新辅助剂和辅助剂奥西默提尼布在IA至IIIA阶段,EGFR突变NSCLC (NORA)
Jii Bum Lee1, Su-Jin Choi1, Hyo Sup Shim2
1Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
概括
新辅助剂奥西默提尼布在可切除EGFR突变非小细胞肺癌 (NSCLC) 中显示出可行性和可管理的安全性. 然而,它没有满足客观响应率 (ORR) 的初级终点.
科学领域:
- 在瘤学瘤学.
- 胸部外科手术 胸部外科手术
- 药理学 药理学 是一个学科.
背景情况:
- 辅助性奥西默蒂尼布是切除EGFR突变性NSCLC的标准.
- 新辅助剂奥西默蒂尼布的作用正在调查中.
研究的目的:
- 评估新辅助性奥西默蒂尼布在可切除EGFR突变NSCLC中的疗效和安全性.
- 评估经过两次新辅助性 osimertinib 的客观反应率 (ORR).
主要方法:
- 在25名可切除EGFR突变NSCLC患者的试点研究中.
- 用两轮新辅助性奥西默蒂尼布治疗,然后进行手术和辅助性奥西默蒂尼布治疗.
- 主要的终点:ORR. 二级终点:病理反应率,循环瘤DNA (ctDNA) 清除.
主要成果:
- ORR为44% (所有部分响应);56%的病情稳定.
- 主要病理反应率为24%,病理完整反应率为0%.
- 在一周期后,在30%的基线阳性患者中观察到ctDNA清除;没有3级不良事件.
结论:
- 新辅助剂奥西默蒂尼布没有满足ORR的主要终点.
- 这种方法在这种患者群体中具有可管理的安全概况时是可行的.
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