Phase II trial of capecitabine and vinorelbine as first-line chemotherapy for metastatic breast cancer patients.

Background: Vinorelbine is one of the most active cytotoxic agents in metastatic breast cancer. Its association with 5-Fluorouracil generates objective responses, varying between 44 and 55%, and improves the tolerance profile. The aim of this multicenter phase II trial was to assess the combination of capecitabine and vinorelbine as first-line chemotherapy in patients with metastatic breast cancer (MBC). Patients and Methods: Thirty patients with MBC received a 3-week cycle combining capecitabine 825 mg/m 2 twice a day on days 1 through 14, with 25 mg/m 2 of vinorelbine on days 1 and 8. Treatment continued until progression, unacceptable toxicity or patient refusal to continue. The median age was 54 years (30- 77) and the median WHO-PS was 1. Twenty patients (67%) received adjuvant chemotherapy including anthracycline and taxanes. Results: Objective responses occurred in 21 patients (70%). Stable disease lasting more than 6 months was observed in six patients (20%). The clinical benefit rate was 90%. The median progression-free survival and overall survival were 10 months and 30.4 months, respectively. The most frequent treatment-related toxicities were: WHO grades 3 and 4 neutropenia (two patients), febrile neutropenia (two patients), grade 3 asthenia (two patients) and grade 3 nausea/vomiting (one patient). No grade 3 hand-foot syndrome was observed. Conclusion: The combination of capecitabine and vinorelbine is an active and safe regimen for first-line treatment of MBC. Despite adjuvant chemotherapy, approximately 40 to 50% of patients will develop recurrent and/or metastatic breast cancer