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本梅尔斯托巴特,安洛提尼布和化疗在广泛阶段的小细胞肺癌:一个随机的第三阶段试验

Ying Cheng¹, Jianhua Chen², Wei Zhang³

¹Jilin Cancer Hospital, Changchun, China. jl.cheng@163.com.

Nature medicine

|July 11, 2024

概括

将抗血管生成疗法添加到标准化疗中,显著改善了扩散阶段小细胞肺癌患者的整体存活率. 这种组合疗法显示了可容忍的安全性,提供了一个有前途的新治疗方案.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药理学药理学是指药理学的学科.

背景情况:

免疫化疗是扩散阶段小细胞肺癌 (ES-SCLC) 的标准第一线治疗方法.
将免疫疗法与抗血管生成药物结合使用可能会提高ES-SCLC的治疗疗效.

研究的目的:

为了研究本梅尔斯托巴特 (PD-L1抑制剂) 加上安洛丁尼布 (抗血管生成) 与化疗在未经治疗的ES-SCLC患者的疗效和安全性.
报告ETER701第3期试验的最终无进展生存率和临时总生存率 (OS) 分析.

主要方法:

一个多中心,双盲,随机,安慰剂控制的第三期试验 (ETER701).
患者接受了本梅尔斯托巴特+安洛提尼布+埃托化物/卡博普拉丁 (EC),安慰剂+安洛提尼布+EC,或单独接受EC.
主要终点:无进展生存率 (PFS) 和总生存率 (OS).

主要成果:

在使用本梅尔斯托巴特+安洛提尼布+EC与单独使用EC时,中位 OS 显著延长 (19.3 vs 11.9 个月;HR 0.61;P=0.0002).
与单独使用EC相比,安洛丁尼布+EC没有显示出统计学上显著的OS改善 (13.3 vs 11.9个月;HR 0.86;P=0.1723).
在所有手臂中都观察到高水平的3级+治疗相关不良事件.

结论:

在标准化疗中添加本梅尔斯托巴特和安洛提尼布,在ES-SCLC中显著改善了OS.
这种组合表明了可容忍和可管理的安全性.
与免疫化疗相结合的抗血管生成疗法可能是ES-SCLC管理的有效和安全策略.

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