Combination chemotherapy with docetaxel plus vinorelbine in metastatic breast cancer patients with prior exposure to anthracyclines

Purpose: To evaluate the anti-tumor activity and tolerance of docetaxel plu s vinorelbine in metastatic breast cancer (MBC) patients previously treated with anthracyclines. Patients and methods: Fifty patients with MBC were treated with docetaxel 7 5 mg/m(2) (subsequently reduced to 60 mg/m(2)) plus vinorelbine 30 mg/m(2) (subsequently reduced to 24 mg/m(2)), both on day 1, every 3 weeks, for a m aximum of six cycles. All patients had previously received anthracyclines a s adjuvant treatment (< 12 months disease-free interval) or first-line ther apy for MBC. Thirty-seven patients had received at least one prior regimen for MBC. Twenty-five patients had prior high-dose chemotherapy with stem-ce ll rescue. Thirty patients had multiple metastatic sites. Liver and lung di sease were the predominant metastatic site in 31 patients. Results: Forty-nine patients were assessable for response. Nineteen patient s achieved a partial response and four a complete response (overall respons e rate, 46%; 95% confidence interval (95% CI): 32%-60%). Fourteen patients (28%) had stable disease on treatment. Median Kaplan-Meier estimated progre ssion-free and duration of response times are 21 and 29 weeks. Median survi val time is 47 weeks. Hematological dose-limiting toxicity, prompted a 20% dose reduction for both drugs after the first thirteen patients were treate d. Neutropenia greater than or equal to grade 3 occurred in nineteen (34%) patients, neutropenic fever in 15 (7%) courses, and mucositis greater than or equal to grade 3 in 6 (3%) courses. Conclusions: The combination of docetaxel plus vinorelbine on day 1 every 3 weeks is feasible and active in MBC patients with prior anthracycline expo sure. This regimen is safe, well-tolerated and convenient for the patients.