The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study
Open accessAbstract
PURPOSE: Pembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048. Post hoc analysis of long-term efficacy and progression-free survival on next-line therapy (PFS2) is presented. METHODS: Patients were randomly assigned (1:1:1) to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Efficacy was evaluated in programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, CPS ≥ 1, and total populations, with no multiplicity or alpha adjustment. RESULTS: The median study follow-up was 45.0 months (interquartile range, 41.0-49.2; n = 882). At data cutoff (February 18, 2020), overall survival improved with pembrolizumab in the PD-L1 CPS ≥ 20 (hazard ratio [HR], 0.61; 95% CI, 0.46 to 0.81) and CPS ≥ 1 populations (HR, 0.74; 95% CI, 0.61 to 0.89) and was noninferior in the total population (HR, 0.81; 95% CI, 0.68 to 0.97). Overall survival improved with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.62; 95% CI, 0.46 to 0.84), CPS ≥ 1 (HR, 0.64; 95% CI, 0.53 to 0.78), and total (HR, 0.71; 95% CI, 0.59 to 0.85) populations. The objective response rate on second-course pembrolizumab was 27.3% (3 of 11). PFS2 improved with pembrolizumab in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.84) and CPS ≥ 1 (HR, 0.79; 95% CI, 0.66 to 0.95) populations and with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.86), CPS ≥ 1 (HR, 0.66; 95% CI, 0.55 to 0.81), and total (HR, 0.73; 95% CI, 0.61 to 0.88) populations. PFS2 was similar after pembrolizumab and longer after pembrolizumab-chemotherapy on next-line taxanes and shorter after pembrolizumab and similar after pembrolizumab-chemotherapy on next-line nontaxanes. CONCLUSION: With a 4-year follow-up, first-line pembrolizumab and pembrolizumab-chemotherapy continued to demonstrate survival benefit versus cetuximab-chemotherapy in recurrent/metastatic head and neck squamous cell carcinoma. Patients responded well to subsequent treatment after pembrolizumab-based therapy.
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Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer
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Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck
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Self-citationHead and neck squamous cell carcinoma
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Self-citationBurtness, B., Harrington, K. J., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Basté, N., Neupane, P., Bratland, Å., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32591-7 · Cited by 3,336
Self-citationChow, L. Q. M. (2020) · New England Journal of Medicine · doi:10.1056/nejmra1715715 · Cited by 2,075
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Self-citationHead and Neck Cancers, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology
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Metadata
- Authors
- Harrington, K. J., Burtness, B., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Brana, I., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesia, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Lin, J., Gumuscu, B., Swaby, R. F., & Rischin, D.
- Venue
- Journal of Clinical Oncology
- Published
- 2023-02-01
- Volume
- 41
- Issue
- 4
- Pages
- 790-802
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4304474516
- Cited by
- 522
- References
- 15
- FWCI
- 78.92
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Harrington, K. J., Burtness, B., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Brana, I., Basté, N., Neupane, P., Bratland, Å., Fuereder, T., Hughes, B. G. M., Mesia, R., Ngamphaiboon, N., Rordorf, T., Wan Ishak, W. Z., Lin, J., Gumuscu, B., . . . Rischin, D. (2023). Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.02508
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