Capecitabine plus vinorelbine combination therapy in patients with metastatic breast cancer pretreated with anthracyclines and/or taxanes

ABSTRACT

To determine efficacy and safety of capecitabine plus vinorelbine in metastatic breast cancer [MBC] patients who relapse after adjuvant and/or first line chemotherapy [including anthracyclines and/or taxanes]. From April 2007 to March 2003, 26 eligible patients were recruited. Patients were treated by Vinorelbine in a dose of 25 mg/m[2] administered on days 1 and 8 every 3 weeks with Capecitabine orally twice daily [1000 mg/m[2]] for 14 consecutive days starting on day 1 of the cycle. The median age was 56 years [range 31-67]; ECOG PS 0-1, [9-12]; ER/PR +ve [19]; prior chemotherapy anthracvcyclines/taxanes [26/8]. After chemotherapy the overall response rates were 48% [1 CR and 11PR] [95% confidence interval [CI], 35.9-59.7]. In additional seven patients [28%] showed disease stabilization. The median time to disease progression was seven months and median overall survival was 17.5 months. Myelosuppression was the predominant toxicity. Toxicities included grades III and IV neutropenia in 7 [2 7%] and 3 [11.5%] patients respectively, and only one patient developed febrile neutropenia. Grade III hand-foot syndrome occurred only in One patient. Other nonhematologic toxicities were minimal and manageable. This study demonstrated that capecitabine plus vinorelbine combination was effective and well tolerated in MBC patients even after failure of anthracycline-and/or taxane-containing regimens