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在EGFRm NSCLC患者中Osimertinib的长期耐受性被纳入AURA计划或FLAURA研究中

Marina Chiara Garassino¹, Yong He², Myung-Ju Ahn³

¹Department of Medicine, Hematology Oncology Section, Thoracic Oncology, University of Chicago Medicine & Biological Sciences, Chicago, IL 60637, USA.

Lung cancer (Amsterdam, Netherlands)

|March 8, 2025

概括

长期用osimertinib治疗晚期EGFR突变非小细胞肺癌 (NSCLC) 超过36个月的治疗表明耐受性良好. 这一安全性分析支持在该患者群体中继续使用 osimertinib.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

以表皮生长因子受体 (EGFRm) 突变的高级非小细胞肺癌 (NSCLC) 是一个重大的临床挑战.
奥西默提尼布是EGFRm NSCLC的向治疗,但长期安全数据对于持续治疗决策至关重要.

研究的目的:

在EGFRm晚期NSCLC患者中报告 osimertinib 的长期安全性数据,治疗时间至少为36个月.
分析FLAURA和AURA研究中的安全性和最佳反应数据,用于接受延长性奥西默提尼布治疗的患者.

主要方法:

从注册FLAURA研究和AURA计划 (AURA,AURA2,AURA3) 中获得的安全数据的后期分析.
包括接受一线奥西默提尼布 (FLAURA) 或≥二线奥西默提尼布 (AURA计划) ≥36个月的患者.
分析研究人员报告的严重不良事件 (SAE) 和最佳反应数据,包括研究期间和研究后的事件.

主要成果:

在FLAURA研究中,28%的患者接受了首线奥西默提尼布治疗时间≥36个月 (中位暴露时间为52.5个月).
在AURA计划中,16%的患者接受了≥二线奥西默提尼布≥36个月 (中位暴露44.7个月).
在研究期间,17% (FLAURA) 和35% (AURA计划) 的患者报告了SAE;研究后的SAE分别为11%和21%. 心脏影响和间歇性肺病 (ILD) 是不常见的,并且没有作为研究后的SAE报告.

结论:

长期使用奥西默蒂尼布 (≥36个月) 的治疗在EGFRm高级NSCLC患者中耐受良好.
安全性概况支持在这种患者群体中长时间使用 osimertinib.
大多数患者在长期治疗后获得了部分反应,这是他们研究中最好的反应.

关键词:

长期的长期的长期的在NSCLCLC中,我们可以看到NSCLCLC.奥西默蒂尼布 (Osimertinib) 是一种药物.耐受性耐受性

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