口腔疾病防治2026，Vol.34Issue(2)：105-118,14.DOI:10.12016/j.issn.2096-1456.202550582
局部晚期口腔鳞状细胞癌PD-1抑制剂新辅助治疗专家共识(2026年版)
Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma(2026 edi-tion)
摘要
Abstract
Oral squamous cell carcinoma(OSCC)is a common head and neck malignancy.Approximately 50%to 60%of patients with OSCC are diagnosed at a locally advanced stage(clinical staging III-IVa).Even with systemic and sequential treatment primarily based on surgery,the 5-year overall survival rate remains below 50%,and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing.Programmed death receptor-1(PD-1)inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy.However,clinical practice still faces key challenges,including the definition of indications,optimization of combination regimens,and standards for efficacy evaluation.Based on the latest research advances worldwide and the clinical experience of the expert group,this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC,covering combination strategies,treatment cycles and surgical timing,efficacy assessment,use of biomarkers,management of special populations and immune re-lated adverse events,principles for immunotherapy rechallenge,and function preservation strategies.After multiple rounds of panel discussion and through anonymous voting using the Delphi method,the following consensus statements have been formulated:1)Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC.The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy,administered for 2-3 cycles.2)During the efficacy evaluation of neoadjuvant therapy,radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 and immune RECIST(iRECIST).After surgery,systematic pathological evaluation of both the primary lesion and regional lymph nodes is required.For combi-nation chemotherapy regimens,PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria.3)For special populations such as the elderly(≥70 years),individuals with stable HIV viral load,and carriers of chronic HBV/HCV,PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team(MDT),with close monitoring for adverse events.4)For patients with a poor response to neoadjuvant therapy,con-tinuation of the original treatment regimen is not recommended;the subsequent treatment plan should be adjusted promptly after MDT assessment.Organ transplant recipients and patients with active autoimmune diseases are not rec-ommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation.Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune me-diated myocarditis,neurotoxicity,or pneumonitis.5)For patients with a good pathological response,individualized de-escalation surgery and function preservation strategies can be explored.This consensus aims to promote the standard-ized,safe,and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.关键词
口腔鳞状细胞癌/局部晚期/新辅助治疗/PD-1抑制剂/免疫治疗/疗效评估/免疫相关不良反应/联合阳性评分/功能性外科/化疗Key words
oral squamous cell carcinoma/locally advanced stage/neoadjuvant treatment/PD-1 inhibitor/immunotherapy/efficacy evaluation/immune-related adverse reactions/combined positive score/functional sur-gery/chemotherapy分类
医药卫生引用本文复制引用
李劲松,魏建华,季彤,李春洁,林李嵩,任国欣,李一,尚伟,韩冰,蒋灿华,张胜,廖贵清,宋明,刘学奎,王安训,刘曙光,陈展洪,王友元,林钊宇,李海刚,段小慧,叶玲,李龙江,郑军,王军,吕晓智,朱李军,曹昊天,张陈平,尚政军,张杰,钟来平,刘冰,陈刚..局部晚期口腔鳞状细胞癌PD-1抑制剂新辅助治疗专家共识(2026年版)[J].口腔疾病防治,2026,34(2):105-118,14.基金项目
国家自然科学基金(82472823) This study was supported by the grants from National Natural Science Foundation of China(No.82472823). （82472823）
