Omoto Takashi, Asaka Junichi, Kudo Kenzo
Department of Pharmacy, Iwate Medical University Hospital, Shiwa, Japan.
Division of Clinical Pharmaceutics and Pharmacy Practice, Department of Clinical Pharmacy, School of Pharmacy, Iwate Medical University, Shiwa, Japan.
Cancer Diagn Progn. 2024 Sep 1;4(5):631-637. doi: 10.21873/cdp.10374. eCollection 2024 Sep-Oct.
BACKGROUND/AIM: Osimertinib is a well-tolerated first- or second-line treatment option for elderly patients with epidermal growth factor receptor mutation-positive advanced non-small cell lung cancer. However, the safety of osimertinib in elderly patients requires further investigation. Herein, we identified safety signals for various osimertinib-related adverse events (AEs) in elderly patients by disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database.
Data from the JADER database from April 2004 to March 2023 were obtained from the Pharmaceuticals and Medical Devices Agency website. Safety signal detection for osimertinib-related AEs in elderly patients (≥70 years old) was determined using the relative elderly reporting odds ratio (ROR). For osimertinib-related AEs, we extracted 92 preferred terms (PTs) and nine standardized MedDRA queries (SMQs).
Safety signals in elderly patients were detected for "Cardiomyopathy (PT)" and "Cardiomyopathy (SMQ)". The symptoms most frequently associated with "Cardiomyopathy (SMQ)" included "Ejection fraction decreased (PT)", "Cardiomyopathy (PT)", and "Stress cardiomyopathy (PT)". Notably, 53.7% of these outcomes were "Recovery" or "Remission". The median time to the onset of "Cardiomyopathy (SMQ)" in elderly patients was 85 days (range=2-537 days).
We demonstrated that patients ≥70 years potentially have increased osimertinib-related cardiomyopathy compared with patients <70 years. In the future, it is necessary to conduct research focusing on cardiomyopathy in elderly patients.
背景/目的：奥希替尼是表皮生长因子受体突变阳性的老年晚期非小细胞肺癌患者耐受性良好的一线或二线治疗选择。然而，奥希替尼在老年患者中的安全性需要进一步研究。在此，我们通过使用日本药品不良事件报告（JADER）数据库进行比例失衡分析，确定了老年患者中各种奥希替尼相关不良事件（AE）的安全信号。
从药品和医疗器械管理局网站获取2004年4月至2023年3月JADER数据库的数据。使用相对老年报告比值比（ROR）确定老年患者（≥70岁）中奥希替尼相关AE的安全信号检测。对于奥希替尼相关AE，我们提取了92个首选术语（PT）和9个标准化医学术语集查询（SMQ）。
在老年患者中检测到“心肌病（PT）”和“心肌病（SMQ）”的安全信号。与“心肌病（SMQ）”最常相关的症状包括“射血分数降低（PT）”、“心肌病（PT）”和“应激性心肌病（PT）”。值得注意的是，这些结果中有53.7%为“恢复”或“缓解”。老年患者中“心肌病（SMQ）”发作的中位时间为85天（范围=2-537天）。
我们证明，与<70岁的患者相比，≥70岁的患者发生奥希替尼相关心肌病的可能性可能增加。未来，有必要开展针对老年患者心肌病的研究。
