在局部晚期子宫癌中,尼沃卢马布加化学放射治疗:NICOL第一阶段试验
Manuel Rodrigues1, Giulia Vanoni2, Pierre Loap3
1Department of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France.
与PD-1阻断同时进行化学放射治疗对于宫癌是安全的,显示93.8%的应答率和75%的2年无进展生存率. 免疫标志物预测患者的结果,表明有针对性的治疗的潜力.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 与PD-1通路阻塞相结合的同时进行化学放射治疗 (CRT) 可能会改善抗瘤免疫力.
- 尼沃卢马布是一种免疫检查点抑制剂,向PD-1通路.
研究的目的:
- 评估nivolumab与局部晚期宫癌的同时CRT的安全性和耐受性.
- 为了确定尼沃卢马布推的II期剂量.
- 为了评估免疫反应的相关性.
主要方法:
- 第1期临床试验 (NiCOL) 招募了16名患有局部晚期宫癌的妇女.
- 尼沃卢马布与最终的CRT并发,或在CRT后同时使用.
- 安全性评估,客观反应率 (ORR),无进展生存率 (PFS) 和免疫生物标志物.
主要成果:
- 组合疗法达到预先规定的终点,显示出93.8%的ORR和75%的2年PFS.
- 三名患者出现了剂量限制性毒性 (3级).
- 没有进展的患者表现出明显的免疫特征,包括增加膜透和T细胞接近瘤细胞.
结论:
- 同时使用nivolumab和CRT是安全的,并且在局部发达的宫癌中显示出有希望的PFS率.
- 免疫特征与治疗反应相关,这表明需要进一步研究免疫激活子集.
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