在高风险的人类乳头瘤病毒驱动的口腔癌中使用化学辐射之前诱导尼沃卢马布:IMMUNEBOOST-HPV,多中心随机二期试验
Haitham Mirghani1,2, Anne Aupérin3, Caroline Even4
1Department of Oto-rhino-laryngology and Head and Neck Surgery, Hôpital Européen Georges Pompidou, AP-HP, University Paris Cité, Paris, France.
概括
在HPV阳性口腔癌的化学辐射前诱导尼沃卢马布显示出较低复发率的趋势,但由于毒性,未达到可行性目标. 需要进一步的研究来证实这些探索性发现.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 高风险的HPV阳性口腔癌 (OPC) 患者面临显著的复发风险.
- 在化疗辐射 (CRT) 之前的诱导免疫疗法正在研究以改善结果.
研究的目的:
- 在高风险的HPV阳性OPC患者中评估CRT前诱导尼沃卢马布的可行性和安全性.
- 评估与这种治疗策略相关的瘤结果和毒性.
主要方法:
- 一个随机的II期试验,比较标准CRT与nivolumab,然后再进行CRT.
- 资格标准包括HPV阳性OPC与晚期或显著的吸烟史.
- 主要终点是患者在适当时间接受完整治疗 (FTDT) 的比例.
主要成果:
- 这项研究没有达到其主要可行性终点,实验组中的10%的患者因毒性而减少了西斯的剂量.
- 4-5级急性不良事件仅在实验组中观察到.
- 与对照组 (15.0%) 相比,nivolumab组的2年累计复发发病率在数值上较低 (7.3%).
结论:
- 在CRT之前的诱导nivolumab没有达到预定义的可行性值.
- 虽然实验组的复发发病率在数值上较低,但这一发现是探索性的,需要确认.
- 导致降低西斯丁剂量的毒性是未达到可行性目标的关键因素.
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