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针对局部晚期可切除口腔状细胞癌的新辅助免疫化学疗法:一个前单臂试验 (Illuminate Trial)

Yingying Huang¹, Jingjing Sun², Jun Li¹

¹Department of Oral and Maxillofacial-Head and Neck Oncology.

International journal of surgery (London, England)

|June 8, 2023

概括

使用托利帕利马布和阿尔伯明帕克利塔塞尔/西斯普拉丁 (TTP) 的新辅助免疫化疗 (NAICT) 是对局部发达的口腔状细胞癌 (LAOSCC) 的安全有效治疗方法. 这种方法显示出有希望的病理反应率和改善的生存结果.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
手术瘤学手术瘤学

背景情况:

局部发达的口腔状细胞癌 (LAOSCC) 具有重大挑战,复发率和死亡率很高.
新辅助免疫化学疗法 (NAICT) 在其他固体瘤中表现有前途,这需要对LAOSCC.进行调查.

研究的目的:

在LAOSCC患者中使用toripalimab和TTP协议评估NAICT的安全性和有效性.
评估在NAICT和激进手术后的病理反应和生存结果.

主要方法:

一项前性试验涉及临床III期和IVA期OSCC患者,接受两轮NAICT (托利帕利马布和TTP),随后进行手术和辅助治疗.
主要终点包括安全性和主要病理反应 (MPR).
使用下一代测序和多重免疫光学分析瘤分子特征和免疫微环境.

主要成果:

纳克特的耐受性很好,严重不良事件的发生率很低.
实现了NAICT和R0切除的100%完成率.
观察到60%的MPR率,其中30%实现了病理完整反应.
三级淋巴结构密度预测了病理反应.
在23个月的随访后,无病生存率为90%,整体生存率为95%.

结论:

与TTP协议一起的NAICT是LAOSCC的可行和耐受性良好的治疗方法.
该方案显示出有希望的MPR率,并促进了后续手术.
结果支持进一步的随机试验,以确认NAICT在LAOSCC的疗效.

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