criteria, 9 patients (24%) had a partial response, 16 patients (42%) had stable disease (including 3 patients (8%) with a partial response not confirmed 1 month later), 11 patients (29%) had progressive disease, and in 2 patients (5%) response was not evaluated. Toxicity was as expected. Fifty-five per cent of patients had WHO grade 3/4 toxicity for white blood cells, and 3% of patients grade 3 toxicity for platelets. Other toxicities included nausea and vomiting, mucositis and alopecia. 2 patients with pre-existing cardiac disease developed cardiotoxicity (1 grade 2, 1 grade 3). An attempt was made to correlate response with prostate specific antigen (PSA) measurements. A positive trend was seen, but 2 non-responding patients showed a > 50% decrease in value.