Wang JX, Wang TX, Song YT, Xu GH, Zhang YB, Zhang B. Efficacy of two programmed cell death 1 combination regimens in recurrent and/or metastatic head and neck carcinoma: A real-world retrospective study. World J Clin Oncol 2026; 17(9): 124416 [DOI: 10.5306/wjco.124416]
Corresponding Author of This Article
Bin Zhang, Department of Head and Neck Surgery, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. docbinzhang@hotmail.com
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Oncology
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research-article
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Wang JX, Wang TX, Song YT, Xu GH, Zhang YB, Zhang B. Efficacy of two programmed cell death 1 combination regimens in recurrent and/or metastatic head and neck carcinoma: A real-world retrospective study. World J Clin Oncol 2026; 17(9): 124416 [DOI: 10.5306/wjco.124416]
Jia-Xin Wang, Tian-Xiao Wang, Yun-Tao Song, Guo-Hui Xu, Ya-Bing Zhang, Bin Zhang, Department of Head and Neck Surgery, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing 100142, China
Co-first authors: Jia-Xin Wang and Tian-Xiao Wang.
Author contributions: Wang JX and Wang TX contributed to conceptualization, methodology, and manuscript drafting; Song YT, Xu GH and Zhang YB supervised the study and revised the manuscript; Zhang B was responsible for study supervision, project administration, critical review of the manuscript and final approval of the submitted version. All authors read and approved the final manuscript. Wang JX and Wang TX contributed equally to this work as co-first authors.
AI contribution statement: Portions of this manuscript were edited using AI tools solely for language refinement. The authors carefully reviewed and verified all AI-assisted outputs and take full responsibility for the scientific content of the manuscript.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of Peking University Cancer Hospital (No. 2019YJZ12).
Informed consent statement: Written informed consent was obtained from all patients or their relatives.
Conflict-of-interest statement: The authors declare no competing interests.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Corresponding author: Bin Zhang, Department of Head and Neck Surgery, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. docbinzhang@hotmail.com
Received: June 15, 2026 Revised: August 5, 2026 Accepted: September 22, 2026 Published online: September 24, 2026 Processing time: 101 Days and 0.1 Hours
Abstract
BACKGROUND
The combination of programmed cell death 1 (PD-1) inhibitors with molecularly targeted agents, including anti-epidermal growth factor receptor monoclonal antibody (cetuximab) and multi-targeted tyrosine kinase inhibitor (such as anlotinib), has emerged as promising therapeutic strategies in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, comparisons of efficacy between the dual-agent regimens remain unexplored.
AIM
To evaluate the comparative survival benefits and treatment responses of PD-1 inhibitor plus cetuximab vs PD-1 inhibitor plus anlotinib in R/M HNSCC.
METHODS
In this real-world study, 24 patients who received PD-1 inhibitors combined with targeted agents at Peking University Cancer Hospital between November 2018 and May 2024 were retrospectively assessed. Patients were stratified into two groups: Anti-PD-1 plus cetuximab (n = 13) and anti-PD-1 plus anlotinib (n = 11). Clinical characteristics and follow-up outcomes were collected, and the overall response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) of the two strategies were analyzed.
RESULTS
The anti-PD-1 plus cetuximab group achieved an ORR of 27.3% and a DCR of 90.9%, while the anti-PD-1 plus anlotinib group showed an ORR of 40.0% and a DCR of 100%. The anti-PD-1 plus cetuximab group demonstrated significantly prolonged OS compared to the anti-PD-1 plus anlotinib group (19.2 months vs 5.8 months; hazard ratios = 0.37; P = 0.036). Survival benefits were consistently observed in subgroups, including patients with programmed death-ligand 1 combined positive score (CPS) ≥ 20 (29.7 months vs 4.1 months; P = 0.013), CPS ≥ 1 (29.7 months vs 4.1 months; P = 0.034), and those receiving first-line treatment (29.7 months vs 4.4 months; P = 0.024). PFS differences were not statistically significant (6.5 months vs 4.4 months, P = 0.448).
CONCLUSION
Both combination strategies showed antitumor activity in R/M HNSCC. In this retrospective real-world cohort, PD-1 inhibitor plus cetuximab was associated with prolonged OS, whereas PD-1 inhibitor plus anlotinib showed favorable disease control. Larger prospective studies are warranted to confirm these findings.
Core Tip: Programmed cell death 1 (PD-1) inhibitors combined with cetuximab or anlotinib exhibit distinct therapeutic profiles in recurrent and/or metastatic head and neck squamous cell carcinoma. In this real-world cohort study, PD-1 inhibitor plus cetuximab was associated with significantly prolonged overall survival, whereas PD-1 inhibitor plus anlotinib showed favorable tumor response and disease control. These distinct efficacy profiles may help inform individualized treatment selection for PD-1-based immunotherapy-targeted therapy combinations.
