A retrospective study of ensartinib-treated ALK-positive locally advanced or metastatic NSCLC patients in China

Pub Date : 2023-11-07 DOI:10.2217/lmt-2023-0005
Xiaobin Yuan, Yang Wang, Min Yang, Pengxiang Wu, Hui Chen, Yu Yun, Zhilin Shen, Dong Ji, Yongbin Ma, Lieming Ding
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Abstract

Aim: This retrospective study aimed to assess the efficacy and safety of ensartinib in Chinese patients with ALK-positive advanced NSCLC in real-world clinical practice. Methods: Clinical data from ALK-positive NSCLC patients treated with ensartinib in China were collected and analyzed. Efficacy end points included objective response rate and progression-free survival. Safety profiles were also evaluated. Results: A total of 682 patients were included in this study. The study demonstrated promising efficacy with an objective response rate of 54.0%, and the median progression-free survival was not estimable. Ensartinib exhibited a manageable safety profile with treatment-related adverse events (TRAEs) consistent with prior clinical trials. The most common TRAE was rash (21.1%) and no TRAE led to death. Conclusion: Ensartinib is active and well tolerated for ALK-positive NSCLC patients in real-world clinical settings.
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恩沙替尼治疗中国alk阳性局部晚期或转移性NSCLC患者的回顾性研究
目的:本回顾性研究旨在评估恩沙替尼在中国alk阳性晚期NSCLC患者临床实践中的有效性和安全性。方法:收集并分析国内接受恩沙替尼治疗的alk阳性NSCLC患者的临床资料。疗效终点包括客观缓解率和无进展生存期。安全性也进行了评估。结果:本研究共纳入682例患者。该研究显示有希望的疗效,客观缓解率为54.0%,中位无进展生存期无法估计。恩沙替尼显示出可控的安全性,治疗相关不良事件(TRAEs)与先前的临床试验一致。最常见的TRAE是皮疹(21.1%),没有TRAE导致死亡。结论:在现实世界的临床环境中,恩沙替尼对alk阳性NSCLC患者具有活性和良好的耐受性。
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