局部晚期头颈部鳞状细胞癌免疫治疗MDT专家共识（2025年版）

doi:10.19401/j.cnki.1007-3639.2025.11.010

摘要/Abstract

摘要：

约2/3的头颈部鳞状细胞癌患者就诊时处于局部晚期，即便采用多学科团队（multidisciplinary team，MDT）的诊疗模式，其治疗结局仍有待改进。免疫治疗已经成为复发转移性头颈部鳞状细胞癌的标准治疗，近年来在局部晚期特别是围手术期的临床研究中获得了初步成功，但在不同场景具体应用方面依然面临诸多问题。中国临床肿瘤学会头颈肿瘤专家委员会组织专家基于循证医学证据及临床实践探索，经过多轮讨论，最终形成14条共识意见。本共识全面涵盖局部晚期头颈部鳞状细胞癌免疫治疗的各种治疗场景，归纳如下：① 在全程治疗策略方面，对于拟接受根治性手术及辅助放化疗的局部晚期头颈部鳞状细胞癌患者，推荐采用新辅助免疫治疗、免疫治疗联合放化疗及辅助免疫治疗的全程治疗模式。② 在新辅助治疗阶段，对于需要进行新辅助免疫治疗的患者，建议选择免疫治疗联合化疗方案，疗程为2~3个周期；对于新辅助治疗后影像学评估显示肿瘤缓解且需要保留器官功能的非口腔癌患者，应采用根治性放疗。③ 免疫治疗联合放疗阶段目前尚存在争议，其最佳治疗方案和适用人群有待进一步临床研究探索。④ 在辅助免疫治疗阶段，对于具有高危因素的局部晚期头颈部鳞状细胞癌患者，术后推荐采用辅助放疗联合免疫治疗的综合方案，辅助免疫治疗的疗程为6~12个月。本共识将有利于指导局部晚期头颈部鳞状细胞癌免疫治疗的规范化应用，并且为下一步的临床研究奠定基础，力求提高国内局部晚期头颈部鳞状细胞癌免疫治疗的研究水平。本共识已在国际实践指南注册与透明化平台（Practice guideline REgistration for transPAREncy，PREPARE）上注册，注册号为PREPARE-2025CN1241。

关键词: 局部晚期头颈部鳞状细胞癌, 多学科诊疗, 免疫治疗, 免疫检查点抑制剂, 专家共识

Abstract:

Approximately two-thirds of patients with head and neck squamous cell carcinoma present with locally advanced disease at the time of consultation. Even with the multidisciplinary team (MDT) diagnosis and treatment model, their treatment outcomes still need improvement. Immunotherapy has become the standard treatment for recurrent and metastatic head and neck squamous cell carcinoma. In recent years, it has achieved initial success in clinical studies on locally advanced diseases, especially in the perioperative period, but its application in other treatment fields still faces many problems. The Head and Neck Cancer Committee of Chinese Society of Clinical Oncology organized experts to form 14 consensus opinions through multiple rounds of discussions informed by evidence-based medical evidence and clinical practice. Thess consensus statements were finally formulated, comprehensively covering the entire management of immunotherapy for locally advanced head and neck squamous cell carcinoma, summarized as follows: ① Regarding the whole-course treatment strategy, for patients with locally advanced head and neck squamous cell carcinoma undergoing radical surgery followed by adjuvant chemoradiotherapy, a comprehensive treatment approach combining neoadjuvant immunotherapy, immunotherapy combined with chemoradiotherapy, and adjuvant immunotherapy is recommended. ② In the neoadjuvant treatment phase, for patients requiring neoadjuvant immunotherapy, the combination of immunotherapy with chemotherapy is recommended, with a course of 2-3 cycles. For non-oral cancer patients who achieve radiological tumor response after neoadjuvant treatment and require organ preservation, definitive radiotherapy should be administered. ③ The immunotherapy combined with radiotherapy phase remains controversial, and the optimal treatment regimen and patient selection criteria require further clinical investigation. ④ In the adjuvant immunotherapy phase, for locally advanced head and neck squamous cell carcinoma patients with high-risk factors, the combination of adjuvant radiotherapy with immunotherapy is recommended postoperatively, with a course of adjuvant immunotherapy ranging from 6 to 12 months. Corresponding recommendation levels for different treatment scenarios are obtained through voting. This consensus will help guide the standardized application of immunotherapy for locally advanced head and neck squamous cell carcinoma, lay the foundation for further clinical research, and strive to promote the research level of immunotherapy for locally advanced head and neck squamous cell carcinoma in China.This consensus has been registered on the Practice guideline REgistration for transPAREncy (PREPARE) platform, with the registration number PREPARE-2025CN1241.

Key words: Locally advanced head and neck squamous cell carcinoma, Multidisciplinary treatment, Immunotherapy, Immune checkpoint inhibitor, Expert consensus

中图分类号:

R739.91

郭晔, 胡超苏, 张陈平. 局部晚期头颈部鳞状细胞癌免疫治疗MDT专家共识（2025年版）[J]. 中国癌症杂志, 2025, 35(11): 1076-1089.

GUO Ye, HU Chaosu, ZHANG Chenping. MDT consensus on immunotherapy for locally advanced head and neck squamous cell carcinoma (2025 edition)[J]. China Oncology, 2025, 35(11): 1076-1089.

图/表 4

表1

表2

表3

局部晚期头颈部鳞状细胞癌新辅助免疫治疗的前瞻性研究汇总"

研究	临床研究类型	样本量	研究方案	主要结果
Li X, et al^[10]	Ⅱ期	163	A组：TPF（2个周期）→手术+术后辅助放（化）疗； B组：信迪利单抗+TPF（2个周期）→手术+术后辅助放（化）疗	A组与B组相比，ORR分别为68.4%和84.6%，2年PFS率分别为27%和44%，2年OS率分别为61%和70%
Wise-Draper T M, et al^[11]	Ⅱ期	92	帕博利珠单抗（1个周期）→手术+帕博利珠单抗（6个周期）+术后辅助放（化）疗	1年DFS率为80%，中低危组1年DFS率97%，高危组1年DFS率为66%，MPR率为7%
Ju WT, et al^[12]	Ⅱ期	20	卡瑞利珠单抗+阿帕替尼（3个周期）→手术+术后辅助放（化）疗	MPR率为40%，18个月OS率为95%，18个月局部复发率为10.5%
Huang X, et al^[13]	Ⅱ期	23	特瑞普利单抗+GP（2个周期）→手术+术后辅助放（化）疗	pCR率为16.7%，MPR率为27.8%，ORR为45%
Zhang Z, et al^[14]	Ⅱ期	30	卡瑞利珠单抗+nab-TP（3个周期）→手术+术后辅助放（化）疗	pCR率为37%，MPR率为74.1%，ORR为96.7%，降期率为100%
Huang Y, et al^[15]	Ⅱ期	20	特瑞普利单抗+nab-TP（2个周期）→手术+术后辅助放（化）疗	pCR率为30%，MPR率为60%，2年OS率为95%，2年DFS率为90%
Wu W, et al^[16]	Ⅱ期	31	替雷利珠单抗+nab-TP（2个周期）→手术+术后辅助放（化）疗	pCR率为41.4%，MPR率为65.5%，CR率为65.5%，ORR为61.3%
Ou X, et al^[17]	Ⅱ期	27	特瑞普利单抗+TP（3个周期）→CR/PR患者：同期放化疗+特瑞普利单抗（8个周期）；SD/PD患者：手术+术后辅助放（化）疗+特瑞普利单抗（8个周期）	ORR为85.2%，1年OS率为84.7%，1年PFS率为77.6%，1年LPR为88.7%
Gong H, et al^[18]	Ⅱ期	51	卡瑞利珠单抗+TP+卡培他滨（3个周期）→CR/PR患者：同期放化疗+卡瑞利珠单抗（18个周期）；SD/PD患者：手术+术后辅助放（化）疗+卡瑞利珠单抗（18个周期）	ORR为82.4%，2年OS率为83%，2年PFS率为77.1%，2年LPR为70%
Wu D, et al^[19]	Ⅱ期	48	卡瑞利珠单抗+nab-TP（3个周期）→CR/PR的喉癌或下咽癌患者：接受同期放化疗；口腔癌、口咽癌、SD/PD的喉癌或下咽癌患者：手术+术后辅助放（化）疗	ORR为89.6%，pCR率为55.6%，病理学降期率为77.8%，1年OS率和PFS率均为97.9%
Dunn L, et al^[20]	Ⅱ期	30	西米普利单抗+含铂双药+西妥昔单抗（3个周期）→手术+术后辅助放化疗或MPR以上患者：西米普利单抗（8个周期）	pCR率为31%，MPR率为66%
Uppaluri R, et al^[7]	Ⅲ期	714	试验组：帕博利珠单抗（2个周期）→手术+术后辅助放（化）疗同期帕博利珠单抗（3个周期）+帕博利珠单抗维持（12个周期）；对照组：手术+术后放（化）疗	ITT人群试验组与对照组相比，中位EFS分别为51.8和30.4个月（HR=0.73，95% CI：0.58~0.92，P=0.041）
Gui L, et al^[21]	Ⅱ期	45	替雷利珠单抗+nab-TP（2个周期）→CR/PR患者：同期放化疗或喉保留手术；SD/PD患者：手术+术后放（化）疗	3个月的保喉率为86.7%，ORR和DCR分别为62.2%和100.0%，1年LPS率、PFS率和OS率分别为66.7%、69.8%和77.4%
Yang K Y, et al^[22]	Ⅱ期	50	派安普利单抗+nab-TP（3个周期）→手术+术后辅助放（化）疗+派安普利单抗（9个周期）	pCR率为40.7%，ORR为96%；2年EFS率为89.28%，2年OS率为92.85%
Wang H L, et al^[23]	Ⅱ期随机对照试验	122	A组：特瑞普利单抗+nab-TP（3个周期）→手术+术后辅助放（化）疗； B组：nab-TP（3个周期）→手术+术后辅助放（化）疗	A组与B组相比，pCR率分别为57.78%和34.88%，MPR率分别为82.22%和53.46%，2年DFS率为86.67%和71.95%，2年OS率为90.61%和77.74%
Yan S, et al^[24]	Ⅱ期	27	信迪利单抗+nab-TP（2个周期）→手术+术后辅助放（化）疗	pCR率为68%，ORR为100%
Liu Z, et al ^[25]	Ⅱ期	28	替雷利珠单抗+低剂量放疗+nab-TP（2个周期）→手术+术后辅助放（化）疗	pCR率为60.9%，MPR率为82.6%，CR率为7.1%，ORR为64.3%
Xiang Z, et al^[26]	Ⅱ期	33	卡瑞利珠单抗+nab-TP（2个周期）→手术+术后辅助放（化）疗	pCR率为41.4%，MPR率为69.0%，ORR为82.8%

表3

表4

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[46]	PEARSON A T, SEIWERT T Y, COHEN R B, et al. A randomized, double-blind, placebo-controlled phase Ⅱ study of adjuvant pembrolizumab versus placebo in patients with head and neck squamous cell cancers at high risk for recurrence: the PATHWay study[J]. J Clin Oncol, 2024, 42(16_suppl): 6008.

证据级别	描述
Ⅰ	至少一项设计良好的大型随机对照试验（偏倚可能性很小）或基于高质量随机对照试验的meta分析
Ⅱ	方法学质量低的大型随机对照试验（存在偏倚嫌疑）或小型随机对照试验或基于此类试验的meta分析
Ⅲ	非随机对照的前瞻性队列研究
Ⅳ	回顾性队列研究或病例对照研究
Ⅴ	病例报告、专家意见

推荐等级	描述
A	具有显著临床获益的强有力的疗效数据，强烈推荐
B	具有强有力或中等的疗效数据，但临床获益有限，弱推荐
C	疗效证据不充分，或临床获益与风险接近（安全性、成本效益等），谨慎推荐
D	中等的疗效数据证明疗效欠佳或不良反应太大，通常不推荐
E	强有力的疗效数据证明疗效欠佳或不良反应太大，强烈不推荐

研究	临床研究类型	研究人群	样本量	治疗方案
NIVOPOSTOP研究^[42]	Ⅲ期	局部晚期头颈部鳞状细胞癌具有高复发风险的病理学特征（结节包膜外侵、肿瘤切缘呈阳性、淋巴结侵犯≥4个，多发神经周围浸润）	680	纳武利尤单抗：+CRT vs CRT 纳武利尤单抗：240 mg 1个周期（CRT前）+360 mg 3个周期（CRT同期，每3周1次）+480 mg 6个周期（CRT后，每4周1次）（免疫治疗8.75个月）
Leddon J L, et al^[44]	Ⅱ期	局部区域复发性头颈部鳞状细胞癌接受挽救性手术后的患者	39	纳武利尤单抗：240 mg，12个周期（每2周1次），或480 mg，共6个周期（每4周1次）（免疫治疗6个月）
ADJORL1研究^[45]	Ⅱ期	局部区域复发性头颈部鳞状细胞癌接受挽救性手术后的患者	57	纳武利尤单抗：240 mg，5个周期（每2周1次）+ 480 mg，3个周期（每4周1次）（免疫治疗5.5个月）
Pathway研究^[46]	Ⅱ期随机对照试验	局部区域复发性头颈部鳞状细胞癌接受挽救性治疗后具有高复发风险的患者	100	帕博利珠单抗 vs 安慰剂帕博利珠单抗：200 mg，16个周期或1年（每3周1次）（免疫治疗12个月）