在膀癌患者的外科手术期间使用Enfortumab Vedotin和Pembrolizumab
Christof Vulsteke1,2, Nabil Adra3, Pongwut Danchaivijitr4
1Integrated Cancer Center Ghent, AZ Maria Middelares, Ghent, Belgium.
The New England journal of medicine
|February 18, 2026
概括
术后安福图马布 (vedotin) 加上潘布罗利祖马布 ( pembrolizumab) 显著改善了肌肉侵入性膀癌患者的无事件和整体存活率,这些患者不符合西斯普拉丁化疗的条件. 与单独手术相比,这种联合治疗也增加了病理完整反应率.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 癌症治疗方法 癌症治疗方法
背景情况:
- 肌肉侵入性膀癌 (MIBC) 患者无法接受西斯普拉丁化疗通常会接受激进囊切除术.
- 周围手术治疗提供了一个潜在的策略,以提高这一特定患者群体的结果.
研究的目的:
- 为了评估术后安福图马布 (enfortumab) 韦多加布罗利祖马布 ( pembrolizumab) 结合手术的疗效和安全性,在不接受西斯普拉丁治疗的MIBC患者中.
- 为了比较无事件生存率,总生存率和病理完整反应率与单独的手术.
主要方法:
- 第3期,开放标签,随机试验,涉及不接受西斯的MIBC患者.
- 参与者接受了外科手术前的Enfortumab vedotin加上Pembrolizumab和手术或单独手术.
- 主要终点是无事件生存;次要终点包括整体生存和病理完整反应.
主要成果:
- 经外科手术后的恩福图马布 (enfortumab) 韦多丁加上潘布罗利祖马布 ( pembrolizumab) 显著改善了两年无事件存活率 (74.7% vs 39.4%) 和整体存活率 (79.7% vs 63.1%).
- 综合疗法组的病理完整响应率明显高于组合疗法组 (57.1%对比8.6%).
- 在组合手臂的所有参与者中观察到不良事件,其中71.3%发生了≥3级事件.
结论:
- 术后安福图马布 (vedotin) 加上潘布罗利祖马布 ( pembrolizumab) 提供了显著的生存益处和更高的病理完整响应率,适用于西斯普拉丁不合格的MIBC患者.
- 组合疗法对这一群体来说是一个有前途的治疗方法,尽管安全考虑很重要.
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