In patients with node-positive early breast cancer, invasive disease-free survival, but not overall survival, was significantly superior for those who received the adjuvant standard schedule epirubicin plus cyclophosphamide followed by docetaxel (EC-T) than for those who received the experimental epirubicin plus docetaxel followed by capecitabine (ET-X) regimen, a new study published online ahead of print in the Journal of Clinical Oncology has shown.1
Because capecitabine is an active drug in metastatic breast cancer, researchers sought to evaluate the integration of capecitabine into an adjuvant regimen of epirubicin and docetaxel for patients with node-positive early breast cancer.
“We tried to see if introducing capecitabine in the adjuvant therapy of breast cancer could be of interest,” said lead author Miguel Martin, MD, PhD, of the Instituto de Investigación Sanitaria Gregorio Marañón at Universidad Complutense in Spain, in an interview with Cancer Therapy Advisor.
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For the study, researchers enrolled 1,384 patients who had undergone surgery for T1-3/N1-3 breast cancer. Participants were randomly assigned to receive epirubicin 90 mg/m2 intravenously plus cyclophosphamide 600 mg/m2 intravenously for 4 cycles, followed by docetaxel 100 mg/m2 intravenously for 4 cycles, or epirubicin 90 mg/m2 intravenously plus docetaxel 75 mg/m2 intravenously for 4 cycles, followed by capecitabine 1,250 mg/m2 orally twice daily on days 1 to 14 for 4 cycles. Both regimens were administered in 3-week cycles.
Patients with hormone receptor-positive tumors then received tamoxifen 20 mg once daily or an aromatase inhibitor for 5 years, or received the aromatase inhibitor sequentially with tamoxifen.