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Updated: Sep 19, 2026
Testing Cancer Immunotherapeutics in a Humanized Mouse Model Bearing Human Tumors
Published on: December 16, 2022
Efficacy and Safety of TKI Plus PD-1/PD-L1 Versus Monotherapy in Advanced HNSCC: A Systematic Review and
Zhengyan Luo1, Xiyu Hu1, Dongtao Wang2
1School of Stomatology, Fujian Medical University, Fuzhou, China.
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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