Anthracycline-Free Adjuvant Treatment in Early TOP2A-Normal Breast Cancer
The Danish phase III DBCG 07-READ trial has shown no difference in disease-free survival with adjuvant docetaxel/cyclophosphamide vs epirubicin, cyclophosphamide, and docetaxel in patients with early TOP2A-normal breast cancer. These trial results were reported in the Journal of Clinical Oncology by Ejlertsen et al.
Study Details
In the open-label trial, 2,012 patients with ≥ 1 high-risk factor were randomized between June 2008 and December 2012 to receive six cycles of docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks (DC group, n = 1,011) or three cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) followed by three cycles of docetaxel (100 mg/m2; EC-D group, n = 1,001). The primary endpoint was disease-free survival after a median of 5 years of follow-up on intent-to-treat analysis.
Efficacy Outcomes
The current analysis was conducted 5 years after closure of recruitment, with a median estimated potential follow-up of 69 months for disease-free survival and 71 months for overall survival. Five-year disease-free survival was 87.9% in the EC-D group vs 88.3% in the DC group (hazard ratio [HR] = 1.00, P = 1.00). There were no significant differences in 5-year distant disease–free survival (HR = 1.12, P = .40) or overall survival (HR = 1.15, P = .41). A significant interaction between menopausal status and treatment group was observed for disease-free survival (P = .04 for interaction) but not for overall survival (P = .07 for interaction). Patients with grade 3 tumors had the most benefit from DC, and those with grade 1 and 2 tumors had the most benefit from EC-D (P = .02 for interaction for disease-free survival; P = .03 for interaction for overall survival).
Adverse Events
Stomatitis, myalgia/ arthralgia, vomiting, nausea, fatigue, peripheral neuropathy, and grade 3 or 4 febrile neutropenia were more common in the EC-D group, and edema was more common in the DC group.
The investigators concluded: “This study provides evidence to support no overall outcome benefit from adjuvant anthracyclines in patients with early TOP2A-normal breast cancer.”
The study was supported by the Danish Breast Cancer Cooperative Group, the Danish Foundation for Clinical and Experimental Cancer Research, and Sanofi.
Bent Ejlertsen, MD, PhD, of the Danish Breast Cancer Cooperative Group Secretariat, Rigshospitalet, Copenhagen, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
