[Clinical efficacy and safety of trastuzumab plus capecitabine as first-line therapy for HER-2 positive metastatic breast cancer]

To evaluate the efficacy and safety of trastuzumab plus capecitabine as first-line therapy for HER-2-positive metastatic breast cancer patients who have previously received anthracyclines and taxanes.The patients who have HER-2-positive breast cancer recurrence and metastasis after treated by anthracyclines and taxanes were enrolled in this study. The patients received trastuzumab (6 mg/kg every 21 days following a loading dose of 8 mg/kg on cycle 1) and capecitabine (2 000 mg/m², days 1 to 14 every 21 days).38 patients were enrolled. The median PFS for trastuzumab plus capecitabine was 8.6 months. The objective response rate (ORR) was 31.6%. Clinical benefit rate (CBR) was 65.8%. The most serious adverse event was leucopenia in one patient. Relatively common hematology toxicity was grade I or II leucopenia and neutropenia. The most common nonhematologic toxicity was hand-foot syndrome (HFS), which observed in 8 patients (21%). The morbidity of grade II and III HFS were 8% and 3% respectively.Trastuzumab plus capecitabine is an effective and safe regimen as first-line treatment for HER-2-positive metastatic breast cancer patients whose cancer is resistant to treatment with anthracyclines and taxanes.