Clin Cancer Res:局部晚期头颈部鳞状细胞癌的新辅助化疗+免疫治疗

2022-07-04 MedSci原创 MedSci原创

新辅助化疗联合卡瑞利珠单抗治疗局部晚期头颈部鳞状细胞癌可获得高客观缓解率、病理完全缓解率和主要病理缓解率

目前,局部晚期头颈部鳞状细胞癌(HNSCC)的标准疗法是手术切除后进行风险适应的辅助放疗或同步放化疗。但是,尽管采用了这种积极的联合治疗,但人乳头状瘤病毒(HPV)阴性的局部晚期HNSCC患者的复发、远处转移和死亡风险均仍差强人意。

本研究目的是评估新辅助化疗联合抗PD-1抑制剂卡瑞利珠单抗(Camrelizumab)在局部晚期HNSCC患者中的抗肿瘤活性和安全性。

这是一项单中心、单臂的2期试验,予以不可切除的III_IVB期HNSCC患者化疗(紫杉醇或多西他赛+顺铂)+卡瑞利珠单抗(第1天/21天)治疗3个疗程,然后手术,再予以辅助放疗。主要终点是病理完全缓解率(pCR)和安全性。


一位61岁IVA期患者治疗前后的肿瘤变化

共招募了30位患者,均完成了新辅助治疗。中位随访了16.1个月,客观缓解率为96.7%。27位患者顺利进行了手术,R0切除率高达92.6%(25/27)。临床至病理降期率为100%(27/27)。病理完全缓解率为37.0%,主要病理缓解率是74.1%。12个月时的无病生存率是95.8%。


治疗相关不良反应

3级辅助治疗相关不良反应有丘疹(1例,3.3%)、瘙痒(1例,3.3%)和血小板减少症(1例,3.3%);无4级或5级治疗相关不良反应发生。最常见的手术并发症是迟发性伤口出血(5例,18.5%)。

综上,新辅助化疗联合卡瑞利珠单抗治疗局部晚期头颈部鳞状细胞癌可获得高客观缓解率、病理完全缓解率和主要病理缓解率,而且安全性好。该研究结果支持进一步评估该方案在该患者人群中的应用前景。

 

原始出处:

Zhanjie Zhang, Bian Wu, Gang Peng, et al. Neoadjuvant Chemoimmunotherapy for the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Clinical Trial. Clin Cancer Res 2022; https://doi.org/10.1158/1078-0432.CCR-22-0666

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    2022-07-04 docwu2019
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    2022-07-04 wshxjq
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