Weekly docetaxel and epirubicin in treatment of advanced hormone-refractory prostate cancer.

ABSTRACT

OBJECTIVES: To evaluate the efficacy and safety of a new regimen that combines weekly docetaxel and weekly epirubicin for the treatment of advanced hormone-refractory prostate cancer. METHODS: Docetaxel 30 mg/m2 and epirubicin 30 mg/m2 were intravenously administered on a weekly basis, for a maximum of 24 cycles. The therapy was discontinued after the first 12 cycles in the patients who responded or had stable disease and was resumed as soon as any signs of progression were noted. RESULTS: Of the 38 evaluable patients, 26 achieved a confirmed greater than 50% decrease in prostate-specific antigen level (68.4%, 95% confidence interval [CI] 51.2% to 82.0%). The median response duration was 8.8 months (95% CI 6.2 to 11.8), and the median time to progression was 7.4 months (95% CI 5.6 to 9.6). Pain was rapidly reduced in 24 (72.7%, 95% CI 54.2 to 86.7) of the 33 patients who were symptomatic at baseline. Of the 38 patients, 21 resumed therapy after the planned interruption; of these, 3 had a prostate-specific antigen response (14.2%) and 12 had stable disease (57.1%). The regimen was well tolerated. Grade 3 neutropenia occurred in 15.7% of the patients, grade 3 anemia in 13.1%, and grade 3 thrombocytopenia in 7.8%. CONCLUSIONS: The results of this study have suggested the feasibility and tolerability of the combination of weekly docetaxel and weekly epirubicin, which led to a rapid and long-lasting decrease in prostate-specific antigen levels and a palliative response in patients with advanced hormone-refractory prostate cancer.