| アブストラクト | BACKGROUND: The combination regimen with immune checkpoint inhibitors (ICIs) and other therapies has been widely applied for patients with non-small-cell lung cancer (NSCLC). To date, no literature has systematically addressed the risk of hepatitis associated with the combination therapy. We conducted this pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS). PATIENTS AND METHODS: A total of 587,016 NSCLC reports were extracted from FAERS database spanning from the first quarter of 2013 to the second quarter of 2023. After filtering duplicate reports, logistic regression model was used to detect safety signals, and multivariable logistic regression model was used to confirm the interaction between ICI and other drugs. RESULTS: Of the 81,512 patients with NSCLC, 2785 cases developed hepatitis. Multivariable logistic regression analyses revealed that the adjusted ROR of ICI combined with targeted therapy (TT) was the highest 1.64 (95% CI, 1.32-2.02; P < 0.0001) among all therapies, while that of TT and ICI treatment were 1.07 (95% CI, 0.98-1.17; P = 0.1097) and 1.12 (95% CI, 1.03-1.22; P = 0.0111), respectively. The adjusted ROR for the interaction effect was 1.64 (95% CI, 1.32-2.02; P < 0.0001). Furthermore, the adjusted ROR of ICI combined with KRAS-targeted drugs was the highest 3.03 (95% CI, 1.49-5.93; P = 0.0016) among all targeted drugs, with an adjusted ROR of 3.03 (95% CI, 1.49-5.93; P = 0.0016), indicating a meaningful interaction of these two kinds of drugs. CONCLUSION: We confirmed that combination treatment of ICI and TT is associated with the amplified risk of hepatitis, which is partly due to the interaction between ICI and TT, and the KRAS-targeted drugs may harbor the highest potential for hepatitis induction among TT drugs when combined with ICI. Besides, the combination treatment of ICI- and KRAS-targeted drugs also increases the incidence of colitis, pulmonary embolism and dehydration. |
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| ジャーナル名 | Cancer immunology, immunotherapy : CII |
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| Pubmed追加日 | 2024/11/15 |
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| 投稿者 | Li, Zhaohui; Zhou, Zixiang; Zhang, Nan; Tian, Binhe; Chen, Xiangqi; Zhao, Haitao; Wang, Hanping |
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| 組織名 | Department of Thoracic Surgery, Peking Union Medical College Hospital, Chinese;Academy of Medical Sciences & Peking Union Medical College, No. 1 Shuaifuyuan,;Beijing, 100730, China.;Department of Liver Surgery, Peking Union Medical College Hospital, Chinese;Peking Union Medical College, Beijing, China.;Division of Pulmonary and Critical Care Medicine, Peking Union Medical College;Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No.;1 Shuaifuyuan, Beijing, 100730, China.;1 Shuaifuyuan, Beijing, 100730, China. wanghanping78@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39546001/ |
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