术后放射疗法 ± Cetuximab用于中等风险的头癌
Mitchell Machtay1, Pedro A Torres-Saavedra2,3, Wade Thorstad4
1Penn State Milton S Hershey Medical Center, Hershey, PA.
概括
放射治疗加上 cetuximab 改善了无病生存率,但并没有改善切除头癌的整体生存率. 这种组合疗法适用于选择HPV阴性患者,观察到急性毒性增加.
科学领域:
- 在瘤学瘤学.
- 头部和部癌症研究研究
- 辐射瘤学 辐射瘤学
背景情况:
- 放射治疗 (RT) 与 cetuximab (C) 结合已显示在局部晚期头癌的治疗方面具有前途.
- 这项研究调查了RT + C在完全切除的中期风险状细胞癌 (SCCHN) 患者的疗效.
研究的目的:
- 评估是否添加 cetuximab 给术后放射治疗改善了切除,中等风险 SCCHN.患者的整体存活期 (OS).
- 评估对无病生存率 (DFS) 和毒性的影响,特别是在人类乳头瘤病毒 (HPV) 阴性亚群中.
主要方法:
- 一个随机对照试验,比较强度调节的RT (60-66 Gy) 与每周使用塞图西马布的RT与单独使用RT在577名符合条件的SCCHN患者中.
- 主要终点是OS;次要终点包括DFS和毒性,使用分层日志等级和费舍尔的精确测试进行分析.
主要成果:
- 虽然OS没有显著改善 (5年OS: 76.5%vs68.7%),但RT + C显著改善了DFS (5年DFS: 71.7%vs63.6%).
- 仅在HPV阴性子组中观察到生存益处. 3-4级急性毒性与RT + C (70.3%与39.7%) 较高,但长期毒性相似.
- 在这两只手臂中都没有报告5级毒性.
结论:
- 与单独的RT相比,RT + C提供了显著的DFS好处,而不会增加长期毒性,对于切除的中等风险SCCHN,RT + C提供了显著的DFS好处.
- 这种组合是精心挑选的HPV阴性SCCHN患者的可行治疗选择.
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