Gemcitabine plus capecitabine combination in metastatic breast cancer patients previously treated with anthracyclines and taxanes.

Background: Treatment of patients with metastatic breast cancer (MBC) exposed to anthracyclines and taxanes is challenging. Effective and well-tolerated regimens are required. Gemcitabine plus capecitabine combination was assessed in MBC patients pretreated with anthracyclines and taxanes.

Methods: A total of 31 patients treated between November 2004 and September 2005 were retrospectively evaluated in 4 institutions. The median age was 48 years (range 29-77). The patients were given gemcitabine 1,000 mg/m(2) on days 1 and 8, and capecitabine 1,500 mg/m(2) twice daily on days 1-14 every 3 weeks.

Results: A total of 160 cycles of chemotherapy were administered with a median of 5 cycles per patient (range 2-12). Three patients achieved a partial response (10%) and 8 patients (26%) stable disease. The median time to disease progression was 6 months (95% CI 5-7), with a median survival of 18 months (95% CI 15-21) at a median follow-up of 16 months (range 2-28). One-year and 2-year survival rates were 67 and 28%, respectively. Grade 3-4 toxicities were as follows: neutropenia (n = 11, 35%), nausea and vomiting (n = 4, 13%), hand-foot syndrome (n = 2, 6%), anemia (n = 2, 6%), thrombocytopenia (n = 2, 6%) and asthenia (n = 1, 3%).

Conclusions: The combination of gemcitabine plus capecitabine was a tolerable regimen with a mild but comparable survival efficacy to similar regimens in patients with MBC after anthracyclines and taxanes.