FEC-100 Not Superior to Adriamycin + Cyclophosphamide in Node-Negative Breast Cancer

Share this content:
FEC-100 does not yield improved outcomes over standard doxorubicin with cyclophosphamide.
FEC-100 does not yield improved outcomes over standard doxorubicin with cyclophosphamide.

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.

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.

Reference

  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.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs