| アブストラクト | BACKGROUND: Osimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor that has been widely applied as a standard first-line treatment in advanced non-small cell lung cancer. However, the risk signals of osimertinib-related myotoxicity have not yet been fully examined. This study aimed to explore osimertinib-related myotoxicity by conducting a real-world disproportionality analysis. METHODS: Data from January 1st 2015 to March 31st 2024 were retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database. Reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) were employed to perform disproportionality analysis. RESULTS: A total of 121 cases with osimertinib-related myotoxicity were identified and analyzed. The adverse events were mostly reported in females (n = 74, 61.2%) and patients aged over 65 years old (n = 56, 46.3%). The median value of adverse event onset time was 40 (13.3, 164.5). Disproportionality analysis revealed that blood creatine phosphokinase increased (ROR(025) = 5.00, IC(025) = 2.07, PRR = 6.18), myositis (ROR(025) = 2.72, IC(025) = 1.26, PRR = 4.22), and myopathy (ROR(025) = 1.28, IC(025) = 0.63, PRR = 2.32) carried significant risk signals of osimertinib-related myotoxicity. CONCLUSIONS: Our study comprehensively revealed the safety characteristics of osimertinib-associated myotoxicity. The results would offer referable evidence on the safety and prognosis of osimertinib. |
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| ジャーナル名 | BMC cancer |
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| Pubmed追加日 | 2025/8/26 |
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| 投稿者 | Tan, Yaqian; Song, Qi |
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| 組織名 | Department of Pharmacy, The Affiliated Brain Hospital, Guangzhou Medical;University, Mingxin Road 36, Liwan District, Guangzhou, 510370, China.;tanyaqian2013@163.com.;Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the;Ministry of Education of China, Guangzhou Medical University, Guangzhou, China.;Department of Pharmacy, Guangzhou Institute of Cancer Research, the Affiliated;Cancer Hospital, Guangzhou Medical University, Guangzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40846919/ |
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