University of Nevada, Reno School of Medicine, Department of Internal Medicine, United States.
University of Southern California, Keck School of Medicine, Department of Radiology, United States.
Cancer Treat Res Commun. 2020;25:100254. doi: 10.1016/j.ctarc.2020.100254. Epub 2020 Nov 29.
Lung cancer is the second most common cancer in both men and women and the leading cause of cancer death worldwide. The development of novel tyrosine kinase inhibitors (TKIs) represented a paradigm shift in the management of lung cancer and has resulted in markedly prolonged survival. Osimertinib is a TKI that was fast-tracked by the United States Food and Drug Administration in 2015 and subsequently approved for the treatment of metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. However, despite the generally favorable outcomes associated with osimertinib, rapid development and deployment of any new drug increases the risk of unforeseen adverse effects. Post-marketing surveillance studies therefore play an important role in further elucidating the risks and benefits of novel anti-neoplastic agents.
We describe four patients with non-small cell lung cancer who developed myositis after beginning treatment with osimertinib. In addition, we review the literature on osimertinib-associated myositis. Using PubMed, the following terms were searched and relevant citations assessed: creatine phosphokinase, myositis, osimertinib, rhabdomyolysis, osimertinib, and Tagrisso.
Thirty-eight patients were treated with osimertinib in our community clinic. Four with non-small cell lung cancer developed myositis after beginning treatment. The onset of symptoms and/or elevation of creatine phosphokinase occurred between two weeks and eleven months after osimertinib was initiated. Alternative causes for myositis were not identified. In two patients, myositis resolved within one month of withdrawing treatment. Two other patients continued osimertinib treatment with close monitoring.
Myositis is a serious and potentially underreported adverse effect of osimertinib. Previous studies suggest that osimertinib-associated myositis is rare, occurring in less than 1% of patients. However, myositis occurred in over 10% of patients treated with osimertinib in our clinic population. We suggest regular monitoring for myositis among patients being treated with osimertinib and dose-reduction or cessation of treatment if clinically indicated.
肺癌是男性和女性中第二常见的癌症，也是全球癌症死亡的主要原因。新型酪氨酸激酶抑制剂（TKI）的开发代表了肺癌治疗的范式转变，导致生存时间显著延长。奥希替尼是一种 TKI，于 2015 年被美国食品和药物管理局快速审批，并随后批准用于治疗转移性表皮生长因子受体 T790M 突变阳性非小细胞肺癌。然而，尽管奥希替尼通常具有良好的疗效，但任何新药的快速开发和应用都会增加出现不可预见的不良反应的风险。因此，上市后监测研究在进一步阐明新型抗肿瘤药物的风险和益处方面发挥着重要作用。
我们描述了 4 例开始奥希替尼治疗后发生肌炎的非小细胞肺癌患者。此外，我们还回顾了奥希替尼相关肌炎的文献。使用 PubMed，搜索了以下术语，并评估了相关文献：肌酸磷酸激酶、肌炎、奥希替尼、横纹肌溶解症、奥希替尼、Tagrisso。
在我们的社区诊所，有 38 例患者接受了奥希替尼治疗。其中 4 例非小细胞肺癌患者在开始治疗后发生肌炎。症状和/或肌酸磷酸激酶升高发生在奥希替尼开始后 2 周至 11 个月。未发现肌炎的其他病因。在 2 例患者中，停用治疗后 1 个月内肌炎得到缓解。另外 2 例患者继续密切监测奥希替尼治疗。
肌炎是奥希替尼的一种严重且潜在漏报的不良反应。先前的研究表明，奥希替尼相关肌炎罕见，不到 1%的患者发生。然而，在我们的诊所人群中，接受奥希替尼治疗的患者中有超过 10%发生了肌炎。我们建议在接受奥希替尼治疗的患者中定期监测肌炎，并在临床需要时减少剂量或停止治疗。
