PDF(Pubmed)
Abstract：
Capmatinib is a potent selective mesenchymal-epithelial transition inhibitor approved in 2020 for the treatment of metastatic non-small cell lung cancer. As real-world evidence is very limited, this study evaluated capmatinib-induced adverse events through data mining of the FDA Adverse Event Reporting System database. Four disproportionality analysis methods were employed to quantify the signals of capmatinib-related adverse events. The difference in capmatinib-associated adverse event signals was further investigated with respect to sex, age, weight, dose, onset time, continent, and concomitant drug. A total of 1518 reports and 4278 adverse events induced by capmatinib were identified. New significant adverse event signals emerged, such as dysphagia, dehydration, deafness, vocal cord paralysis, muscle disorder, and oesophageal stenosis. Notably, higher risk of alanine aminotransferase and aspartate aminotransferase increases were observed in females, especially when capmatinib was combined with immune checkpoint inhibitors. Compared with Europeans and Asians, Americans were more likely to experience peripheral swelling, especially in people > 65 years of age. Renal impairment and increased blood creatinine were more likely to occur with single doses above 400 mg and in Asians. This study improves the understanding of safety profile of capmatinib.
摘要：
Capmatinib是一种有效的选择性间充质-上皮转化抑制剂，于2020年被批准用于治疗转移性非小细胞肺癌。由于现实世界的证据非常有限，这项研究通过FDA不良事件报告系统数据库的数据挖掘评估了卡马替尼引起的不良事件.采用四种不成比例分析方法来量化卡马替尼相关不良事件的信号。卡马替尼相关不良事件信号的差异在性别方面进行了进一步研究，年龄,体重,剂量,发病时间,大陆,和伴随的药物。共发现1518例报告和4278例卡马替尼诱导的不良事件。新的重大不良事件信号出现，比如吞咽困难,脱水,耳聋,声带麻痹,肌肉疾病,和食管狭窄.值得注意的是,在女性中观察到丙氨酸氨基转移酶和天冬氨酸氨基转移酶升高的风险更高，尤其是当卡马替尼与免疫检查点抑制剂联用时.与欧洲人和亚洲人相比，美国人更容易出现外周肿胀，尤其是在65岁以上的人群中。单剂量超过400mg和亚洲人更容易发生肾功能损害和血肌酐升高。这项研究提高了对卡马替尼安全性的理解。
