Comparison of efficacy of neoadjuvant chemotherapy FEC 100 and Docetaxel 75 versus AC and Docetaxel in locally advanced breast cancer: a randomized clinical study.

The aim of the study was to assess and compare the clinical and pathological response and the toxicity profile between neoadjuvant chemotherapy FEC followed by docetaxel versus AC followed by docetaxel in locally advanced breast cancer patients. Between June 2013 and June 2014, 148 patients diagnosed with LABC were randomized into two groups with 74 in each group. Group 1 received AC (adriamycin 60 mg/m(2), cyclophosphamide 600 mg/m(2)) followed by docetaxel 100 mg/m(2) with primary GCSF prophylaxis and group 2 received FEC (5-fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), cyclophosphamide 500 mg/m(2)) followed by docetaxel 75 mg/m(2). MRM/BCS was performed for all patients after NACT and assessed for pathological response. Toxicity profile was assessed according to CTCAE version 4. All baseline parameters were equally matched between the two regimens. 90 % of patients completed NACT and underwent surgery. pCR rates were 31 % in group 1 and 34 % in group 2 without any difference. Any grade of hand-foot syndrome was significantly high in group 1 as compared to group 2. Grade 3 and grade 4 neutropenia and febrile neutropenia were significantly high in group 1 as compared to group 2. Median follow-up was 13.7 months (range, 2.9-25 months). There was no difference in the 2-year PFS between group 1 and group 2 (70.9 vs. 73.8 %, respectively) and OS (87.8 vs. 91.8 %, respectively) in our study population. Chemotherapy with FEC followed by docetaxel can be considered as an optimal neoadjuvant regimen in LABC as compared to AC followed by docetaxel.

RCT Entities:   Population Interventions Outcomes