Efficacy and Safety of TKI Plus PD-1/PD-L1 Versus Monotherapy in Advanced HNSCC: A Systematic Review and Meta-Analysis.

IF 3.1 3区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Oral diseases Pub Date : 2026-09-17 DOI:10.1111/odi.70464

Zhengyan Luo, Xiyu Hu, Dongtao Wang

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引用次数: 0

Abstract

Background: PD-1/PD-L1 inhibitors are standard therapy for advanced head and neck squamous cell carcinoma (HNSCC), but benefit only a subset of patients. Combining tyrosine kinase inhibitors (TKIs) with immunotherapy may improve outcomes.

Methods: Following PRISMA 2020, PubMed, Embase, Cochrane Library and Web of Science were searched through January 2026 for clinical trials of PD-1/PD-L1 inhibitor monotherapy or TKI combination therapy in advanced HNSCC. Primary and secondary outcomes were objective response rate (ORR), 1-year overall survival (OS), median OS, progression-free survival (PFS) and safety. Random-effects meta-analyses, risk-of-bias assessment and GRADE evaluation were performed.

Results: Eleven trials including 1190 patients were analysed. Combination therapy achieved a higher pooled ORR than monotherapy (36.2% vs. 16.6%; odds ratio 2.79, 95% CI 1.89-4.12; p < 0.001). The pooled 1-year OS rate was also higher with combination therapy (63.8% vs. 37.8%). Median PFS ranged from 3.2 to 14.6 months with combination therapy and 1.8-3.0 months with monotherapy. Grade ≥ 3 adverse events, including hypertension, proteinuria and hand-foot syndrome, were more frequent but manageable.

Conclusion: TKI plus PD-1/PD-L1 inhibition improves tumour response and may prolong survival, although evidence is limited by small early-phase studies, heterogeneity and cross-trial confounding.

Systematic review registration: PROSPERO CRD1297918.

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TKI联合PD-1/PD-L1与单药治疗晚期HNSCC的疗效和安全性：一项系统综述和荟萃分析

背景：PD-1/PD-L1抑制剂是晚期头颈部鳞状细胞癌（HNSCC）的标准治疗方法，但仅对一小部分患者有效。酪氨酸激酶抑制剂（TKIs）联合免疫治疗可能改善预后。方法：根据PRISMA 2020，检索PubMed、Embase、Cochrane Library和Web of Science截至2026年1月的PD-1/PD-L1抑制剂单药或TKI联合治疗晚期HNSCC的临床试验。主要和次要结局是客观缓解率（ORR）、1年总生存期（OS）、中位生存期（OS）、无进展生存期（PFS）和安全性。进行随机效应荟萃分析、偏倚风险评估和GRADE评估。结果：共分析了11项试验1190例患者。联合治疗的总ORR高于单药治疗（36.2% vs. 16.6%；优势比2.79,95% CI 1.89-4.12; p）结论：TKI加PD-1/PD-L1抑制可改善肿瘤反应，并可能延长生存期，尽管证据受到早期小型研究、异质性和交叉试验混淆的限制。系统评价注册：PROSPERO CRD1297918。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oral diseases 医学-牙科与口腔外科

CiteScore

7.60

自引率

5.30%

发文量

325

审稿时长

4-8 weeks

期刊介绍： Oral Diseases is a multidisciplinary and international journal with a focus on head and neck disorders, edited by leaders in the field, Professor Giovanni Lodi (Editor-in-Chief, Milan, Italy), Professor Stefano Petti (Deputy Editor, Rome, Italy) and Associate Professor Gulshan Sunavala-Dossabhoy (Deputy Editor, Shreveport, LA, USA). The journal is pre-eminent in oral medicine. Oral Diseases specifically strives to link often-isolated areas of dentistry and medicine through broad-based scholarship that includes well-designed and controlled clinical research, analytical epidemiology, and the translation of basic science in pre-clinical studies. The journal typically publishes articles relevant to many related medical specialties including especially dermatology, gastroenterology, hematology, immunology, infectious diseases, neuropsychiatry, oncology and otolaryngology. The essential requirement is that all submitted research is hypothesis-driven, with significant positive and negative results both welcomed. Equal publication emphasis is placed on etiology, pathogenesis, diagnosis, prevention and treatment.