As reported in the Journal of Clinical Oncology by Jensen et al, the final analysis of the phase III Danish DBCG07-READ trial showed improved 10-year outcomes with the addition of epirubicin to docetaxel/cyclophosphamide adjuvant therapy in patients with TOP2A-normal breast cancer. The primary analysis of the trial, reported in 2017, showed no benefit to adding the anthracycline in terms of disease-free survival, distant disease–free survival, or overall survival.
Study Details
In the open-label multicenter trial, 2,012 patients with TOP2A-normal tumors were randomly assigned between June 2008 and December 2012 to receive adjuvant therapy with three cycles of epirubicin/cyclophosphamide followed by three cycles of docetaxel (EC-D; n = 1,001) or six cycles of docetaxel/cyclophosphamide (DC; n = 1,011). The current report provides findings in a protocol-scheduled analysis of disease-free survival, distant disease–free survival, and overall survival on the basis of 10-year follow-up.
Key Findings
At 10 years, disease-free survival events had occurred in 217 patients in the EC-D group vs 250 in the DC group (adjusted hazard ratio [HR] = 0.83, 95% confidence interval [CI] = 0.69–0.99, P = .04). Distant disease–free survival events had occurred in 170 patients vs 204 patients (adjusted HR = 0.79, 95% CI = 0.64–0.98, P = .03). No significant difference in overall survival was observed, with death occurring in 147 vs 160 patients (adjusted HR = 0.88, 0.70–1.10, P = .25).
The 10-year cumulative risk of heart failure was 2.1% (95% CI = 1.4%–3.3%) in the EC-D group vs 1.1% (95% CI = 0.6%–2.0%) in the DC group (HR = 2.12, 95% CI = 1.03–4.35, P = .04). Second non-breast primary invasive cancers occurred in 61 patients in the EC-D group and 79 patients in the DC group.
The investigators concluded: “…[A]nthracycline followed by docetaxel improved outcome compared with DC in patients with TOP2A normal early breast cancer, and no clinical value of TOP2A testing was shown. The risk of [heart failure] was doubled in patients receiving anthracycline; however, overall, the risk of heart failure was low.”
Maj-Britt Jensen, MSc, of the Danish Breast Cancer Cooperative Group, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Danish Breast Cancer Cooperative Group, Danish Foundation for Clinical and Experimental Cancer Research, and Sanofi. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
