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在晚期肝细胞癌中免疫治疗的替代和修改的终点

Mir Lim¹, Maishara Muquith¹, Bernadette Miramontes¹

¹Division of Hematology and Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Hepatology (Baltimore, Md.)

|May 31, 2023

概括

对于用免疫疗法治疗的肝细胞癌 (HCC),RECIST标准预测了整体存活率 (OS). 修改后的RECIST (mRECIST) 和免疫修改后的RECIST (imRECIST) 没有改善OS预测,尽管它们的目的是用于早期评估.

科学领域:

肝细胞癌研究肝细胞癌研究
免疫治疗的有效性免疫治疗的有效性
临床试验终点临床试验终点

背景情况:

免疫疗法已经改变了肝细胞癌 (HCC) 治疗方法.
替代和修改的终点对于评估早期治疗成功和指导临床实践至关重要.
修改瘤反应标准在预测免疫疗法治疗HCC的整体存活期 (OS) 中的有效性需要研究.

研究的目的:

评估代用终点,特别是RECIST (固体瘤响应评估标准),修改后的RECIST (mRECIST) 和免疫修改后的RECIST (imRECIST) 是否准确地预测接受免疫治疗的HCC患者的OS.
为了比较RECIST,mRECIST和imRECIST在接受免疫治疗的HCC患者中对OS的预测能力.

主要方法:

对IMbrave150试验 (阿特佐利祖马布和贝瓦齐祖马布,N=279) 进行了个体级别的后期分析.
进行了免疫疗法治疗的多中心现实世界队列 (N=328) 的横截面分析.
使用里程碑式分析来评估客观响应率 (ORR) 与不同标准和OS之间的关联.

主要成果:

RECIST的客观应答率与HCC患者的生存状况改善有关,包括患有Child-Pugh A和B的患者,以及在一线或二线设置中 (IMbrave150:HR 0.24;RW:HR 0.25).
与RECIST相比,mRECIST和imRECIST的客观响应率没有显示出更大的操作系统益处预测能力 (mRECIST:HR 0.30;imRECIST:HR 0.36).
使用RECIST的无进展存活率 (PFS) 与OS中度相关,使用mRECIST或imRECIST没有观察到改善.

结论:

RECIST客观反应率是评估新兴HCC免疫疗法的有效信号查找措施.
与预期相反,mRECIST和imRECIST在用免疫疗法治疗的HCC患者的OS益处预测方面没有显著改善.
这些发现澄清了在HCC免疫治疗中不同终点的有用性.

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