RESUMEN
BACKGROUND: Breast cancer is the most common type of cancer in women worldwide. In Mexico, >34% of patients are in locally advanced stages at the time of diagnosis. Neoadjuvant chemotherapy is administered to control local disease, make surgical resection possible and increase the possibility of breast tissue conservation. METHODS: We performed a double-blind, randomized clinical trial in patients with locally advanced breast cancer (stages IIB and IIIA) with two therapy schemes; 5-fluorouracil-epirubicin-cyclophosphamide (control group) vs. docetaxel-epirubicin (study group). Both were indicated in three preoperative cycles, and patients were submitted afterwards to surgery. Pathological response was measured. RESULTS: Forty one patients were included in our study. They were distributed in two homogeneous groups: 21 in the control group and 20 in the study group. Dimensional pathological response was higher in the study group than in the control one (p <0.05). Five patients in the control group and ten patients of the study group experienced complete pathological response (p <0.05). The most common secondary events were leucopenia, neutropenia and fever. Morbidity, number of lymph nodes, disease-free survival and general survival did not show significant differences between groups. No mortality was reported during a minimum follow-up of 28 months. CONCLUSIONS: Our results confirm the effectiveness of docetaxel-epirubicin to obtain complete pathological response. Neoadjuvant therapy has been shown to increase the pathological response when a taxane is added to an anthracycline. This combination presented more secondary events, but they can be effectively managed medically. Neoadjuvant docetaxel-epirubicin followed by surgery is an appropriate regimen for patients with locally advanced breast cancer.