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Multicenter Study
. 2024 Sep;281(9):4991-4999.
doi: 10.1007/s00405-024-08744-4. Epub 2024 May 25.

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)

Arif Akyildiz  1 , Deniz Can Guven  2 , Baris Koksal  2 , Beliz Bahar Karaoglan  3 , Derya Kivrak  4 , Rashad Ismayilov  5 , Firat Aslan  6 , Osman Sutcuoglu  7 , Ozan Yazici  7 , Ahmet Kadioglu  8 , Ozkan Alan  9 , Nargiz Majidova  10 , Mert Erciyestepe  11 , Erkan Ozcan  12 , Goncagul Akdag  13 , Hakan Taban  14 , Ali Osman Kaya  15 , Murad Guliyev  16 , Nilgun Yildirim  17 , Teoman Sakalar  18 , Dogan Yazilitas  19 , Caglar Unal  20 , Sercan On  21 , Sedat Biter  22 , Nebi Serkan Demirci  16 , Filiz Cay Senler  3 , Yasemin Kemal  23 , Omer Diker Halil  24 , Ibrahim Gullu  2 , Sercan Aksoy  2
Affiliations
Multicenter Study

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)

Arif Akyildiz et al. Eur Arch Otorhinolaryngol. 2024 Sep.

Abstract

Objectives: 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.

Design: 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.

Results: 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.

Conclusions: 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.

Keywords: Head and neck cancer; Nivolumab.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Comparison of PD-L1 negative and positive patients according to the presence of overall response (a) and disease control (b)
Fig. 2
Fig. 2
Overall survival (a) and progression-free survival (b)—Kaplan Meier curves
Fig. 3
Fig. 3
Associations between ECOG-PS (a), primary tumor location (b), NLR (c), and p16 positivity (d) with overall survival—Kaplan–Meier curves
See this image and copyright information in PMC

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