Real-world evaluation of nivolumab in patients with non-nasopharyngeal recurrent or metastatic head and neck cancer: a retrospective multi-center study by the Turkish Oncology Group (TOG).
Head and neck cancer
Nivolumab
Journal
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
ISSN: 1434-4726
Titre abrégé: Eur Arch Otorhinolaryngol
Pays: Germany
ID NLM: 9002937
Informations de publication
Date de publication:
25 May 2024
25 May 2024
Historique:
received:
13
11
2023
accepted:
16
05
2024
medline:
25
5
2024
pubmed:
25
5
2024
entrez:
25
5
2024
Statut:
aheadofprint
Résumé
Head and neck cancers (HNCs) represent a significant global health concern due to high morbidity and mortality rates. Despite therapeutic advances, the prognosis for advanced or recurrent cases remains challenging. Nivolumab obtained approval for recurrent or metastatic HNC based on the Phase III CheckMate 141 trial. This study aimed to evaluate the real-world outcomes of nivolumab in patients with non-nasopharyngeal HNC. In this multicenter retrospective study, we analyzed 124 patients with recurrent or metastatic non-nasopharyngeal HNC who received nivolumab in the second-line setting and beyond. Data were collected from 20 different cancer centers across Turkey. The effectiveness and safety of the treatment and survival outcomes were evaluated. Nivolumab exhibited favorable clinical responses, yielding an objective response rate of 29.9% and a disease control rate of 55.7%. Safety assessments revealed a generally well-tolerated profile, with no instances of treatment discontinuation or mortality due to side effects. Survival analysis disclosed a median overall survival (OS) of 11.8 (95% CI 8.4-15.2) months. Multivariate analysis revealed that ECOG-PS ≥ 1 (HR: 1.64, p = 0.045), laryngeal location (HR: 0.531, p = 0.024), and neutrophil-to-lymphocyte ratio > 3.5 (HR: 1.97, p = 0.007) were independent predictors of OS. Nivolumab is an effective and safe treatment option for patients with recurrent or metastatic non-nasopharyngeal HNC in real-world settings. Further studies are needed on factors affecting response to treatment and survival outcomes.
Identifiants
pubmed: 38795147
doi: 10.1007/s00405-024-08744-4
pii: 10.1007/s00405-024-08744-4
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A (2018) Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 68(6):394–424
doi: 10.3322/caac.21492
pubmed: 30207593
Fitzmaurice C, Allen C, Barber RM et al (2017) Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: a systematic analysis for the Global Burden of Disease Study. JAMA Oncol 3(4):524–548
doi: 10.1001/jamaoncol.2016.5688
pubmed: 27918777
Siegel RL, Miller KD, Jemal A (2018) Cancer statistics. CA Cancer J Clin 68(1):7–30
doi: 10.3322/caac.21442
pubmed: 29313949
Chow LQM (2020) Head and Neck Cancer. N Engl J Med 382(1):60–72
doi: 10.1056/NEJMra1715715
pubmed: 31893516
Vermorken JB, Specenier P (2010) Optimal treatment for recurrent/metastatic head and neck cancer. Ann Oncol 21(Suppl 7):vii252–vii261
doi: 10.1093/annonc/mdq453
pubmed: 20943624
Marur S, Forastiere AA (2008) Head and neck cancer: changing epidemiology, diagnosis, and treatment. Mayo Clin Proc 83(4):489–501
doi: 10.4065/83.4.489
pubmed: 18380996
Pisani P, Airoldi M, Allais A et al (2020) Metastatic disease in head & neck oncology. Acta Otorhinolaryngol Ital 40(Suppl. 1):S1-s86
doi: 10.14639/0392-100X-suppl.1-40-2020
pubmed: 32469009
pmcid: 7263073
Ferris RL, Blumenschein G, Fayette J et al (2016) Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med 375(19):1856–1867
doi: 10.1056/NEJMoa1602252
pubmed: 27718784
pmcid: 5564292
Cohen EEW, Bell RB, Bifulco CB et al (2019) The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC). J Immunother Cancer 7(1):184
doi: 10.1186/s40425-019-0662-5
pubmed: 31307547
pmcid: 6632213
Yasumatsu R, Shimizu Y, Hanai N et al (2022) Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study. Int J Clin Oncol 27(1):95–104
doi: 10.1007/s10147-021-02047-y
pubmed: 34773525
Vasiliadou I, Breik O, Baker H et al (2021) Safety and treatment outcomes of nivolumab for the treatment of recurrent or metastatic head and neck squamous cell carcinoma: retrospective multicenter cohort study. Cancers (Basel) 13(6):1413
doi: 10.3390/cancers13061413
pubmed: 33808781
Matsuki T, Okamoto I, Fushimi C et al (2020) Real-world, long-term outcomes of nivolumab therapy for recurrent or metastatic squamous cell carcinoma of the head and neck and impact of the magnitude of best overall response: a retrospective multicenter study of 88 patients. Cancers (Basel) 12(11):3427
doi: 10.3390/cancers12113427
pubmed: 33218183
Wagner SM, Magnes T, Melchardt T et al (2023) Real-world data of palliative first-line checkpoint inhibitor therapy for head and neck cancer. Anticancer Res 43(3):1273–1282
doi: 10.21873/anticanres.16274
pubmed: 36854497
Gogate A, Bennett B, Poonja Z et al (2023) Phase 4 multinational multicenter retrospective and prospective real-world study of nivolumab in recurrent and metastatic squamous cell carcinoma of the head and neck. Cancers (Basel) 15(14):3552
doi: 10.3390/cancers15143552
pubmed: 37509217
Kariya S, Shimizu Y, Hanai N et al (2021) Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting. Int J Clin Oncol 26(6):1049–1056
doi: 10.1007/s10147-021-01900-4
pubmed: 33830342
pmcid: 8134300
Serindere G, Bolgul B, Gursoy D, Hakverdi S, Savas N (2019) Comparison of head and neck cancer distribution in Turkish and Syrian populations. Iran J Public Health 48(10):1810–1816
pubmed: 31850258
pmcid: 6908918
Guo K, Xiao W, Chen X, Zhao Z, Lin Y, Chen G (2021) Epidemiological trends of head and neck cancer: a population-based study. Biomed Res Int 2021:1738932
pubmed: 34337000
pmcid: 8294963
Ferris RL, Blumenschein G, Fayette J et al (2018) Nivolumab vs investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression. Oral Oncol 81:45–51
doi: 10.1016/j.oraloncology.2018.04.008
pubmed: 29884413
pmcid: 6563923
Okamoto I, Sato H, Kondo T et al (2019) Efficacy and safety of nivolumab in 100 patients with recurrent or metastatic head and neck cancer - a retrospective multicentre study. Acta Otolaryngol 139(10):918–925
doi: 10.1080/00016489.2019.1648867
pubmed: 31460818
Matsuo M, Yasumatsu R, Masuda M et al (2020) Relationship between immune-related adverse events and the long-term outcomes in recurrent/metastatic head and neck squamous cell carcinoma treated with nivolumab. Oral Oncol 101:104525
doi: 10.1016/j.oraloncology.2019.104525
pubmed: 31863963
Hori R, Shinohara S, Kojima T et al (2019) Real-world outcomes and prognostic factors in patients receiving nivolumab therapy for recurrent or metastatic head and neck carcinoma. Cancers (Basel) 11(9):1317
doi: 10.3390/cancers11091317
pubmed: 31500103
Otsuki S, Hori R, Shinohara S et al (2022) Real-world 2-year long-term outcomes and prognostic factors in patients receiving nivolumab therapy for recurrent or metastatic squamous cell carcinoma of the head and neck. Auris Nasus Larynx 49(5):834–844
doi: 10.1016/j.anl.2022.02.006
pubmed: 35232636
Kim H, Kwon M, Kim B et al (2020) Clinical outcomes of immune checkpoint inhibitors for patients with recurrent or metastatic head and neck cancer: real-world data in Korea. BMC Cancer 20(1):727
doi: 10.1186/s12885-020-07214-4
pubmed: 32758163
pmcid: 7405432
Vallianou NG, Evangelopoulos A, Kounatidis D et al (2023) Immunotherapy in head and neck cancer: where do we stand? Curr Oncol Rep 25(8):897–912
doi: 10.1007/s11912-023-01425-1
pubmed: 37213060
Hwang M, Canzoniero JV, Rosner S et al (2022) Peripheral blood immune cell dynamics reflect antitumor immune responses and predict clinical response to immunotherapy. J Immunother Cancer 10(6):e004688
doi: 10.1136/jitc-2022-004688
pubmed: 35688557
pmcid: 9189831
Valero C, Lee M, Hoen D et al (2021) Pretreatment neutrophil-to-lymphocyte ratio and mutational burden as biomarkers of tumor response to immune checkpoint inhibitors. Nat Commun 12(1):729
doi: 10.1038/s41467-021-20935-9
pubmed: 33526794
pmcid: 7851155
Cao D, Xu H, Xu X, Guo T, Ge W (2018) A reliable and feasible way to predict the benefits of Nivolumab in patients with non-small cell lung cancer: a pooled analysis of 14 retrospective studies. Oncoimmunology 7(11):e1507262
doi: 10.1080/2162402X.2018.1507262
pubmed: 30377569
pmcid: 6205035
Nakaya A, Kurata T, Yoshioka H et al (2018) Neutrophil-to-lymphocyte ratio as an early marker of outcomes in patients with advanced non-small-cell lung cancer treated with nivolumab. Int J Clin Oncol 23(4):634–640
doi: 10.1007/s10147-018-1250-2
pubmed: 29442281
pmcid: 6097082