Tan Yaqian, Song Qi
Department of Pharmacy, The Affiliated Brain Hospital, Guangzhou Medical University, Mingxin Road 36, Liwan District, Guangzhou, 510370, China.
Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, China.
BMC Cancer. 2025 Aug 22;25(1):1360. doi: 10.1186/s12885-025-14743-3.
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.
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.
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 = 5.00, IC = 2.07, PRR = 6.18), myositis (ROR = 2.72, IC = 1.26, PRR = 4.22), and myopathy (ROR = 1.28, IC = 0.63, PRR = 2.32) carried significant risk signals of osimertinib-related myotoxicity.
Our study comprehensively revealed the safety characteristics of osimertinib-associated myotoxicity. The results would offer referable evidence on the safety and prognosis of osimertinib.
奥希替尼是一种第三代表皮生长因子受体酪氨酸激酶抑制剂，已被广泛用作晚期非小细胞肺癌的标准一线治疗药物。然而，奥希替尼相关肌毒性的风险信号尚未得到充分研究。本研究旨在通过进行真实世界的不成比例分析来探索奥希替尼相关的肌毒性。
从美国食品药品监督管理局不良事件报告系统数据库中检索2015年1月1日至2024年3月31日的数据。采用报告比值比（ROR）、比例报告比值（PRR）和信息成分（IC）进行不成比例分析。
共识别并分析了121例奥希替尼相关肌毒性病例。不良事件大多报告于女性（n = 74，61.2%）和65岁以上患者（n = 56，46.3%）。不良事件发病时间的中位数为40（13.3，164.5）。不成比例分析显示，血肌酸磷酸激酶升高（ROR = 5.00，IC = 2.07，PRR = 6.18）、肌炎（ROR = 2.72，IC = 1.26，PRR = 4.22）和肌病（ROR = 1.28，IC = 0.63，PRR = 2.32）具有奥希替尼相关肌毒性的显著风险信号。
我们的研究全面揭示了奥希替尼相关肌毒性的安全性特征。研究结果将为奥希替尼的安全性和预后提供参考依据。
