Epirubicin/vinorelbine as first line therapy in metastatic breast cancer.

This study was aimed at investigating the toxicity and activity of the combination epirubicin and vinorelbine in chemotherapy-naive patients with metastatic breast cancer. Fifty-one patients with measurable or evaluable metastatic breast cancer entered the study. The regimen consisted of epirubicin 90 mg/m2 as a slow i.v. infusion on day 1, followed by vinorelbine 25 mg/m2 by 30-minute intravenous infusion on days 1 and 8; the courses were repeated every 21 days for a maximum of 8 cycles. All the patients were assessable for toxicity and 47 were evaluable for response according to the World Health Organization (WHO) criteria. Objective responses were observed in 33 out of 47 evaluable patients (70.2\%; 95\% C.I. 55.1\%-82.6\%) with 4 complete (8.5\%) and 29 partial responses (61.7\%); 11 patients had stable disease (23.4\%) and 3 patients progressed while on treatment. The median time to progression was 10 months (range 1-21) and the median overall survival was 23 months (range 2 - 32+). Neutropenia was the most frequent toxicity: a grade 4 neutropenia (WHO) was reported in 70\% of 252 courses with a median duration of 3 days (range 1-6). Seventeen episodes of febrile neutropenia were observed but only 1 patient required hospital admission. Other hematologic toxicities were negligible. One patient experienced a paralytic ileus requiring hospitalization; no peripheral neuropathy such as muscle weakness or paresthesia was observed. No treatment-related cardiotoxicity was reported. The encouraging response rate achieved with epirubicin/vinorelbine, the easily manageable toxicities of the combination, and its feasibility in an outpatient setting make this combination worthy of further comparative trials with standard regimens.