Efficacy and toxicity of Trastuzumab and Paclitaxel plus Capecitabine in the first-line treatment of HER2-positive metastatic breast cancer.

PURPOSE: Combinations of trastuzumab with paclitaxel or capecitabine are effective therapies in human epidermal growth factor 2 (HER2)-positive metastatic breast cancer (MBC). This retrospective study evaluated the efficacy and toxicity of trastuzumab and paclitaxel plus capecitabine in the first-line therapy for patients with HER2-positive MBC.

METHODS: A total of 40 patients with HER2-positive MBC treated between January 2008 and January 2011 were evaluated retrospectively in 6 institutions. Three patients with performance score of 3 who died before response assessment were excluded from the study. The patients were given trastuzumab 8 mg/kg loading dose followed by then 6 mg/kg dose on day 1 and paclitaxel 175 mg/m(2) on day 1 plus capecitabine 825 mg/m(2) twice daily on days 1-14 every 3 weeks.

RESULTS: A total of 287 cycles of chemotherapy were administered with a median of 8 treatment cycles per patient (range 3-12). Median follow-up period was 24.7 months (range 4.7-51). There were 9 patients (24.3 %) with complete responses, 21 (56.8 %) with partial responses, 4 (10.8 %) with stable disease and 3 (8.1 %) with progressive disease resulting in an overall response rate (ORR) of 81.1 %. Median progression-free survival and overall survival were 14 and 38.4 months, respectively. Rates of grade 3 adverse events were neutropenia (n = 4, 10.8 %), cardiac dysfunction (n = 1, 2.7 %), hand-foot syndrome (n = 2, 5.4 %), nausea (n = 2, 5.4 %), vomiting (n = 2, 5.4 %), fatigue (n = 1, 2.7 %), diarrhea (n = 1, 2.7 %), neuropathy (n = 1, 2.7 %) and alopecia (n = 1, 2.7 %).

CONCLUSIONS: Combination of trastuzumab and paclitaxel plus capecitabine is an effective and well-tolerated regimen in the first-line therapy for women with HER2-positive MBC.