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

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 TOP2A 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]; P = .03) and DFS (HR_Adjusted, 0.83 [95% CI, 0.69 to 0.99]; P = .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]; P = .04). In conclusion, anthracycline 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 HF was doubled in patients receiving anthracycline; however, overall, the risk of HF was low.