Adjuvant Docetaxel and Cyclophosphamide With or Without Epirubicin for Early Breast Cancer: Final Analysis of the Randomized DBCG 07-READ Trial.

Abstract

The primary analysis of the DBCG 07-READ trial reported in 2017 provided evidence of no overall benefit from adjuvant anthracyclines in patients with early <i>TOP2A</i> normal breast cancer in disease-free survival (DFS), distant disease-free survival (DDFS), or overall survival (OS). We performed a protocol-scheduled analysis of DDFS, DFS, and OS on the basis of 10-year follow-up. Full details on incident heart failure (HF) and second cancers were presented. Patients in the intention-to-treat population assigned to epirubicin and cyclophosphamide followed by docetaxel (EC-D) had longer DDFS (adjusted hazard ratio [HR], 0.79 [95% CI, 0.64 to 0.98]; <i>P</i> = .03) and DFS (HR_Adjusted, 0.83 [95% CI, 0.69 to 0.99]; <i>P</i> = .04) than patients assigned to docetaxel and cyclophosphamide (DC). There was no statistically significant difference in mortality rates. The 10-year cumulative risk of HF was 2.1% (95% CI, 1.4 to 3.3) with EC-D and 1.1% (95% CI, 0.6 to 2.0) with DC (HR_Unadjusted, 2.12 [95% CI, 1.03 to 4.35]; <i>P</i> = .04). In conclusion, anthracycline followed by docetaxel improved outcome compared with DC in patients with <i>TOP2A</i> normal early breast cancer, and no clinical value of <i>TOP2A</i> testing was shown. The risk of HF was doubled in patients receiving anthracycline; however, overall, the risk of HF was low.