| アブストラクト | Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment; however, immune-related adverse events (irAEs) in the gastrointestinal (GI) system commonly occur. In this study, data were obtained from the US Food and Drug Administration adverse event reporting system between July 2014 and December 2020. Colitis, hepatobiliary disorders, and pancreatitis were identified as irAEs in our study. Reporting odds ratio (ROR) with information components (IC) was adopted for disproportionate analysis. A total of 70,330 adverse events were reported during the selected period, 4,075 records of which were associated with ICIs. GI toxicities have been reportedly increased with ICI, with ROR025 of 17.2, 6.7, and 2.3 for colitis, hepatobiliary disorders, and pancreatitis, respectively. The risks of colitis, hepatobiliary disorders, and pancreatitis were higher with anti-CTLA-4 treatment than that with anti-PD-1 (ROR025 2.6, 1.3, and 1.1, respectively) or anti-PD-L1 treatment (ROR025 4.8, 1.3, and 1.3, respectively). Logistic analysis indicated that hepatobiliary disorders and pancreatitis more frequently occurred in female patients (adjusted odds ratio, 1.16 and 1.52; both p < 0.05). Consistently, polytherapy was a strong risk factor for colitis (adjusted odds ratio 2.52, p < 0.001), hepatobiliary disorders (adjusted odds ratio 2.50, p < 0.001), and pancreatitis (adjusted odds ratio 2.29, p < 0.001) according to multivariate logistic analysis. This pharmacovigilance analysis demonstrated an increased risk of all three GI irAEs associated with ICI therapies. The comparative analysis offered supportive insights on selecting GI irAEs for patients treated with ICIs. |
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| ジャーナル名 | Frontiers in pharmacology |
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| 投稿日 | 2021/12/17 |
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| 投稿者 | Bai, Xiaoyin; Jiang, Shiyu; Zhou, Yangzhong; Zhen, Hongnan; Ji, Junyi; Li, Yi; Ruan, Gechong; Yang, Yang; Shen, Kaini; Wang, Luo; Li, Guanqiao; Yang, Hong |
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| 組織名 | Department of Gastroenterology, Peking Union Medical College Hospital, Peking;Union Medical College and Chinese Academy of Medical Science, Beijing, China.;Department of Medical Oncology, Shanghai Medical College, Fudan University;Shanghai Cancer Center, Shanghai, China.;Department of Internal Medicine, Peking Union Medical College Hospital, Peking;Department of Radiation Oncology, Peking Union Medical College Hospital, Peking;School of Medicine, Tsinghua University, Beijing, China.;Department of Oncology, Beijing Hospital, National Center of Gerontology,;Beijing, China.;Department of Pharmacy, Peking Union Medical College Hospital, Peking Union;Medical College and Chinese Academy of Medical Science, Beijing, China.;Department of Hematology, Peking Union Medical College Hospital, Peking Union;Department of Respiratory and Critical Care Medicine, Peking Union Medical;College Hospital, Peking Union Medical College and Chinese Academy of Medical;Science, Beijing, China.;Tsinghua Clinical Research Institute, School of Medicine, Tsinghua University, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34912213/ |
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