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Background <p>Cyclin-dependent kinase (CDK) 4/6 inhibitors improve outcomes in hormone receptor–positive, HER2-negative breast cancer, but real-world data on cardiovascular (CV) toxicity are limited.</p> Methods <p>In this single-centre retrospective matched cohort study, women with breast cancer treated with a CDK4/6 inhibitor at University Hospitals Leuven between 2016 and 2022 constituted the&#xa0;index cohort. Age- and BMI-matched women without active cancer, selected from the population-based FLEMENGHO study, constituted the&#xa0;reference cohort. CV events were identified from medical records, and follow-up in the reference cohort was truncated to the maximum follow-up duration of the index cohort to improve comparability.</p> Results <p>Among 536 matched pairs, the index cohort had a significantly higher observed incidence of CV events than the reference cohort (67.7 vs 17.2 per 1,000 person-years; <i>P</i> &lt; 0.0001), including the cardiac composite (28.0 vs 9.6 per 1,000 person-years; <i>P</i> &lt; 0.0001). Venous thromboembolism (11.6% vs 0.75%) and atrial fibrillation/flutter (4.7% vs 1.5%) were more frequent in the index cohort. Coronary events, stroke, and heart failure did not differ significantly. After adjustment for measured baseline CV risk factors, index-cohort membership remained associated with higher risks of CV events (HR, 3.63; 95% CI, 2.57–5.13) and cardiac events (HR, 3.25; 95% CI, 1.97–5.35).</p> Conclusions <p>Women with breast cancer receiving CDK4/6 inhibitors had a substantially higher observed burden of venous thromboembolism and atrial arrhythmias than the age- and BMI-matched population reference cohort without active cancer. These findings support cardiovascular awareness in this population. However, the comparison cannot isolate a drug-specific effect because active malignancy, previous cancer therapies, baseline differences, and surveillance intensity may also contribute.</p> Trial registration <p>This retrospective single-centre matched cohort study was approved by the Ethics Committee UZ/KU Leuven (approval numbers s68763 and s64406). As a retrospective observational study, prospective trial registration was not required.</p> Graphical Abstract <p></p>

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Cardiovascular event burden in women with breast cancer treated with CDK4/6 inhibitors: a retrospective matched cohort study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月4日

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  • Veerle Leenaerts,
  • Nicholas Cauwenberghs,
  • Hans Wildiers,
  • Patrick Neven,
  • Tatiana Kuznetsova,
  • Lucas Van Aelst

摘要

Background

Cyclin-dependent kinase (CDK) 4/6 inhibitors improve outcomes in hormone receptor–positive, HER2-negative breast cancer, but real-world data on cardiovascular (CV) toxicity are limited.

Methods

In this single-centre retrospective matched cohort study, women with breast cancer treated with a CDK4/6 inhibitor at University Hospitals Leuven between 2016 and 2022 constituted the index cohort. Age- and BMI-matched women without active cancer, selected from the population-based FLEMENGHO study, constituted the reference cohort. CV events were identified from medical records, and follow-up in the reference cohort was truncated to the maximum follow-up duration of the index cohort to improve comparability.

Results

Among 536 matched pairs, the index cohort had a significantly higher observed incidence of CV events than the reference cohort (67.7 vs 17.2 per 1,000 person-years; P < 0.0001), including the cardiac composite (28.0 vs 9.6 per 1,000 person-years; P < 0.0001). Venous thromboembolism (11.6% vs 0.75%) and atrial fibrillation/flutter (4.7% vs 1.5%) were more frequent in the index cohort. Coronary events, stroke, and heart failure did not differ significantly. After adjustment for measured baseline CV risk factors, index-cohort membership remained associated with higher risks of CV events (HR, 3.63; 95% CI, 2.57–5.13) and cardiac events (HR, 3.25; 95% CI, 1.97–5.35).

Conclusions

Women with breast cancer receiving CDK4/6 inhibitors had a substantially higher observed burden of venous thromboembolism and atrial arrhythmias than the age- and BMI-matched population reference cohort without active cancer. These findings support cardiovascular awareness in this population. However, the comparison cannot isolate a drug-specific effect because active malignancy, previous cancer therapies, baseline differences, and surveillance intensity may also contribute.

Trial registration

This retrospective single-centre matched cohort study was approved by the Ethics Committee UZ/KU Leuven (approval numbers s68763 and s64406). As a retrospective observational study, prospective trial registration was not required.

Graphical Abstract