| アブストラクト | BACKGROUND: Epidermal Growth Factor Receptor/ Anaplastic Lymphoma Kinase Tyrosine kinase inhibitors (EGFR/ALK TKIs) may provoke fatal interstitial pneumonitis (IP). The study was conducted to characterize the main characteristics of EGFR/ALK TKI-induced IP and identify factors associated with death. RESEARCH DESIGN AND METHODS: A disproportionality analysis was conducted using Vigibase, the World Health Organization pharmacovigilance database. Clinical features of patients with EGFR/ALK-TKI-related IP were compared between the fatal and non-fatal groups. RESULTS: A total of 3355 EGFR/ALK-TKI-IP events were identified, over half of them from Asia (57.47%) and mostly the aged (63.21%). Osimertinib appeared the strongest IP association. The median time to onset (TTO) was 40 (interquartile range [IQR] 16-84) days. There were significant differences between the fatal and non-fatal groups in terms of reporting year and TKI regimens (P < 0.05). The fatality rate of erlotinib-induced IP was the highest (35.54%). CONCLUSION: Our study showed that EGFR/ALK TKIs were associated with IP that had a high fatality rate and tended to occur earlier in fatal cases. It is necessary to raise awareness of IP surveillance when EGFR/ALK TKIs were administered. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2022/8/5 |
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| 投稿者 | Ma, Zhuo; Pei, Jie; Zhang, Yi; Li, Hao; Sun, Dan; Zhang, Yuhui; An, Zhuoling |
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| 組織名 | Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University,;Beijing, China.;Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital,;Capital Medical University, Beijing Institute of Respiratory Medicine, Beijing,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35924402/ |
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