Pembrolizumab as first-line treatment for recurrent and metastatic head and neck cancer – real-world single-centre data
DOI:
https://doi.org/10.2340/1651-226X.2025.42128Keywords:
Immunotherapy, Head and neck cancer, Real-world dataAbstract
Background and purpose: The randomised clinical trial KEYNOTE-048 has demonstrated a significant increase in survival for patients with head and neck cancer treated with pembrolizumab with or without chemotherapy. The purpose of the present retrospective study was to investigate whether survival in a group of consecutive patients treated at our department was comparable to the results from KEYNOTE-048.
Patients/material and methods: Seventy-six patients initiated treatment with pembrolizumab ± platinum/5-FU between July 2020 and May 2022. Baseline characteristics were collected, response rates and survival times were calculated and compared to those published from KEYNOTE-048.
Results and Interpretation: Fifty-one percent of patients had locoregional recurrence and 47% had distant metastases. Median progression-free survival was 5.5 months, and median overall survival (OS) was 12.3 months in the total cohort. OS was significantly higher for patients with combined positive score (CPS) ≥20 (14.6 months) than for patients with CPS 1–19 (7.3 months) (p = 0.04). There was no significant difference in survival times between patients ± 65 years of age or between patients with locoregional disease versus distant metastases. In conclusion, the results from KEYNOTE-048 were corroborated in a consecutive cohort of patients treated at Rigshospitalet, Copenhagen, Denmark.
Downloads
References
Shah JP, Patel SG, Singh B, Wong R (editors). Jatin Shah’s head and neck surgery and oncology. 5th ed. New York: Elsevier; 2019.
Cohen EE, Lingen MW, Vokes EE. The expanding role of systemic therapy in head and neck cancer. J Clin Oncol. 2004;22:1743–52.
https://doi.org/10.1200/JCO.2004.06.147 DOI: https://doi.org/10.1200/JCO.2004.06.147
Gibson MK, Li Y, Murphy B, Hussain MHA, DeConti RC, Ensley J, et al. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the eastern cooperative oncology group. J Clin Oncol. 2005;23:3562–7.
https://doi.org/10.1200/JCO.2005.01.057 DOI: https://doi.org/10.1200/JCO.2005.01.057
Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359:1116–27.
https://doi.org/10.1056/NEJMoa0802656 DOI: https://doi.org/10.1056/NEJMoa0802656
Burtness B, Harrington KJ, Greil R, Souliéres D, Tahara M, de Castro G Jr, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019;394:1915–28.
https://doi.org/10.1016/S0140-6736(19)32591-7 DOI: https://doi.org/10.1016/S0140-6736(19)32591-7
Bjørnhart B, Mouritzen MT, Kristiansen C, Schytte T, Wederwang K, Pøhl M, et al. 5-year survival in Danish patients with advanced non-small cell lung cancer treated with immune checkpoint inhibitor monotherapy. Acta Oncol. 2023;62:861–70.
https://doi.org/10.1080/0284186X.2023.2238544 DOI: https://doi.org/10.1080/0284186X.2023.2238544
Søby S, Gothelf A, Gyldenkerne N, Bentzen J, Nowicka-Matus K, Tramm T, et al. Efficacy of nivolumab as second line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a national DAHANCA cohort study. Acta Oncol. 2022;61:972–8.
https://doi.org/10.1080/0284186X.2022.2103387 DOI: https://doi.org/10.1080/0284186X.2022.2103387
Bossi P, Chan AT, Licitra L, Trama A, Orlandi E, Hui EP, et al. Nasopharyngeal carcinoma: ESMO-EURECAN clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32:452–65.
https://doi.org/10.1016/j.annonc.2020.12.007 DOI: https://doi.org/10.1016/j.annonc.2020.12.007
Pitakpaiboonkul P, Jiarpinitnu C, Pattaranutaporn P, Ngamphaiboon N. Early recurrence, time-to-recurrence, and recurrence patterns: assessing their impact on survival outcomes in head and neck squamous cell carcinoma (R/M-HNSCC) patients treated with first line platinum-based chemotherapy. Cancer Med. 2024;13:e7047.
https://doi.org/10.1002/cam4.7047 DOI: https://doi.org/10.1002/cam4.7047
Dai D, Tian Q, Shui Y, Li J, Wei Q. The impact of radiation induced lymphopenia in the prognosis of head and neck cancer: a systematic review and meta-analysis. Radiat Oncol. 2022;168:28–36.
https://doi.org/10.1016/j.radonc.2022.01.003 DOI: https://doi.org/10.1016/j.radonc.2022.01.003
Danish Head and Neck Cancer Group (DAHANCA) [Internet] (no date). [Annual report 2023]. Danish. Available from: https://www.dahanca.dk/CA_Adm_Web_Page?WebPageMenu=3&CA_Web_TabNummer=0.
Lilja-Fischer JK, Kristensen MH, Lassen P, Steiniche T, Tramm T, Stougaard, et al. HPV testing versus p16 immunohistochemistry in oropharyngeal squamous cell carcinoma: results from the DAHANCA 19 study. Acta Oncol. 2023;62:1384–8.
https://doi.org/10.1080/0284186X.2023.2266127 DOI: https://doi.org/10.1080/0284186X.2023.2266127
Published
How to Cite
Issue
Section
Categories
License
Copyright (c) 2025 Bogdana Patachi, Kristian H. Jensen, Anita Gothelf, Mogens Bernsdorf, Jeppe Friborg, Claus A. Kristensen
This work is licensed under a Creative Commons Attribution 4.0 International License.
