Evidence map›Paper›PMID 42400066›Full record

ArticleCardio-oncology (London, England)2026

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

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

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Article in Cardio-oncology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Veerle Leenaerts *Department of Cardiovascular Sciences, University of Leuven, Faculty of Medicine, Louvain, Belgium. veerle.leenaerts@uzleuven.be.
Nicholas Cauwenberghs *Department of Cardiovascular Sciences, University of Leuven, Faculty of Medicine, Louvain, Belgium.
Hans WildiersDepartment of Oncology, University of Leuven, Faculty of Medicine, Louvain, Belgium.
Patrick NevenDepartment of Oncology, University of Leuven, Faculty of Medicine, Louvain, Belgium.
Tatiana KuznetsovaDepartment of Cardiovascular Sciences, University of Leuven, Faculty of Medicine, Louvain, Belgium.
Lucas Van AelstDepartment of Cardiovascular Sciences, University of Leuven, Faculty of Medicine, Louvain, Belgium. lucas.vanaelst@uzleuven.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCyclin-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.

methodsIn 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.

resultsAmong 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).

conclusionsWomen 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 registrationThis 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.

Indexed as

Atrial fibrillationBreast cancerCardiovascular toxicityCDK4/6 inhibitorsReal-world dataThromboembolic events

Identifiers

PMID42400066
PMCPMC13613799

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.