Paclitaxel, epirubicin and cyclophosphamide combination in first-line treatment of metastatic breast cancer: a dose escalation study.

The purpose of this study was to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of combined paclitaxel, epirubicin and cyclophosphamide in patients with metastatic breast cancer. The dose of paclitaxel was planned to be escalated from 150 to 225 mg/m(2)in 25 mg/m(2) steps, while the doses of epirubicin and cyclophosphamide were fixed at 50 and 500 mg/m(2), respectively. Because of DLT, the dose of paclitaxel was maintained at 200 mg/m(2) and the dose of epirubicin was increased to 90 mg/m(2). The MTD was reached at a dose of paclitaxel and epirubicin of 200 and 75 mg/m(2), respectively. DLT were mainly febrile neutropenia and grade 4 neutropenia lasting for > or =7 days. Among the 35 evaluable patients, there were 2 (6%) complete responses and 19 (53%) partial responses for an overall response rate of 59% [95% confidence interval (CI): 41-74%]. The triplet paclitaxel/epirubicin/cyclophosphamide is an effective and well-tolerated combination worthy of further investigation in the treatment of patients with metastatic breast cancer.