To assess and compare the clinical & pathological response between neoadjuvant chemotherapy FEC followed by Docetaxel versus AC followed by Docetaxel in locally advanced breast cancer patients. To assess and compare the toxicity profile between the above mentioned regimen.
Between Dec 2012 and June 2014, 148 patients diagnosed with LABC were randomized into 2 groups with 74 in each group. Each group received NACT followed by surgery. Group 1 received AC (Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2) followed by Docetaxel 100 mg/m2 with primary GCSF prophylaxis and group 2 received FEC (5-fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) followed by Docetaxel 75 mg/m2 for 4 cycles every 3 weekly. MRI mammogram was performed before and after NACT. After completing all the chemotherapy, study group patients were subjected to Modified radical mastectomy or Breast conservation surgery which was then followed by evaluation of pathological response. Toxicity profile was compared between the treatment groups according to CTCAE (Common Toxicity Criteria for Adverse Events) version-4. Survival analysis was done using Kaplan Meier curve.
Ninety percent 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 & 4 neutropenia and febrile neutropenia was 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 two 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 without the use of primary GCSF prophylaxis can be considered as an optimal neoadjuvant regimen in LABC, which has comparable efficacy with AC x 4 cycles in terms of pathological complete response rates and decreased toxicity. Whether pathological complete response will translate into a meaningful progression-free and overall survival requires longer follow up.
Clinical trial identification
All authors have declared no conflicts of interest.