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Efficacy of Nivolumab for Head and Neck Cancer Patients with Primary Sites and Histological Subtypes Excluded from the CheckMate-141 Trial

Authors Sato Y, Fukuda N, Wang X, Urasaki T, Ohmoto A, Nakano K, Yunokawa M, Ono M, Sato Y, Mitani H, Tomomatsu J, Takahashi S

Received 11 February 2020

Accepted for publication 12 May 2020

Published 3 June 2020 Volume 2020:12 Pages 4161—4168


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4

Editor who approved publication: Professor Rudolph Navari

Yasuyoshi Sato,1 Naoki Fukuda,1 Xiaofei Wang,1 Tetsuya Urasaki,1 Akihiro Ohmoto,1 Kenji Nakano,1 Mayu Yunokawa,1 Makiko Ono,1 Yukiko Sato,2 Hiroki Mitani,3 Junichi Tomomatsu,1 Shunji Takahashi1

1Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan; 2Pathology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan; 3Head and Neck Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo 135-8550, Japan

Correspondence: Junichi Tomomatsu
Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-Ku, Tokyo 135-8550, Japan
Tel +8135200111
Fax +81335200141

Background: In the CheckMate-141 trial, nivolumab conferred a survival benefit in patients with recurrent or metastatic refractory squamous cell carcinoma (SCC) head and neck cancer (HNC). Here, we examined the efficacy of nivolumab in patients with histological subtypes or primary sites of HNC not included in the CheckMate-141 trial.
Methods: This was a retrospective analysis of data collected prospectively from 97 patients who were treated with nivolumab for recurrent or metastatic HNC at our institution. The patients were assigned to three groups based on HNC primary site: 1) oral cavity, pharynx, and larynx, which were included in CheckMate-141 (n = 68), 2) nasopharynx (excluded in CheckMate-141, n = 7) and 3) other primary sites excluded in CheckMate-141 (n = 22) and assigned to two groups according to histological subtype: 1) SCC (included in CheckMate-141, n = 83) and 2) non-SCC (all sites excluded in CheckMate-141, n = 14). Survival outcomes and nivolumab treatment response were compared between the primary site and histological subgroups.
Results: The median number of nivolumab treatments was 7 cycles (range, 1– 53 cycles) and the median follow-up time was 9.1 months (range, 0.66– 33.0 months). There were no significant differences in response rates between the three primary site subgroups (CheckMate-141 sites 22%, nasopharynx 43%, others 18%; p=0) or the two histological subtype subgroups (SCC 25%, non-SCC  7%, p=0). Similarly, overall survival and progression-free survival were comparable for patients stratified by primary site or histological subtype.
Conclusion: No significant difference in response rates or survival outcomes was detected between nivolumab-treated HNC patients with primary sites and histological subtypes that were included versus excluded in the CheckMate-141 trial. These data provide a potential rationale for nivolumab therapy for all HNC patients in clinical practice.

Keywords: head and neck cancer, nivolumab, PD-1, immunotherapy, immune checkpoint inhibitor, CheckMate-141

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