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 ofdocetaxel plus vinorelbine in metastatic breast cancer (MBC) patientspreviously treated with anthracyclines.Patients and methods:Fifty patients with MBC were treated withdocetaxel 75 mg/m² (subsequently reduced to 60 mg/m²)plus vinorelbine 30 mg/m² (subsequently reduced to 24mg/m²), both on day 1, every 3 weeks, for a maximum of six cycles.All patients had previously received anthracyclines as adjuvant treatment(<12 months disease-free interval) or first-line therapy for MBC.Thirty-seven patients had received at least one prior regimen for MBC.Twenty-five patients had prior high-dose chemotherapy with stem-cell rescue.Thirty patients had multiple metastatic sites. Liver and lung disease were thepredominant metastatic site in 31 patients.Results:Forty-nine patients were assessable for response.Nineteen patients achieved a partial response and four a complete response(overall response rate, 46%; 95% confidence interval (95%CI): 32%–60%). Fourteen patients (28%) had stabledisease on treatment. Median Kaplan–Meier estimated progression-free andduration of response times are 21 and 29 weeks. Median survival time is 47weeks. Hematological dose-limiting toxicity, prompted a 20% dosereduction for both drugs after the first thirteen patients were treated.Neutropenia grade 3 occurred in nineteen (34%) patients,neutropenic fever in 15 (7%) courses, and mucositis grade 3 in 6(3%) courses.Conclusions:The combination of docetaxel plus vinorelbine on day1 every 3 weeks is feasible and active in MBC patients with prioranthracycline exposure. This regimen is safe, well-tolerated and convenientfor the patients.