Abstract
Objective
This study aimed to evaluate the efficacy and safety of programmed cell death-1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitor plus chemotherapy vs standard of care (SoC) treatment in the first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/M-SCCHN).
Methods
Randomized controlled trials (RCTs) that investigated PD-1/PD-L1 inhibitor plus chemotherapy vs SoC as first-line treatment for R/M-SCCHN were searched from electronic databases (PubMed, Embase and Cochrane Library). The primary outcomes were overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs).
Results
In total, three phase 3 RCTs (KEYNOTE-048, CAPTAIN-1st, and JUPITER-02; n = 1120) with three PD-1 inhibitors (pembrolizumab, camrelizumab and toripalimab) were included in the analysis. Compared with SoC, PD-1 inhibitor plus chemotherapy significantly prolonged PFS (hazard ratio [HR] 0.66, 95% CI 0.40–0.93, p < 0.001) and OS (HR 0.73, 95% CI 0.60–0.86, p < 0.001) of patients. There was no statistical differences in ORR (odds ratio [OR] 1.26; 95% CI 0.97–1.64, p = 0.086), grade 3 or higher AEs (OR 0.77, 95% CI 0.50–1.17, p = 0.221), and treatment-related deaths (OR 1.34, 95% CI 0.60–2.98, p = 0.470) between the two groups.
Conclusion
PD-1 inhibitor plus chemotherapy showed more survival benefit than SoC in the first-line treatment for R/M-SCCHN, with a similar safety profile.
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Abbreviations
- R/M-SCCHN:
-
Recurrent or metastatic head and neck squamous cell carcinoma
- RCT:
-
Randomized controlled trial
- OS:
-
Overall survival
- PFS:
-
Progression-free survival
- AE:
-
Adverse event
- ORR:
-
Objective response rate
- PD-1:
-
Programmed cell death protein-1
- PD-L1:
-
Programmed cell death 1 ligand 1
- CTLA-4:
-
Cytotoxic T lymphocyte antigen 4
- HR:
-
Hazard ratio
- OR:
-
Odds ratio
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Acknowledgements
The authors would like to thank The Third Affiliated Hospital of Guangxi Medical University.
Funding
This study was funded in part by the Self-Raised Scientific Research Fund of the Ministry of Health of Guangxi Province (Grant/Award number: Z20200080).
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MDC and HJF contributed to the study design and writing. CL and LPH performed the data collection and selection. ZB and WHL performed the data analysis. All authors read and approved the final manuscript.
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Mo, DC., Huang, JF., Luo, PH. et al. PD-1/PD-L1 inhibitor plus chemotherapy versus standard of care in the first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma. Eur Arch Otorhinolaryngol 280, 1–9 (2023). https://doi.org/10.1007/s00405-022-07571-9
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DOI: https://doi.org/10.1007/s00405-022-07571-9