| アブストラクト | BACKGROUND: Some novel anticancer agents are associated with drug-induced interstitial lung disease (ILD), a critical and potentially fatal adverse event. Lung cancer patients appear particularly susceptible, yet the risk and clinical characteristics remain incompletely analyzed. OBJECTIVES: To comprehensively evaluate ILD risk and characteristics induced by novel anticancer agents in non-small cell lung cancer (NSCLC) using large-scale real-world data. DESIGN: A retrospective pharmacovigilance study based on spontaneous adverse event reports. METHODS: Data from 2014 to 2024 were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). Reports of NSCLC patients who developed ILD during treatment with FDA-approved novel anticancer agents (immune checkpoint inhibitors, targeted therapies, antibody-drug conjugates). The reporting odds ratio (ROR) was used to assess the disproportionate reporting signals for each drug. Statistical significance was defined when the lower 95% confidence interval (CI) exceeded 1 with at least three reports. RESULTS: A total of 4712 NSCLC cases were analyzed. Eight agents were identified with positive signals for ILD: ROR and 95% CI for nivolumab was 1.28 (1.20-1.38), pembrolizumab 1.47 (1.36-1.59), durvalumab 7.38 (6.90-7.89), atezolizumab 1.25 (1.12-1.39), ipilimumab 1.96 (1.74-2.21), tremelimumab 3.58 (1.97-6.50), trastuzumab-deruxtecan 3.14 (2.29-4.30), osimertinib 1.12 (1.03-1.23). The median onset time was 33 days, with 48.59% of ILD events occurring within the first month. The fatal cases experienced a significantly shorter onset time than non-fatal cases. Older age, male sex, and lower body weight were identified as factors affecting ILD, whereas lower body weight, male sex, and a higher number of concomitant drugs were linked to increased mortality. CONCLUSION: Our study identifies positive signals for ILD with eight novel antineoplastic agents in NSCLC, including nivolumab, pembrolizumab, durvalumab, atezolizumab, ipilimumab, tremelimumab, trastuzumab-deruxtecan, and osimertinib, highlights the importance of monitoring during the first month of therapy, and identifies older male patients with lower body weight as a high-risk group. |
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| 組織名 | Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji;Medical College, Huazhong University of Science and Technology, Wuhan, China.;Medical College, Huazhong University of Science and Technology, Wuhan 430030,;China. |
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