| アブストラクト | OBJECTIVES: There has been a yearly increase in the incidence of interstitial lung disease (ILD) adverse events associated with antibody-drug conjugates (ADCs), which is becoming a significant challenge for the clinical application of ADCs. We aim to conduct an exhaustive analysis of the clinical characteristics and outcomes of ADC-associated ILD in the real world. METHODS: We utilized the FDA Adverse Event Reporting System database spanning from January 2004 to September 2023 to evaluate the clinical characteristics, onset times, and outcomes of ADC-associated ILD adverse events in patients. Additionally, safety signals were generated using disproportionality and Bayesian analyses to evaluate the association between ADC and ILD. RESULTS: Out of the fifteen ADCs, ten were recorded to have caused ILD adverse events, accounting for a total of 643 reported cases. Eight ADCs exhibited statistically significant safety signals related to ILD in both disproportionality and Bayesian analyses. Trastuzumab deruxtecan recorded the highest reporting odds ratio (ROR) = 49.04 [95% confidence interval (CI) =44.41-54.17], proportional reporting ratio (PRR) = 43.90 (chi2 = 18 297.87), empirical Bayes geometric mean = 43.45 (95% one-sided CI, 39.98). 44.20% of adverse reactions were recognized within the first month of ADC treatment. The median time to onset for ILD related to gemtuzumab ozogamicin was notably the shortest at 4 days [interquartile range (IQR): 2-12 days], and it had the highest fatality proportion, standing at 57.14%. CONCLUSIONS: This study analyzed demographic, temporal and outcome profiles of ADC-related ILD cases and identified high-risk signals. These findings help raise awareness and improve the monitoring of adverse events related to ADC. In the future, large-scale prospective studies are needed to further confirm and explore the underlying biological mechanisms. |
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| ジャーナル名 | The oncologist |
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| Pubmed追加日 | 2025/9/1 |
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| 投稿者 | Fang, Nan; Wang, Xiang; Xu, Zhiqing; Zhan, Hongyan; Wang, Yuqing; Zhao, Bin; Huang, Hui; Lin, Mingbao |
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| 組織名 | Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of;Medical Science and Peking Union Medical College, Beijing 100730, China.;Department of Pharmacy, Capital Medical University School of Stomatology, Beijing;100050, China.;Department of Medical Oncology, Peking Union Medical College Hospital, Chinese;Academy of Medical Science and Peking Union Medical College, Beijing 100730,;China.;State Key Laboratory of Bioactive Substances and Functions of Natural Medicines,;Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union;Medical College, Beijing 100050, China.;Department of Pulmonary and Critical Care Medicine, Peking Union Medical College;Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,;Beijing 100730, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40888754/ |
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