This trial compared 6 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with a sequential regimen of 3 cycles of FEC followed by 3 cycles of docetaxel (FEC-D) as adjuvant treatment for women with node-positive or/and T3 or T4 breast cancer. Between January 2006 and January 2010, 657 patients with operable breast cancer were randomly assigned to either FEC every 21 days for 6 cycles, or 3 cycles of FEC followed by 3 cycles of docetaxel, both given every 21 days. Radiotherapy was mandatory for all patients who had undergone breast conserving surgery. Radiation to the chest wall, supraclavicular area, was recommended following mastectomy. Hormone-receptor-positive patients received tamoxifen for 5 years after chemotherapy. The primary end point was 5-year disease-free survival (DFS). Median follow-up was 61 months. Five-year DFS rates were 74 % with FEC and 78 % with FEC-D (P = 0.013). Multivariate analysis adjusted for prognostic factors showed a 17 % reduction in the relative risk of relapse with FEC-D. Five-year overall survival rates were 85 % with FEC and 89.4 % with FEC-D, demonstrating a 27 % reduction in the relative risk of death (P = 0.014). The incidence of grade 3-4 neutropenia, the need for hematopoietic growth factor, and incidence of nausea/vomiting were higher with FEC. Docetaxel was associated with more febrile neutropenia, stomatitis, edema, and nail disorders. Though rare overall, there were fewer cardiac events after FEC-D, attributable mainly to the lower anthracycline cumulative dose. Sequential adjuvant chemotherapy with FEC followed by docetaxel significantly improves disease-free and overall survival in node-positive or/and T3 or T4 breast cancer patients. Although the magnitude of the benefit observed with FEC-D, differences in the toxicity profiles of FEC and FEC-D may influence the choice of treatment for patients.
Adult Aged