Anthracyclines and cisplatin have been shown separately to have modest acti
vity in prostate cancer. The synergism between anthracyclines and cisplatin
, with the lack of overlapping toxicities, led to the conduct of this phase
II trial of the combination of epirubicin and cisplatin in hormone-refract
ory metastatic prostate cancer. Twenty-one evaluable patients with hormone-
refractory metastatic prostate cancer received epirubicin 100 mg/m(2) follo
wed by cisplatin 80 mg/m(2) with prehydration and mannitol diuresis. Epirub
icin and cisplatin produced a biochemical response (>50% decrease in tumor
marker) in 32% of patients, symptomatic improvement in 38%, and a response
in measurable and evaluable disease sites in 14%. Toxicities were mainly he
matologic, with 77% and 41% >grade 2 neutropenia and thrombocytopenia, resp
ectively. Greater than grade 2 toxicities were: cardiac (three), renal seco
ndary to sepsis (one), nausea and vomiting (two), weakness (one), mucositis
(one), and diarrhea (one). The combination of epirubicin and cisplatin was
associated with manageable toxicities in this elderly population; however,
antitumor activity was marginal in this disease. Participation in clinical
trials should continue to be offered to patients with hormone-refractory m
etastatic prostate cancer.