Adjuvant Docetaxel and Cyclophosphamide With or Without Epirubicin for Early Breast Cancer: Final Analysis of the Randomized DBCG 07-READ Trial
Mené sur 2 012 patientes atteintes d'un cancer du sein de stade précoce (durée médiane de suivi : 10 ans), cet essai évalue l'efficacité, du point de vue de la survie sans maladie, de la survie sans maladie à distance et de la survie globale, et la toxicité de l'ajout d'épirubicine à un traitement adjuvant combinant docétaxel et cyclophosphamide
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 (HRAdjusted, 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 (HRUnadjusted, 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. Adding anthracycline to taxane improved distant disease-free survival and doubled heart failure risk in DBCG 07-READ.