通过基于免疫疗法的全新辅助疗法在早期低直肠癌 (TORCH-E) 中保存器官:一个多中心,开放标签,单臂,II期研究
Fan Xia1,2,3,4, Yajie Chen1,2,3,4, Di Zhou5
1Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
概括
基于免疫疗法的全新辅助疗法 (iTNT) 显示了早期低直肠癌中器官保存的希望. 这种方法实现了高的完全反应率,使许多患者能够进行非手术治疗.
科学领域:
- 在瘤学瘤学.
- 手术瘤学手术瘤学
- 胃肠病学 胃肠病学
背景情况:
- 器官保存 (OP) 在低直肠癌中至关重要,以最大限度地降低手术致病率.
- 基于免疫治疗的全新辅助疗法 (iTNT) 已显示出显著的瘤回归,并促进了晚期直肠癌的OP.
研究的目的:
- 评估iTNT的有效性和安全性,以使早期低直肠癌的器官保存.
- 该iTNT疗程包括短期放射治疗,随后是CAPOX和toripalimab.
主要方法:
- 一个多中心,单臂II期试验 (TORCH-E) 招募了T2-3bN0直肠腺癌患者.
- 患者接受了短期放射治疗 (25 Gy/5 Fx),随后接受了CAPOX加toripalimab.
- 良好的响应者是观察和等待 (WW) 或局部切除 (LE) 的候选人;响应不良的患者接受了全腹腔切除.
主要成果:
- 招募了33名患者;16名患者实现了临床完整反应 (CR),并选择了WW.
- 病理性CR在8/8LE和5/9的患者中被观察到,这些患者经过了全腹膜切除.
- 总体CR率为72.7%,OP率为60.6%,血栓细胞减小是最常见的3-4级不良事件 (27.3%).
结论:
- 该TORCH-E试验表明,iTNT是一种有前途的方法,可以在早期低直肠癌中实现高CR率.
- 这一策略通过观察和等待和选择性局部切除来促进器官的保存.
- 需要进一步的随机试验来验证这些发现.
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