SAN ANTONIO—FEC-100 (5-fluorouracil epirubicin, and cyclophosphamide) does not yield better outcomes than standard doxorubicin (adriamycin) plus cyclophosphamide (AC) therapy in women with lymph node–negative breast cancer, and is associated with increased toxicity, according to randomized phase 3 clinical study findings presented at the 2014 San Antonio Breast Cancer Symposium.

“We found absolutely no difference at all between study arms” in terms of disease-free [DFS] and overall survival [OS], reported study coauthor Charles E. Geyer, Jr., MD, FACP, of the National Surgical Adjuvant Breast and Bowel Project (NSABP) and University of Pittsburgh Medical Center, in Pittsburgh, PA. “Results do not support use of 6-cycle anthracycline-based regimens in node-negative breast cancer.”

A total of 2,722 patients with T1-T3, pN0 breast cancer were randomly assigned 1:1 to receive either doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 3 weeks for four cycles or 5-FU (500 mg/m2), epirubicin (100 mg/m2), and cyclophosphamide (500 mg/m2) every 3 weeks for 6 cycles.

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At a median follow-up of 82.8 months, DFS was 82% in both groups, and OS was 91% among patients in the AC arm and 92% among those in the FEC arm.

 Overall, grade 3 and 4 expected toxicities including fatigue and febrile neutropenia were more frequent in the FEC arm (fatigue: 3.6% vs. 8.4%, febrile neutropenia: 3.7% vs. 9.4%), Dr. Geyer reported. Grade 3 left ventricular dysfunction occurred in one patient in each treatment arm.

“FEC-100 x 6 did not improve the primary endpoint of DFS or secondary endpoint of OS relative to AC x 4, and toxicities increased with FEC-100” Dr. Geyer concluded.

The study’s financial sponsors included the National Cancer Institute, Pharmacia & Upjohn Co.


  1. Samuel JA, Wilson JW, Bandos H et al. S3-02. Presented at: San Antonio Breast Cancer Symposium 2014. Dec. 9-13, 2014; San Antonio, TX.