Trastuzumab plus capecitabine and docetaxel as first-line therapy for HER2-positive metastatic breast cancer: phase II results.

UNLABELLED: In human epidermal growth factor 2 (HER-2)-positive advanced breast cancer, taxanes plus trastuzumab are among the most widely applied options in the first-line setting. The addition of capecitabine to docetaxel significantly improves overall survival in anthracycline-pretreated metastatic breast cancer. We evaluated the efficacy and tolerability of trastuzumab plus capecitabine and docetaxel regimen as first-line therapy. PATIENTS AND METHODS: HER-2-positive patients who had received adjuvant anthracyclines received docetaxel at 75 mg/m(2) on day 1 and capecitabine 950 mg/m(2)/day, days 1-14, every 3 weeks until disease progression or unacceptable toxicity. Trastuzumab was administered at a dose of 6 mg/kg every 3 weeks. Time to progression (TTP) was defined as the primary end point.
RESULTS: Twenty-nine patients were evaluable (median age 52, range 34-70 years). The regimen achieved objective responses in 11 patients (38%), including complete response in three (10.3%) and partial response in eight (27.5%). The median overall survival time was 25.5 months, and the median progression-free survival time was 7.8 months. The safety profile of the combination was favorable and predictable, with a low incidence of grade 3/4 adverse events. The most common adverse events were hand-foot syndrome, and gastrointestinal toxicities. Severe myelosuppression was rare and cardiac toxicity did not occur.
CONCLUSION: These data confirm that the combination of trastuzumab plus capecitabine and docetaxel is highly active in patients with HER-2-overexpressing anthracycline-pretreated breast cancer, offering a significant survival benefit and is well tolerated.