5-fluorouracil, epirubicin and cyclophosphamide, as first-line cytotoxic chemotherapy for disseminated breast carcinoma. A phase II study

38 patients with metastatic breast carcinoma, refractory to endocrine therapy, received 5-fluorouracil 500 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 IV, on day 1 every 3 weeks for a maximum of 10 cycles. The response rate was 71% (27/38), with 9 complete regressions (24%). Responses were seen at all disease sites including pleural/lung, bone and liver. The median duration of response was 11 months (range 5–33+) and the median survival 18+ months (range 3–34+). The toxicity was acceptable; it was not necessary to delay the next course for more than 1 week or to prophylactically administer granulocyte colony-stimulating factor. Persistent leucopenia and/or thrombocytopenia did not occur. Nausea and/or vomiting were well controlled with the use of a 5-HT3 receptor antagonist. Alopecia was observed in all patients. There were no cases of cardiotoxicity. The promising and significant response rate obtained with this well tolerated schedule makes it suitable for routine clinical use, as first-line chemotherapy in advanced breast carcinoma.