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Background <p>Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have substantially improved outcomes in EGFR-mutated non-small cell lung cancer (NSCLC). However, emerging evidence suggests potential cardiotoxic effects, particularly with third-generation osimertinib, necessitating real-world safety evaluations.</p> Objectives <p>To assess the long-term cardiovascular risk associated with first-line osimertinib compared to earlier-generation EGFR-TKIs in patients with EGFR-mutated NSCLC.</p> Methods <p>We conducted a retrospective cohort study using the TriNetX USA network database, including 4,145 adults with EGFR-mutated NSCLC who received first-line osimertinib (<i>n</i> = 2,610) or earlier-generation EGFR-TKIs (<i>n</i> = 361). After 1:1 propensity score matching, 358 patient pairs were analyzed. The primary outcome was the 5-year cumulative incidence of major composite endpoint (MCE), including arrhythmia, heart failure, ischemic heart disease, and all-cause mortality. Cox proportional hazards models and Kaplan–Meier analyses were applied.</p> Results <p>First-line osimertinib was not associated with an increased overall risk of MCE compared with earlier-generation EGFR-TKIs (HR 0.951; 95% CI: 0.777–1.164; <i>p</i> = 0.627). However, patients aged &lt; 60 years receiving osimertinib exhibited a significantly higher risk of heart failure (HR 2.939; 95% CI: 1.032–8.374), despite lower all-cause mortality in this subgroup.</p> Conclusion <p>Although first-line osimertinib did not increase the overall cardiovascular risk relative to other EGFR-TKIs in real-world practice, younger patients demonstrated an elevated risk of heart failure, warranting enhanced cardiovascular surveillance during treatment.</p>

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Real-world cardiovascular risk comparison of first-line osimertinib and earlier generation EGFR-TKIs in EGFR-mutated NSCLC: a TriNetX USA network analysis

  • 期刊论文

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  • 发表日期：

    2026年4月14日

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  • Wen-Chien Cheng,
  • Chih-Yen Tu,
  • Te-Chun Hsia,
  • Jing-Yang Huang,
  • Cheng-Hsien Hung,
  • Ying-Hsiang Chou,
  • James Cheng-Chung Wei

摘要

Background

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have substantially improved outcomes in EGFR-mutated non-small cell lung cancer (NSCLC). However, emerging evidence suggests potential cardiotoxic effects, particularly with third-generation osimertinib, necessitating real-world safety evaluations.

Objectives

To assess the long-term cardiovascular risk associated with first-line osimertinib compared to earlier-generation EGFR-TKIs in patients with EGFR-mutated NSCLC.

Methods

We conducted a retrospective cohort study using the TriNetX USA network database, including 4,145 adults with EGFR-mutated NSCLC who received first-line osimertinib (n = 2,610) or earlier-generation EGFR-TKIs (n = 361). After 1:1 propensity score matching, 358 patient pairs were analyzed. The primary outcome was the 5-year cumulative incidence of major composite endpoint (MCE), including arrhythmia, heart failure, ischemic heart disease, and all-cause mortality. Cox proportional hazards models and Kaplan–Meier analyses were applied.

Results

First-line osimertinib was not associated with an increased overall risk of MCE compared with earlier-generation EGFR-TKIs (HR 0.951; 95% CI: 0.777–1.164; p = 0.627). However, patients aged < 60 years receiving osimertinib exhibited a significantly higher risk of heart failure (HR 2.939; 95% CI: 1.032–8.374), despite lower all-cause mortality in this subgroup.

Conclusion

Although first-line osimertinib did not increase the overall cardiovascular risk relative to other EGFR-TKIs in real-world practice, younger patients demonstrated an elevated risk of heart failure, warranting enhanced cardiovascular surveillance during treatment.