Phase II study of epirubicin, mitomycin c, and 5-fluorouracil in hormone-refractory prostatic carcinoma

Management of metastatic prostatic carcinoma when it becomes refractory to hormonal therapy is controversial, and no standard treatment exists. Nevert heless, chemotherapy for hormone-refractory prostatic carcinoma (HRPC) has shown some advantages compared with the best supportive care. In a prospect ive phase II study, we evaluated the combination of epirubicin CE), mitomyc in C (MMC), and 5-fluorouracil (5-FU) in patients with HRPC. Twenty-eight p atients with HRPC were treated with a combination of E (30 mg/m(2)), 5-FU ( 750 mg/m(2)), and MMC (5 mg/m(2)) day 1 and 2, every 4 weeks. Treatment was continued until evidence of disease progression or excessive toxicity. Pat ients were monitored with serial measurements of prostate-specific antigen (PSA). Forty-seven per cent of the patients exhibited a reduction of serum PSA concentration and an objective response; 38% exhibited disease stabilit y and 15% had disease progression. Toxicity was substantial. The median tim e to progression was 7.3 months (range, 1.7-16.8 months) and median surviva l was 14.5 months (range, 1.6-38.4 months). Performance status improved in 80% of patients, and bone pain was relieved in 70%. Thus the combination of E, MMC, and 5-FU shows activity in the treatment of HRPC, giving substanti al palliation of symptoms. In one patient, PSA values remained low even whe n the tumor had progressed.