Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: A multicenter phase II study

Purpose: The goal of this multicenter, open-label phase II study was the clinical evaluation of combination therapy with the oral fluoropyrimidine capecitabine and the taxane paclitaxel in patients with metastatic breast cancer (MBC). Patients and Methods: Forty-seven patients with MBC received oral capecitabine at 1,650 mg/m²/d (825 mg/m² twice daily) on days 1 through 14, and intravenous infusion of paclitaxel at 175 mg/m ² on day 1 of each 21-day treatment cycle. Treatment continued until disease progression, intolerable toxicity, or patient's decision to discontinue. Patients (35 to 76 years old) had a median Karnofsky performance status of 90%. Forty-four patients (94%) received study treatment as first-line therapy for metastatic disease. Results: Objective responses occurred in 24 (51%) patients; seven (15%) complete responses and 17 (36%) partial responses. Stable disease lasting 180 days or more was observed in nine (19%); the clinical response rate was 70%. Median duration of response was 12.6 months, median time to disease progression was 10.6 months, and median overall survival time was 29.9 months. The most common treatment-related adverse events, regardless of severity, were alopecia, hand-foot syndrome, nausea, and fatigue. Neutropenia (15%), alopecia (13%), and hand-foot syndrome (11%) were the only grade 3 or 4 treatment-related adverse events that occurred in more than 10% of patients. Conclusion: The combination of capecitabine plus paclitaxel is a highly active and generally well-tolerated regimen for first-line treatment of MBC.