Anthracycline in Early Breast Cancer: Regimens Offer Similar Outcomes

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Three cycles of epirubicin plus cyclophosphamide followed by docetaxel offered no survival benefits.
Three cycles of epirubicin plus cyclophosphamide followed by docetaxel offered no survival benefits.

Three cycles of epirubicin plus cyclophosphamide (EC) followed by docetaxel (EC-D) offered no survival benefits over 6 cycles of docetaxel plus cyclophosphamide (DC) for women with early-stage, high-risk, node-positive, ER-negative, HER2-positive breast cancer without TOP2A alterations, according to findings from the randomized phase 3 READ clinical trial (ClinicalTrials.gov Identifier: NCT00689156), presented at the 2016 San Antonio Breast Cancer Symposium.1

“EC followed by docetaxel did not demonstrate any overall significantly-superior efficacy compared to DC in patients with early and TOP2A-normal breast cancer,” reported lead study author Bent Ellertsen, MD, PhD, on behalf of the Danish Breast Cancer Cooperative Group. “Patients more often reported adverse events following EC-D as compared to DC.”

Findings suggest that EC-D benefits might be greater for patients with grade 1-2 tumors and in postmenopausal women, while DC might be associated with superior outcomes among premenopausal women and those with grade 3 tumors, Dr Ellertsen said.

Anthracyclines are topoisomerase II inhibitors. Although clinical trial experience has suggested an absolute 3% benefit for anthracycline-based chemotherapy in survival for patients with early breast cancer, this might be because a small subset of patients who experience “a much larger benefit,” Dr Ellertsen noted.

Several candidate tumor-specific mechanisms could explain that situation. “HER2 amplification, TOP2A alteration, CEP17 duplication and TIMP1 immunoreactivity have retrospectively been associated with benefit [from anthracyclines] either alone or in combination,” Dr Ellertsen said.

The study authors evaluated the outcomes among patients with TOP2A-normal breast tumors.

The READ Trial stratified 5160 women with TOP2A-tested early breast cancer: 835 with altered TOP2A status and 2012 women with normal TOP2A-status early breast cancer. Women with normal-TOP2A status were randomly assigned to receive EC-D or DC, with 994 of 1001 women in the EC-D group receiving the allocated treatment and 1006 of 1011 women assigned to the DC study group receiving allocated treatment, Dr Ellertsen reported.

At a follow-up of 5 years, neither disease-free survival (DFS) nor overall survival (OS) differed between study groups. Subgroup analysis results for DFS suggested possible associations favoring EC-D for tumor grades 1 and 2, and favoring DC for tumor grade 3. Subgroup analysis for OS suggested that grade 2 tumors are best treated with EC-D.

RELATED: Larger Social Networks Linked With Better Breast Cancer Survival

Patient-reported adverse events included mucositis (grade 3-4 affecting 25% of patients in the EC-D group and 11% in the DC group; myalgia/arthralgia (43% vs 33%, respectively); peripheral neuropathy (12% vs 8%, respectively), and fatigue (30% vs 24%, respectively).

Reference

  1. Ejlertsen B, Tuxen MK, Jakobsen EH, et al. DBCG 07-READ: A randomized phase III trial comparing six cycles of docetaxel and cyclophosphamide (DC) to three cycles of epirubicin and cyclophosphamide followed by three cycles of docetaxel (EC-D) in patients with early breast cancer. Paper presented at: 39th San Antonio Breast Cancer Symposium; Dec 2016; San Antonio, TX.

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