内增强放射性纳米粒子NBTXR3,随后在头癌中进行放射治疗:一期剂量扩大非随机临床试验
Christophe Le Tourneau1, Xavier Liem2, France Nguyen3
1Department of Therapeutic Innovation and Early Trials (DITEP), Institut Gustave Roussy, Villejuif, France.
JAMA otolaryngology-- head & neck surgery
|January 29, 2026
概括
内NBTXR3加辐射疗法 (RT) 在局部发达的头部和部状细胞癌 (HNSCC) 患者中显示出有前途的安全性和有效性,无法接受全身治疗. 这支持在III期试验中进一步评估.
科学领域:
- 在瘤学瘤学.
- 辐射瘤学 辐射瘤学
- 头部和部癌症 头部和部癌症
背景情况:
- 局部发达的头部和部状细胞癌 (HNSCC) 构成治疗挑战,特别是对于那些无法接受标准全身治疗的患者,如思丁或 cetuximab.
- NBTXR3,一种新型的放射增强剂,通过增强内治疗时放射治疗 (RT) 的效果,提供了一种潜在的新方法.
研究的目的:
- 评估NBTXR3与RT结合的安全性和初步疗效,用于局部晚期HNSCC患者,这些患者不能同时接受全身治疗.
- 评估NBTXR3注射初级瘤和所有病变的客观应答率 (ORR),以及无进展生存率 (PFS) 和整体生存率 (OS).
主要方法:
- 一个单臂,第一阶段剂量扩大,非随机临床试验,在20个欧洲中心进行.
- 56名患有不可切除的T3-4或III阶段/IVA HNSCC (口腔或口腔喉) 的患者不符合西斯普拉丁和塞图西马布的条件,接受了NBTXR3单次内注射,然后再接受RT (70 Gy/35分数).
主要成果:
- 与NBTXR3相关的治疗出现的不良事件发生在16%的患者中,11%是3级或更高 (最常见的是口腔炎,4%).
- 在可评估患者 (n=44) 中,注射初级瘤的ORR为82%,所有病变的ORR为80%.
- 在所有56名接受治疗的患者中,PFS的中位数为11.4个月,OS的中位数为18.1个月.
结论:
- 内 NBTXR3 接着 RT 是可行的,在高风险 HNSCC 群体无法接受标准的全身治疗中显示出初步的疗效信号.
- 观察到的益处风险概况支持正在进行的随机第三期试验,该试验评估了该患者组中的NBTXR3加RT.
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