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可切除头颈部鳞状细胞癌的新辅助免疫治疗:最新系统评价与荟萃分析

Neoadjuvant Immunotherapy in Resectable HNSCC: An Updated Systematic Review and Meta-analysis.

作者信息

Widjaja Winy, Ng Irene, Shannon Nicolas, Iyer N Gopalakrishna

机构信息

Department of Head and Neck Surgery, National Cancer Centre Singapore, Singapore, Singapore.

出版信息

Ann Surg Oncol. 2025 Apr;32(4):2713-2724. doi: 10.1245/s10434-024-16587-w. Epub 2024 Dec 7.

Abstract

BACKGROUND

Immunotherapy is a recently recognised FDA-approved treatment for R/M HNSCC. Our goal is to explore the safety profile and the efficacy of immunotherapy in the neoadjuvant setting before surgery in mucosal head and neck cancer.

METHODS

Three electronic databases had been systematically searched through March 2024. Demographic and tumour characteristics were extracted. Primary outcomes obtained were disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), complete pathological response (cPR), which was defined as no residual tumour, and major pathological response (MPR), which as defined as <10% residual viable tumour. Safety outcomes examined were grade 3 and above adverse event, median time to surgery, delays to surgery, and death related to neoadjuvant treatment.

RESULTS

A total of 459 patients from 15 studies were included in the analysis. The pooled estimate of cPR for all the studies was 14.9% (95% confidence interval [CI] 8.0-26.2). Subgroup analysis showed chemoimmunotherapy had a higher cPR 30.1% (95% CI 22.8-38.62) compared with immunotherapy alone 1.4% (95% CI 0.3-5.2). There was no treatment-related death. Chemoimmunotherapy had a higher pooled estimate of adverse events 22.9% (95% CI 11.0-41.5) compared with immunotherapy alone 8.5% (95% CI 2.6-24.3). Subgroup analysis demonstrated that chemoimmunotherapy had a higher DFS compared with immunotherapy alone: 89.8% (95% CI 81.4-94.7) versus 80.44% (95% CI 73.9-85.7), respectively. Neoadjuvant immunoradiotherapy had conflicting results.

CONCLUSIONS

Neoadjuvant immunotherapy was well tolerated. Neoadjuvant chemoimmunotherapy may be more effective in treating LAHNSCC over immunotherapy alone; however, TRAEs were higher.

摘要

背景

免疫疗法是美国食品药品监督管理局(FDA)最近批准的用于复发/转移性头颈部鳞状细胞癌(R/M HNSCC)的治疗方法。我们的目标是探讨免疫疗法在黏膜头颈癌术前新辅助治疗中的安全性和疗效。

方法

截至2024年3月,系统检索了三个电子数据库。提取了人口统计学和肿瘤特征。获得的主要结局包括无病生存期(DFS)、无进展生存期(PFS)、总生存期(OS)、完全病理缓解(cPR,定义为无残留肿瘤)和主要病理缓解(MPR,定义为残留存活肿瘤<10%)。检查的安全性结局包括3级及以上不良事件、中位手术时间、手术延迟以及与新辅助治疗相关的死亡。

结果

分析纳入了来自15项研究的459例患者。所有研究的cPR合并估计值为14.9%(95%置信区间[CI] 8.0 - 26.2)。亚组分析显示,与单纯免疫疗法(1.4%,95% CI 0.3 - 5.2)相比,化疗免疫疗法的cPR更高,为30.1%(95% CI 22.8 - 38.62)。没有与治疗相关的死亡。与单纯免疫疗法(8.5%,95% CI 2.6 - 24.3)相比,化疗免疫疗法的不良事件合并估计值更高,为22.9%(95% CI 11.0 - 41.5)。亚组分析表明,化疗免疫疗法的DFS高于单纯免疫疗法:分别为89.8%(95% CI 81.4 - 94.7)和80.44%(95% CI 73.9 - 85.7)。新辅助免疫放疗的结果存在矛盾。

结论

新辅助免疫疗法耐受性良好。新辅助化疗免疫疗法在治疗局部晚期头颈部鳞状细胞癌(LAHNSCC)方面可能比单纯免疫疗法更有效;然而,治疗相关不良反应(TRAEs)更高。

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