研究动态
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早期CRP动力学预测NSCLC中免疫治疗的OAK三期试验反应。

Early CRP kinetics predicts immunotherapy response in NSCLC in the phase III OAK trial.

发表日期:2023 Apr 02
作者: Jonas Saal, Tobias Bald, Markus Eckstein, Manuel Ritter, Peter Brossart, Jörg Ellinger, Michael Hölzel, Niklas Klümper
来源: Experimental Hematology & Oncology

摘要:

静态生物标记物如PD-L1不足以准确预测免疫检查点抑制(ICI)的治疗反应。因此,目前正将测量即时治疗相关变化的治疗期生物标记物放在免疫肿瘤学的重点方向。一个简单预测的治疗期生物标记物的主要例子是早期C-反应蛋白(CRP)动力学及其预测的CRP爆发反应现象。本文中,我们能够在关键的3期OAK试验(NCT02008227)中证实了早期CRP动力学的预测价值,该试验比较了非小细胞肺癌(NSCLC)患者中使用阿特伊珠单抗和多西他赛的情况。需要注意的是,CRP爆发反应仅预测了接受ICI治疗亚组的有利结局,这表明这是一种免疫治疗特异性现象。总之,我们首次在一项关键的3期试验中验证了早期CRP动力学的高预测价值,证明这种费用低廉且易于实施的治疗期生物标志物的广泛使用可优化NSCLC患者的治疗监测。©作者(们)2023。由牛津大学出版社出版。
Static biomarkers like PD-L1 are insufficient to accurately predict response to immune checkpoint inhibition (ICI). Therefore, on-treatment biomarkers, that measure immediate therapy-associated changes, are currently shifting into the focus of immuno-oncology. A prime example of a simple predictive on-treatment biomarker is the early C-reactive protein (CRP) kinetics with its predictive CRP flare-response phenomenon. Here, we were able to confirm the predictive value of CRP-flare response kinetics in the pivotal phase 3 OAK trial (NCT02008227), which compared atezolizumab with docetaxel in patients with non-small cell lung cancer (NSCLC). Of note, CRP flare-response predicted favorable outcomes only in the ICI-treated subgroup, which suggests that it is an immunotherapy-specific phenomenon. In conclusion, we have for the first time validated the high predictive value of early CRP kinetics in a pivotal phase 3 trial, justifying the broad use of this cost-effective and easy-to-implement on-treatment biomarker to optimize therapy monitoring for patients with NSCLC.© The Author(s) 2023. Published by Oxford University Press.