新辅助化学辐射疗法加上编程细胞死亡蛋白-1阻塞与肌肉侵入性膀癌单独化学辐射疗法:现实世界的比较研究
Fan Zhang1,2, Jingsuo Wang1, Yanhang Yu1
1Department of Urology, First Affiliated Hospital of Soochow University, Suzhou, China.
Frontiers in immunology
|December 15, 2025
概括
将PD-1阻断添加到新辅助化学放射治疗 (NACRT) 中,显著改善了肌肉侵入性膀癌 (MIBC) 患者的病理完整反应率,而不会增加毒性. 需要进一步的试验来证实生存效益.
科学领域:
- 在瘤学瘤学.
- 尿癌研究 尿癌研究
- 癌症治疗策略 癌症治疗策略
背景情况:
- 肌肉侵入性膀癌 (MIBC) 携带高复发风险和细胞切除术后的死亡率.
- 新辅助化学放射疗法 (NACRT) 正在探索膀保护,但其与PD-1抑制剂在激进囊切除术环境中的组合正在调查中.
- PD-1 抑制剂在尿路癌中表现出抗瘤活性,这表明与 NACRT 的潜在协同作用.
研究的目的:
- 为了在MIBC患者中比较单独使用NACRT与与PD-1阻断 (NACRT+PD-1) 结合使用NACRT的病理反应和短期安全性.
- 评估PD-1抑制剂 (托利帕利马布,蒂塞利祖马布) 在激进囊切除术前增强瘤反应的疗效.
主要方法:
- 在2021年1月至2024年12月期间接受治疗的59名MIBC患者 (cT2-T4aN0M0) 的回顾性分析.
- 患者接受单独的NACRT (n=27) 或NACRT+PD-1抑制剂 (n=32).
- 标准化疗 (gemcitabine/cisplatin),强度调节的盆腔放射疗法和PD-1抗体输注进行了治疗;主要终点是病理下降阶段和完全响应率.
主要成果:
- 病理完整响应率 (PCRR) 从单独使用NACRT的44.44%显著增加到NACRT + PD-1 (p=0.033) 的71.88%.
- 与单独使用NACRT (74.07%) 相比,NACRT+PD-1组的病态衰退率在数值上更高 (87.50%),尽管在统计学上并不显著 (p=0.187).
- 没有发生≥4级不良事件或与治疗相关的死亡;EA频率在各组之间相似,表明可比的短期安全性.
结论:
- 将NACRT与PD-1阻断相结合,可显著提高MIBC患者进行激进囊切除术的病理完整响应率.
- 这种组合治疗表明可以接受的短期安全性,与单独使用NACRT相比,严重不良事件没有增加.
- 这些发现支持在前性试验中进一步调查,以确认NACRT + PD-1阻断对长期生存的潜在益处.
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