Abemaciclib plus fulvestrant in treating hormone-receptor positive, HER2-negative advanced breast cancer—comparing real-world outcomes in England to the MONARCH-2 trial
Menée en Angleterre, cette étude évalue l'efficacité, du point de vue de la survie globale, de la survie sans traitement et de la survie sans chimiothérapie, d'un traitement combinant abémaciclib plus fulvestrant chez les patientes atteintes d'un cancer du sein HR+ HER2-, puis compare les résultats de l'essai MONARCH-2 aux données en vie réelle
Background: Abemaciclib plus fulvestrant was approved in Europe following publication of the MONARCH-2 trial and recommended to enter the NICE Cancer Drugs Fund for HR+/HER2− advanced breast cancer. We aimed to assess MONARCH-2 generalisability to England clinical practice using real-world NHS trust data.
Methods: We identified patients receiving abemaciclib plus fulvestrant from April to December 2019 in the NHS England Blueteq and Systemic Anti-Cancer Therapy data, with follow-up to March 2024. We calculated overall survival (OS) from treatment initiation until death, and treatment-free survival (TFS) and chemotherapy-free survival (CFS) from initiation until post-discontinuation treatment or death (restricting CFS to chemotherapy). We measured outcomes using Kaplan–Meier methodology and compared to MONARCH-2.
Results: Median OS was 25.9 months [95% CI: 23.7, 28.4] (N = 876), compared to 46.7 months (N = 446) in MONARCH-2. Differences in gender, age and performance status did not explain OS differences. Median TFS was 11.6 months [95% CI: 10.3, 12.5] compared to a median PFS of 16.9 months in MONARCH-2. Median CFS was 15.3 months [95% CI: 13.8, 16.7], compared to 25.5 months in MONARCH-2.
Discussion: MONARCH-2 trial data are not generalisable to this real-world cohort, which had notably shorter OS, TFS and CFS that could not be explained by differences in measured patient characteristics.
British Journal of Cancer , article en libre accès, 2026