第二阶段的开放性随机对照试验,比较基于酸和酸的同时化学辐射疗法,用于局部发达的头癌
概括
与基斯普拉丁基CCRT相比,基于牛氧的化学辐射疗法 (CCRT) 在局部晚期头癌 (LAHNC) 中显示出明显更好的毒性特征. 这种牛氧的方法在疾病控制方面似乎是可比的,因此在更大的试验中需要进一步调查.
科学领域:
- 在瘤学瘤学.
- 辐射疗法 辐射疗法
- 头部和部癌症 治疗 治疗
背景情况:
- 与西斯普拉丁同时进行化学放射治疗 (CCRT) 是局部晚期头癌 (LAHNC) 的标准.
- 与西斯普拉丁的CCRT与与治疗相关的显著毒性有关.
- 氧酸与酸共享放射敏感化机制.
研究的目的:
- 为了比较CCRT中的oxaliplatin与cisplatin对非鼻LAHNC的毒性概况.
- 为了评估合规性,地方区域控制 (LRC),无病生存率 (DFS) 和整体生存率 (OS) 作为次要终点.
主要方法:
- 在CCRT中,前性试验比较每周使用的氧沙 (50 mg/m2) 与每周使用的西斯 (40 mg/m2).
- 随机分配了70名LAHNC患者 (35名).
- 主要终点:毒性概况;次要终点:合规性,LRC,DFS,OS.
主要成果:
- 3级或更高的急性毒性发生在31%的牛利手臂,而77%的西斯手臂 (P = 0.007).
- 估计的3年和5年的LRC,DFS和OS显示,两支手臂之间没有统计学上显著的差异.
- 随访时间中位数为18个月.
结论:
- 与西斯丁相比,与氧沙丁的CCRT在非鼻喉LAHNC中显示出更高的毒性概况.
- 在疾病控制方面,基于牛津的CCRT似乎与西斯相似.
- 建议进行更大规模的试验,以进一步评估基于oxaliplatin的CCRT的LRC和生存数据.
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