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Risk of Heart Failure Hospitalization in Patients Treated With Osimertinib: A Population-Based Retrospective Cohort

Yasuhisa Tatebe1, Yuta Tanaka1, Yohei Manabe1

  • 1Department of Pharmacy, Okayama University Hospital, Okayama, Japan.

JACC. Cardiooncology
|September 12, 2025
PubMed
Abstract

Insights

Osimertinib use in non-small cell lung cancer patients is linked to a higher risk of heart failure (HF) hospitalization. Close cardiac monitoring is recommended for patients on this treatment.

Area of Science:

  • Oncology
  • Cardiology
  • Pharmacology

Background:

  • Osimertinib is a targeted therapy for EGFR-mutant non-small cell lung cancer.
  • Previous studies suggest a potential link between osimertinib and heart failure (HF), but risk data is limited.

Purpose of the Study:

  • To investigate the association between osimertinib treatment and the risk of HF hospitalization.
  • To quantify the risk of HF hospitalization in patients receiving osimertinib compared to controls.

Main Methods:

  • Retrospective cohort study utilizing a large Japanese claims database.
  • Patients with lung cancer treated between 2008-2021 were categorized into osimertinib and control groups.
  • Propensity score matching and multivariable analyses were employed to assess HF hospitalization risk.

Main Results:

  • The study included 11,391 patients on osimertinib and 108,144 controls.
  • Osimertinib use was associated with a significantly higher incidence of HF hospitalization (9.9 vs. 4.1 per 1000 person-years).
  • Multivariable analysis revealed a 2.56-fold increased risk of HF hospitalization with osimertinib, persisting after propensity score matching (2.29-fold increased risk).

Conclusions:

  • Osimertinib use is associated with an elevated risk of heart failure hospitalization.
  • Continuous cardiac function monitoring is crucial for patients undergoing osimertinib therapy.
Keywords:
adverse eventscardiotoxicityepidermal growth factor receptor tyrosine kinase inhibitorheart failurelung cancerpharmacotherapypropensity score matching

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