头支状细胞癌 (OpRAH) 息的最佳辐射剂量 - 一个第三阶段随机对照试验
Supriya Mallick1, Abhilash Dagar1, Adrija Ghosh1
1Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.
概括
这一第三阶段试验比较了每周两次用于头癌的息性放射治疗方案. 剂量升级并没有显著改善无进展生存率或整体生存率,但耐受性良好.
科学领域:
- 在瘤学瘤学.
- 辐射瘤学 辐射瘤学
- 临床试验 临床试验
背景情况:
- 息性放射疗法是局部发达的头部和部状细胞癌 (HNSCC) 的常见疗法.
- 对于息性HNSCC的最佳辐射剂量分化仍然没有定义.
- 目前正在探索低分离疗法,以平衡疗效和毒性.
研究的目的:
- 为了在局部发达HNSCC的患者中比较两周的低分离放射治疗方案.
- 评估剂量升级对无进展生存期 (PFS) 和总生存期 (OS) 的影响.
- 评估急性毒性和生活质量.
主要方法:
- 一项3期随机对照试验,涉及305名非转移局部发达HNSCC的患者.
- 患者被随机分配,接受20 Gy分为5个小部分或30 Gy分为5个小部分,每周一次.
- 记录了无进展生存 (PFS),总生存 (OS) 和急性毒性 (使用HN QLQ 43).
主要成果:
- 随访时间中位数为13.9个月. 队列中PFS和OS的中位数分别为7.4个月和10.03个月.
- 在两个放射治疗手臂之间没有观察到PFS (p=0.553) 或OS (p=0.203) 的显著差异.
- 毒性率相似,剂量升级被很好地容忍. 更好的性能状态与改进的操作系统相关.
结论:
- 这项大型的3期RCT表明,在每周缓解性放射治疗中增加HNSCC的剂量不会改善PFS或OS.
- 经过测试的低分化疗法是安全的,耐受性良好.
- 进一步的研究可能将重点放在替代分成方案或组合疗法上,以改善结果.
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