Phase II Study of Capecitabine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2–Overexpressing Metastatic Breast Cancer Pretreated With Anthracyclines or Taxanes
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Media type:
E-Article
Title:
Phase II Study of Capecitabine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2–Overexpressing Metastatic Breast Cancer Pretreated With Anthracyclines or Taxanes
Description:
<jats:sec><jats:title>Purpose</jats:title><jats:p> The oral fluoropyrimidine carbamate, capecitabine, is a highly active and well-tolerated treatment for metastatic breast cancer. In patients treated previously with anthracyclines and taxanes, capecitabine is an approved single-agent therapy. Trastuzumab, a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER-2), is also highly active in HER-2–overexpressing breast cancer. We have conducted a phase II study to confirm activity and feasibility of capecitabine and trastuzumab in combination in HER-2–overexpressing advanced/metastatic breast cancer. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Twenty-seven patients with HER-2–overexpressing metastatic breast cancer previously treated with anthracyclines and/or taxanes received oral capecitabine 1,250 mg/m<jats:sup>2</jats:sup> bid for 14 days followed by a 7-day rest period combined with intravenous trastuzumab 4 mg/kg body weight on day 1 (loading dose) followed by 2 mg/kg weekly. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Capecitabine/trastuzumab treatment achieved objective responses in 12 patients (45%), including complete response in four patients (15%) and partial response in eight patients (30%). Disease was stabilized in an additional nine patients (33%). The median overall survival time was 28 months, and the median progression-free survival time was 6.7 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 pain, hand-foot syndrome, and GI toxicities. Severe myelosuppression was rare and severe alopecia did not occur. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> These data confirm that the combination of capecitabine and trastuzumab is highly active in patients with HER-2–overexpressing anthracycline- and/or taxane-pretreated breast cancer, with only slight restrictions regarding quality of life. </jats:p></jats:sec>