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在肌肉侵入性膀癌中使用ctDNA引导辅助剂阿特佐利祖马布

Thomas Powles¹, Ariel G Kann², Daniel Castellano³

¹Barts Cancer Institute, National Institute for Health Research Biomedical Research Centre, Queen Mary University of London, London.

The New England journal of medicine

|October 22, 2025

概括

循环瘤DNA (ctDNA) 测试确定了患有肌肉侵入性膀癌的患者,他们受益于atezolizumab. 这种ctDNA引导的免疫疗法显著改善了无病和整体存活率后囊切除术.

科学领域:

在瘤学瘤学.
基因组学就是基因组学.
临床试验临床试验

背景情况:

肌肉侵入性膀癌 (MIBC) 结果在囊切除术后有显著的变化.
循环瘤DNA (ctDNA) 检测分子残留疾病可以识别高风险患者.
由ctDNA指导的辅助免疫疗法可以改善结果并减少治疗负担.

研究的目的:

为了评估ctDNA引导的辅助剂阿特佐利祖马布在MIBC后囊切除术患者的疗效.
评估ctDNA状态对无病生存率 (DFS) 和整体生存率 (OS) 的影响.

主要方法:

第三阶段,双盲,随机试验,使用序列ctDNA测试进行监视.
具有ctDNA阳性的患者被随机分配 (2:1) 接受阿特佐利祖马布或安慰剂,长达1年.
主要终点:由研究人员评估的DFS;次要终点:OS.

主要成果:

与安慰剂相比,阿特佐利祖马布显著改善了中位数的DFS (9.9 vs. 4.8个月) 和OS (32.8 vs. 21.1个月).
复发/死亡和死亡的危险比分分别为0.64和0.59.
持久ctDNA阴性患者的DFS率很高 (95%在1年,88%在2年).

结论:

以ctDNA为导向的辅助治疗与阿特佐利祖马布显著提高了MIBC患者的DFS和OS.
这种方法可以识别可能从免疫疗法中受益的患者,避免其他人不必要的治疗.
该研究为在膀癌管理中以ctDNA为指导的治疗决策提供了一个框架.

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