ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Respiratory Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1652750
Risk of interstitial lung disease in non-small cell lung cancer treated with EGFR-TKI: a real-world pharmacovigilance study
Provisionally accepted
- 1Affiliated Hospital of Jiangsu University, Zhenjiang, China
- 2Food and Drug Supervision and Inspection Center in Zhenjiang, Zhenjiang Jiangsu, China
- 3Department of Gastroenterology, Affiliated Hospital of Jiangsu University, Jiangsu University, Zhenjiang, China, Zhenjiang, China
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Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have emerged as a mainstay for patients diagnosed with non-small cell lung cancer (NSCLC). However, interstitial lung disease (ILD), potentially fatal, may develop in certain patients during EGFR-TKI therapy. We aimed to characterize EGFR-TKI-associated ILD and examine the risk factors. Methods: Adverse event (AE) reports from the FDA Adverse Event Reporting System were retrieved from Q1 2004 to Q1 2024. AEs were identified at the preferred term level using the Standardized MedDRA Query. Four disproportionality analyses were conducted to quantify the signal of ILD associated with EGFR-TKIs. The risk of ILD was subsequently analyzed using multifactorial logistic regression. Results: A total of 20,195 EGFR-TKI-related AE reports were analyzed, with 660 cases linked to ILD. osimertinib accounted for the most ILD reports (156), while dacomitinib showed the highest reporting odds. Subgroup analyses revealed distinct pulmonary toxicity profiles across the different EGFR-TKIs. Erlotinib exhibited the longest median time to onset. Older age, concomitant dyslipidemia, and concomitant use of lansoprazole significantly increased the risk. Conclusion: ILD risk is elevated in EGFR-TKI-treated NSCLC patients, particularly with older age, comorbidities, and lansoprazole use. Clinicians should consider these factors to reduce ILD incidence.
Keywords: FDA adverse event reporting system1, EGFR-TKI2, interstitial lung disease3, pharmacovigilance4, adverse events5
Received: 24 Jun 2025; Accepted: 18 Aug 2025.
Copyright: © 2025 Miao, Liu, Li and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Rong Zhao, Department of Gastroenterology, Affiliated Hospital of Jiangsu University, Jiangsu University, Zhenjiang, China, Zhenjiang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.