非手术治疗不匹配修复缺陷瘤的治疗方法
Andrea Cercek1, Michael B Foote1, Benoit Rousseau1
1Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York.
The New England journal of medicine
|April 28, 2025
概括
新辅助剂编程细胞死亡1 (PD-1) 阻断在早期不匹配修复缺陷 (dMMR) 固体瘤患者中实现了高器官保存率. 这种方法表明了显著的临床完整反应和有利的无复发生存率,提供了非手术治疗的选择.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 新辅助检查点封锁在治疗局部先进的不匹配修复缺陷 (dMMR) 的直肠癌方面表现有前途,消除了许多患者需要手术的需要.
- 这种方法在所有早期dMMR固体瘤中的有效性,无论主要部位如何,仍需确定.
研究的目的:
- 为了评估新辅助剂deliverlimab的有效性,一个编程细胞死亡1 (PD-1) 阻断剂,在早期dMMR固体瘤的患者中.
- 评估dMMR直肠和非直肠固体瘤患者的临床完整反应率和非手术治疗的可行性.
主要方法:
- 进行了一项2期临床试验,涉及患有I,II或III期dMMR固体瘤的患者.
- 患者接受了新辅助剂德拉利马布6个月. 在两个队列中评估了反应:dMMR局部发达的直肠癌 (队列1) 和dMMR非直肠固体瘤 (队列2).
- 达到临床完整反应的患者可以选择非手术治疗;那些残留疾病的患者进行了切除. 主要终点是在队列1的12个月内持续的临床完整响应.
主要成果:
- 在第1组 (直肠癌) 中,所有49名完成治疗的患者都实现了临床完整反应,并选择了非手术治疗,其中37名患者在12个月后表现出持续反应.
- 在第2组 (非直肠瘤) 中,在完成治疗的54名患者中,有35名患者获得了临床完整反应,其中33人进行了非手术治疗.
- 在两个队列中,有103名患者完成了治疗,84人获得了临床完整反应,82人避免了手术. 两年无复发生存率为92%. 副作用主要是可逆的和低度的.
结论:
- 新辅助剂PD-1阻断在早期dMMR固体瘤患者中很大一部分患者的器官保存方面是有效的.
- 该研究支持非手术治疗作为dMMR固体瘤患者的可行选择,这些患者在新辅助PD-1阻断后获得了临床完整反应.
- 安全性概况是有利的,大多数不良事件是轻微的和可逆的.
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