monarchE
Adjuvant Abemaciclib in High-Risk HR+/HER2– Early Breast Cancer
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 5,637 patients with HR+/HER2– node-positive high-risk early breast cancer, two years of abemaciclib added to endocrine therapy reduced invasive disease-free survival events compared with endocrine therapy alone.
N
5 637
Schéma
Open-label RCT
Critère
Invasive disease-free survival
Pertinence
2
Résultat5-yr iDFS 83.6% vs 76.0% (HR 0.680). Distant relapse-free survival HR 0.675.
Johnston SRD, et al. J Clin Oncol. 2020;38(34):3987-3998; Rastogi P, et al. J Clin Oncol. 2024;42(9):987-993. 10.1200/JCO.20.02514
Discussion et critique
First CDK4/6 inhibitor with adjuvant benefit. OS data still maturing; benefit absolute but small in lower-risk subsets.