[A prospective randomized trial comparing epirubicin and doxorubicin in advanced or recurrent breast cancer]

A randomized clinical trial comparing epirubicin (EPI) and doxorubicin (DX) was conducted in patients with advanced or recurrent breast cancer. The dosage employed was 60 mg/m2 for EPI and 40 mg/m2 for DX at intervals of three weeks. There were 40 patients entered into the EPI group and 39 into the DX group. Background factors analysed were well balanced in both groups. The response rate was 56.3% in the EPI group (5 CR and 13 PR among 32 evaluable patients), and 35.5% in the DX group (1 CR and 10 PR among 31 evaluable patients), and the difference between both groups was statistically significant (P less than 0.05) by U-test. The response duration and time to response showed no significant difference between both groups. The incidences and grades of hematologic and non-hematologic toxicities were nearly identical. We conclude that EPI is a useful drug for the treatment of advanced breast cancer.