Vol. 3 No. 2 (2026)

Research Articles

Safety Evaluation of EGFR-TKI Therapy in Patients with Non-Small Cell Lung Cancer: A Real-World Study Based on theFAERS Database

Published 2026-03-31

  • Xiongzhou Zhang
    • ,
  • Shujie Liu
    • ,
  • Baojia Qi
    • ,
  • Bin Li
    • ,
  • Chaojun Duan

Xiongzhou Zhang
Xiangya Hospital Central South University image/svg+xml , Hunan Engineering Research Center for Pulmonary Nodules Precise Diagnosis & Treatment

Shujie Liu
Xiangya Hospital Central South University image/svg+xml

Baojia Qi
Postgraduate Training Base Alliance of Wenzhou Medical University (Zhejiang Cancer Hospital)

Bin Li
Xiangya Hospital Central South University image/svg+xml

Chaojun Duan
Xiangya Hospital Central South University image/svg+xml , Hunan Engineering Research Center for Pulmonary Nodules Precise Diagnosis & Treatment , National Clinical Research Center for Geriatric Disease (Xiangya Hospital)

Abstract

Background: Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) have been widely employed in the treatment of non-small cell lung cancer (NSCLC) patients harboring EGFR mutations. However, systematic compara-tive studies assessing the adverse events (AEs) associated with various EGFR-TKI agents remain relatively scarce. 

Method: This study conducted a real-world analysis of the safety proile of EGFR-TKI treatment in NSCLC patients, utilizing data from the FDA Adverse Event Report-ing System (FAERS) database. A total of 22,160 AE reports pertaining to afatinib, osimertinib, erlotinib, and geitinib were included. The safety proiles were evalu-ated through disproportionality analysis (including ROR and PRR) alongside de-scriptive statistics. 

Results: This study analyzed 22,160 reports of adverse events (AEs) associated with EGFR-TKIs. The incidence of AEs was signiicantly higher for Osimertinib (7,142 cases) and Erlotinib (7,886 cases), compared to Afatinib (3,287 cases) and Geitinib (3,845 cases). Females constituted 58.3% of the cohort; notably, Osimer-tinib exhibited the highest proportion of patients over 85 years old (3.2%). Dispro-portionality analysis revealed speciic drug-related risks: Afatinib was particularly associated with Paronychia (PRR=13.89, ROR=14.12), Osimertinib with Acquired gene mutations (PRR=20.18, ROR=20.44), Erlotinib with Dermatitis acneiform (PRR=5.47, ROR=5.50), and Geitinib also with Acquired gene mutations (PRR=11.62, ROR=11.74). Cross-drug surveillance should prioritize common risks such as Malignant neoplasm progression and Interstitial lung disease.

Conclusion: There are signiicant discrepancies in the safety proiles among differ-ent EGFR-TKIs. In clinical practice, it is crucial to closely monitor the high-incidence AEs associated with speciic drugs in order to facilitate individualized treatment while minimizing potential risks.

Keywords

Adverse Event, EGFR-TKIs, NSCLC, FAERS

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