坎雷利祖马布加上化疗与化疗放射治疗作为可切除食道状细胞癌的新辅助疗法:第二阶段随机试验 (REVO)
Peiyuan Wang1,2,3,4, Yujie Chen1, Feng Wang1
1Department of Thoracic Oncology Surgery, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
新辅助剂卡姆雷利祖马布加化疗 (ICT) 对食道状细胞癌 (ESCC) 的疗效与化疗放射疗法 (CRT) 不相差. ICT显示出更有利的安全性,使其成为可切除ESCC的可行治疗选择.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 胃肠道癌症 胃肠道癌症
背景情况:
- 对于新辅助性PD-1抑制剂加上化疗与化学辐射疗法 (CRT) 在局部发达的食道状细胞癌 (ESCC) 中存在有限的比较数据.
- 新辅助治疗旨在改善局部发达ESCC的切除能力和结果.
研究的目的:
- 在可切除,局部晚期ESCC的患者中,与CRT相比,评估新辅助性camrelizumab加化疗 (ICT) 的非劣势性.
- 评估两种新辅助治疗策略的疗效和安全性.
主要方法:
- 一个多中心的,随机的,开放的,第二阶段的非劣势性试验 (REVO,NCT05007145) 涉及104名可切除,局部发达ESCC的患者.
- 患者被随机分配到接受ICT (卡梅利祖马布,纳布-帕克利塔塞尔,西斯普拉丁) 或CRT (纳布-帕克利塔塞尔,西斯普拉丁,放射治疗).
- 主要终点是病理完整反应 (pCR).
主要成果:
- 与CRT (34.6%) 相比,ICT的pCR率 (32.7%) 并没有低于CRT (34.6%).
- 主要病理反应率为ICT的42.3%和CRT的57.7%;R0切除在两只手臂中都是100%.
- 信息通信技术显示出更有利的安全概况,与治疗相关的3级以上不良事件率较低 (19.2%与33.3%) 和类似的手术并发症率.
- 一年无病生存率 (89.1%vs. 78.2%) 和整体生存率 (100%vs. 92.3%) 受益于ICT.
结论:
- 新辅助ICT是一种安全有效的CRT替代方案,用于切除局部先进ESCC.
- 信息通信技术提供了更有利的安全概况,支持其在临床实践中的使用.
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