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Background <p>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.</p> Methods <p>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.</p> Results <p>Median OS was 25.9 months [95% CI: 23.7, 28.4] (<i>N</i> = 876), compared to 46.7 months (<i>N</i> = 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.</p> Discussion <p>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.</p>

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Abemaciclib plus fulvestrant in treating hormone-receptor positive, HER2-negative advanced breast cancer—comparing real-world outcomes in England to the MONARCH-2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月30日

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  • Jack Anderson,
  • Sarah Lawton,
  • Katherine Thackray,
  • Emma Kipps

摘要

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.