Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India
Smita Kayal , Dubashi Biswajit , Sunu Lazar Cyriac , Bhawana Badhe , Kadambari D , Deepak Bharathi , Swaruparani D , Gopinath S , Dhanraj K
Background: NACT in LABC improves the rate of breast conservation and pathological complete response (pCR), which could be a surrogate marker for chemo responsiveness and survival. In this study we compared pCR and toxicity between two regimens in a resource limited setting. Methods: Newly diagnosed LABC cases were enrolled between December 2012 and June 2014 and randomized into two arms. Arm A was AC (Adriamycin 60mg/m2, Cyclophosphamide 600mg/m2) 3 weekly for 4 cycles, followed by Docetaxel 100mg/m2 (with GCSF prophylaxis) for 3 weekly for 4 cycles and arm B was FEC 100 (5-flurouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) x 3 cycles Q 3 weekly followed by Docetaxel 75mg/m2 x 4 cycles Q 3 weekly. The primary end points were pCR and toxicity profile. Secondary endpoints were progression free survival (PFS) and overall survival(OS). Results: A total of 148 patients were enrolled (74 in each arm), treated and followed up for at least 6 months. Results are presented in table 1. No significant difference was observed between clinical and MRI documented complete response with pCR between the groups. In multivariate and univariate analysis none of the parameter (Age, Stage, Grade, Nodal status, hormonal and Her2 status) had a significant influence on the response in both the groups. Other grade 3 and 4 toxicities were comparable in both arms. Toxicity deaths were 2% in both groups. Conclusions: FEC(100) +D as neoadjuvant chemotherapy in LABC has similar pCR rates but with a significantly favorable toxicity profile as compared to AC+D.
Parameters estimated | Arm A (ACà D) N = 74(%) | Arm B (FECàD) N = 74(%) | p-Value |
---|---|---|---|
Median age (in years) | 48 | 52 | - |
Stage III disease | 60 (81%) | 52 (70%) | 0.18 |
Successful surgery | 64 (87%) | 67 (91%) | 0.60 |
pCR | 23 (31%) | 25 (34%) | 0.91 |
Grade 3/4 neutropenia | 26 (35%) | 12(16%) | 0.01 |
Febrile neutropenia | 25 (34%) | 12 (16%) | 0.02 |
Dose modifications | 07 (10%) | 05 (7%) | 0.7 |
PFS (mean follow-up period = 23.9 months) | 95.6% | 97.9% | 0.34 |
OS (mean follow-up period = 21.3 months) | 82.4% | 85.1% | 0.34 |
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