Comparison of neoadjuvant chemotherapy (NACT) with 5-flurouracil, epirubicin (100mg), cyclophosphamide (FEC100) followed by docetaxel (D) (75mg) versus adriamycin and cyclophosphamide (AC) followed by docetaxel (100mg) in locally advanced breast cancer (LABC): A randomized clinical study.

Authors

null

Smita Kayal

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

Organizations

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry, India, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

Research Funding

No funding sources reported

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 estimatedArm A (ACà D)
N = 74(%)
Arm B (FECàD)
N = 74(%)
p-Value
Median age (in years)4852-
Stage III disease60 (81%)52 (70%)0.18
Successful surgery64 (87%)67 (91%)0.60
pCR23 (31%)25 (34%)0.91
Grade 3/4 neutropenia26 (35%)12(16%)0.01
Febrile neutropenia25 (34%)12 (16%)0.02
Dose modifications07 (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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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy

Track

Breast Cancer

Sub Track

Cytotoxic Chemotherapy

Citation

J Clin Oncol 33, 2015 (suppl; abstr e12002)

DOI

10.1200/jco.2015.33.15_suppl.e12002

Abstract #

e12002

Abstract Disclosures