[Phase II study of combination chemotherapy with epirubicin, cyclophosphamide and ftorafur in metastatic breast cancer].

Twenty-nine patients with metastatic breast cancer were treated with a combination chemotherapy consisting of Epirubicin 50 mg/m2 IV on day 1, Cyclophosphamide 500 mg/m2 IV on day 1 and Ftorafur 800 mg/day PO every day (ECF therapy). The therapy was repeated every 3 weeks until progression or until a cumulative dose of 700 mg/m2 for epirubicin. Of 25 evaluable patients, there were one with complete response (CR), 11 with partial response (PR), 10 with no change and 3 with progressive disease (PD). The overall response rate (CR + PR) was 48%, and the median duration of response was 47 weeks. The median survival time was 78 weeks for responders and 60 weeks for non-responders, and the difference was statistically significant (p = 0.02). Leukopenia, alopecia, nausea and vomiting were commonly observed, but these side effects were better tolerated than those accompanying ACF therapy. As for cardiotoxicity, there were no acute abnormal E.C.G. changes and no congestive heart failure occurred. The median cumulative dose of Epirubicin was 510 mg/m2. These results indicate that ECF therapy is as effective as ACF therapy for metastatic breast cancer with considerably better tolerability.