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针对晚期或复发性子宫内膜癌 (AtTEnd) 的阿特佐利祖马布和化疗:一个随机,双盲,安慰剂控制的第三期试验

Nicoletta Colombo¹, Elena Biagioli², Kenichi Harano³

¹European Institute of Oncology IRCCS, Milan, Italy; University of Milan-Bicocca, Milan, Italy.

The Lancet. Oncology

|August 5, 2024

概括

在晚期或复发性子宫内膜癌患者中,添加阿特佐利祖马布 (atezolizumab) 于化疗改善了无进展生存率,特别是那些有不匹配修复缺陷 (dMMR) 瘤的患者. 这种组合显示出作为这一子组的第一线治疗的希望.

科学领域:

在瘤学瘤学.
临床试验临床试验
免疫治疗是一种免疫疗法.

背景情况:

晚期或复发的子宫内膜癌的标准治疗历史上涉及卡博普拉丁和帕克利塔塞尔化疗.
在AtTEnd试验中,研究了添加阿特佐利祖马布 (atezolizumab) 于这种标准化疗方案的疗效.

研究的目的:

评估是否将阿特佐利祖马布与化疗结合起来可以改善晚期或复发性子宫内膜癌患者的治疗结果.
评估在总人口中和患有不匹配修复缺陷 (dMMR) 瘤的患者中无进展生存 (PFS) 和整体生存 (OS).

主要方法:

一个多中心的,双盲的,随机的,安慰剂控制的,第三阶段试验 (AtTEnd) 涉及551名患者.
患者在6-8个周期内静脉注射阿特佐利祖马布或安慰剂,加上卡博普拉丁和帕克利塔克塞尔化疗.
主要终点是dMMR和整体人口中的PFS,以及整体人口中的OS.

主要成果:

阿特佐利祖马布在dMMR群体 (HR 0.36) 和整体群体 (HR 0.74) 中显著增加了PFS.
在dMMR患者中,阿特佐利祖马布组的PFS中位数无法估计,而安慰剂组的PFS中位数为6.9个月.
中位 OS 显示了阿特佐利祖马布 (38.7 个月 vs 30.2 个月) 的改善趋势.
最常见的3-4级不良事件包括中性衰竭和贫血;严重的不良事件在阿特佐利祖马布组中较高.

结论:

在先进或复发性子宫内膜癌中,Atezolizumab加化学疗法显示增加了无进展的存活率.
对于患有dMMR子宫内膜癌的患者来说,添加阿特佐利祖马布特别有益.
这种组合表明,对于这个特定的患者亚组来说,它有可能成为一线治疗.

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