Phase II multicentre randomised study of docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide in metastatic breast cancer

The purpose of the study was to evaluate the efficacy and safety of docetaxel plus epirubicin (ET) and of 5-fluorouracil plus epirubicin and cyclophosphamide (FEC) as first-line chemotherapy for metastatic breast cancer. A total of 142 patients (intent-to-treat (ITT)) with at least one measurable lesion were randomised to receive docetaxel 75 mg m(−2) plus epirubicin 75 mg m(−2) or 5-fluorouracil 500 mg m(−2) plus epirubicin 75 mg m(−2) and cyclophosphamide 500 mg m(−2) intravenously once every 3 weeks for up to eight cycles. Prophylactic granulocyte-colony-stimulating factor was only permitted after the first cycle, if required. Per-protocol analysis (n=132) gave an overall response rate for ET of 63.1% (95% confidence interval (CI), 50–78%) and for FEC 34.3% (95% CI, 23–47%) after a median seven and six cycles, respectively. Intent-to-treat population (n=142) gave an overall response rate for ET of 59% (95% CI, 47–70%) and for FEC 32% (95% CI, 21–43%) after a median seven and six cycles, respectively. The median response duration for ET was 8.6 months (95% CI, 7.2–9.6 months) and for FEC 7.8 months (95% CI, 6.5–10.4 months). The median time to progression (ITT) for ET was 7.8 months (95% CI, 5.8–9.6 months) and for FEC 5.9 months (95% CI, 4.6–7.8 months). After a median follow-up of 23.8 months, median survival (ITT) for ET and FEC were 34 and 28 months, respectively. Nonhaematologic grade 3–4 toxicities were infrequent in both arms. Haematologic toxicity was more common with ET and febrile neutropenia was reported in 13 patients (18.6%) in the ET group. Two deaths in the ET group were possibly related to study treatment. In conclusion, both ET and FEC were associated with acceptable toxicity. ET is a highly active first-line therapy for metastatic breast cancer.