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在先进的HER2突变非小细胞肺癌中使用一线皮罗替尼:以患者为中心的第二阶段试验

Si-Yang Maggie Liu¹, Hai-Yan Tu², Xue-Wu Wei²

¹Department of Hematology, The First Affiliated Hospital, Jinan University, Guangzhou, China.

Nature medicine

|July 24, 2023

概括

皮罗替尼在 HER2 突变非小细胞肺癌 (NSCLC) 中显示出有希望的疗效. 这种向治疗在第二阶段试验中显示了35.7%的客观反应率,为患有罕见突变的患者提供了新的选择.

科学领域:

在瘤学瘤学.
临床试验临床试验
遗传学遗传学是一个

背景情况:

非小细胞肺癌 (NSCLC) 在针对罕见遗传突变的向治疗中提出了挑战.
以患者为中心的临床试验设计对于探索新型治疗方案至关重要.

研究的目的:

评估pyrotinib在未经治疗的先进的HER2突变NSCLC患者中的疗效和安全性.
为了在现实世界中与医生选择的pyrotinib治疗进行比较.

主要方法:

进行了第二阶段的适应性雨试验,对符合标准的 (CF) 和同情使用 (CU) 队列进行了研究.
一个并行的前性现实世界研究 (RWS) 被启动.
48名患有HER2突变NSCLC的患者接受了pyrotinib (CF/CU) 或医生选择 (RWS) 的治疗.

主要成果:

结核病队列 (n=28) 实现了 35.7% 的客观应答率 (ORR) 与 pyrotinib,中位数无进展生存 (PFS) 的 7.3 个月,和中位数整体生存 (OS) 的 14.3 个月.
CU队列 (n=12) 的ORR为16.7%,PFS的中位数为4.7个月,OS的中位数为14.2个月.
RWS队列 (n=8) 没有反应,中位数PFS为3.0个月,中位数OS为12.2个月.

结论:

在第二阶段试验中,Pyrotinib在HER2突变NSCLC患者中显示出显著的疗效和可接受的安全性.
这项研究强调了针对NSCLC罕见突变的向治疗的潜力.
现实世界的数据表明,需要进一步调查医生为这个人群选择的治疗方法.

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