Objective: This phase II study was designed to evaluate the effects of vinorelbine (VRL) and capecitabine (CAP) as second-line combination chemotherapy in patients with advanced breast cancer (ABC) previously treated with anthracyclines and/or taxanes.
Methods: Treatment consisted of VRL 25 mg/m(2) administered on days 1 and 8 of a 21-day treatment cycle, along with oral CAP 825 mg/m(2) twice daily for 14 days, followed by 7 days of rest.
Results: 50 patients were enrolled and 48/50 (96.0%) patients were assessable for response. The median time to progression (TTP) and overall survival (OS) of the patients were 5.0 (95% confidence interval, CI, 2.1-7.9 months) and 12.0 months (95% CI, 8.0-16.0 months), respectively. The objective response rate was 26.0% (95% CI, 13.8-38.2%) with 1 confirmed complete response and 12 partial responses. The most frequent hematological adverse event was neutropenia of grade 3 and 4 in 5 (10.4%) and 2 patients (4.2%), respectively. Grade 3 stomatitis, asthenia, and diarrhea were observed in 1 (2.1%), 2 (4.2%) and 3 (6.3%) patients, respectively.
Conclusion: The combination of VRL and CAP is feasible as second-line chemotherapy in patients with ABC previously treated with anthracyclines and/or taxanes, with efficacy being comparable to other available combination regimens.
Copyright © 2011 S. Karger AG, Basel.