Neoadjuvant epirubicin with or without sequential docetaxel in treatment of advanced breast cancer: assessment of pathological complete response and chemotherapy tolerability

Objective: To assess the pathological complete response (pCR) rate after neoadjuvant chemotherapy (NC) with anthracyclines with or without taxanes in management of locally advanced breast cancer (LABC). Method: Patients with LABC were included. A cohort received four cycles of 5-fluorouracil (FEC] (FEC 500 mg/m(2), epirubicin 75 mg/m(2), cyclophosphamide 500 mg/m(2)) every 3 weeks followed by four cycles of docetaxel (D) 75 mg/m(2) as 1 h infusion intravenous every 3 weeks. Another cohort received six cycles of FE100C (500, 100 and 600 mg/m(2)). The chemotherapy was followed by surgery and radiotherapy. Results: There was no statistically significant difference in overall response rate (ORR) (ORR: 78.5 vs. 85%; p = 0.299) and clinical complete response (cCR) (cCR: 20.6 vs. 33.3%; p = 0.103) for 4FEC -> 4D compared to 6FE100C, respectively. Instead, there was a statistically significant improved rate of pCR (30.2 vs. 16.7%; p = 0.049) and negative axillary lymph nodes (51.6 vs. 35%; p = 0.03) for 4FEC -> 4D compared to 6FE100C, respectively. Serious toxicity was low and non-significant in both cohorts. The logistic regression multivariate models showed that main significant predictors to obtain a pCR were 4FEC -> 4D NC (odds ratio [OR]: 2.7: p = 0.019) and stage IIIA (OR: 3.8; p = 0.002). Conclusion: This study showed that 4FEC -> 4D regimen with conventional dose is highly active and well tolerated in patients with LABC in our hospital.