Gemcitabine plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer.

PURPOSE: To investigate the efficacy and safety of gemcitabine plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer (MBC).

METHODS: Eligible patients received gemcitabine 1,000 mg/m2 on days 1 and 8, and capecitabine 1,000 mg/m2 twice daily on days 1-14. The treatment was repeated every 3 weeks for a maximum of 6 cycles. The primary endpoint was objective response rate (ORR). The secondary endpoint included progression-free survival (PFS), overall survival (OS), and toxicity.

RESULTS: Forty-eight patients with a median age of 72 years (range, 65-83) were included. The ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) was 29.2% (95% confidence interval [CI], 16.3% to 42.1%). After a median follow-up of 17.4 months, median PFS and OS were 6.4 months (95% CI, 5.2-7.6) and 18.0 months (95% CI, 14.8-21.2), respectively. Grade 3 to 4 adverse events included neutropenia (20.8%), asthenia (8.3%), hand-foot syndrome (6.3%), abnormal liver function (6.3%), diarrhea (6.3%), constipation (2.1%) and thrombocytopenia (2.1%). Neutropenic fever occurred in one patient.

CONCLUSIONS: Gemcitabine plus capecitabine are active and safe in elderly patients with anthracycline- and taxane-pretreated MBC.