Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Chia Jui Yen; Naomi Kiyota; Nobuhiro Hanai; Shunji Takahashi; Tomoya Yokota; Shigemichi Iwae; Yasushi Shimizu; Ruey Long Hong; Masahiro Goto; Jin Hyoung Kang; Wing Sum Kenneth Li; Robert L. Ferris; Maura Gillison; Toshimitsu Endo; Vijayvel Jayaprakash; Makoto Tahara

doi:10.1002/hed.26331

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Chia Jui Yen
, Naomi Kiyota
, Nobuhiro Hanai
, Shunji Takahashi
, Tomoya Yokota
, Shigemichi Iwae
, Yasushi Shimizu
, Ruey Long Hong
, Masahiro Goto
, Jin Hyoung Kang
, Wing Sum Kenneth Li
, Robert L. Ferris
, Maura Gillison
, Toshimitsu Endo
, Vijayvel Jayaprakash
, Makoto Tahara

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

32 Scopus citations

Abstract

Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration: NCT02105636.

Original language	English
Pages (from-to)	2852-2862
Number of pages	11
Journal	Head and Neck
Volume	42
Issue number	10
DOIs	https://doi.org/10.1002/hed.26331
State	Published - 1 Oct 2020

Bibliographical note

Publisher Copyright:
© 2020 The Authors. Head & Neck published by Wiley Periodicals LLC.

Keywords

Asian population
clinical trial
immunotherapy
nivolumab
squamous cell carcinoma of the head and neck

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Yen, C. J., Kiyota, N., Hanai, N., Takahashi, S., Yokota, T., Iwae, S., Shimizu, Y., Hong, R. L., Goto, M., Kang, J. H., Li, W. S. K., Ferris, R. L., Gillison, M., Endo, T., Jayaprakash, V., & Tahara, M. (2020). Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141). Head and Neck, 42(10), 2852-2862. https://doi.org/10.1002/hed.26331

@article{fb2d3df794fa41cbbc51af2574fe8ab3,

title = "Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)",

abstract = "Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7\% and 0\% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration: NCT02105636.",

keywords = "Asian population, clinical trial, immunotherapy, nivolumab, squamous cell carcinoma of the head and neck",

author = "Yen, \{Chia Jui\} and Naomi Kiyota and Nobuhiro Hanai and Shunji Takahashi and Tomoya Yokota and Shigemichi Iwae and Yasushi Shimizu and Hong, \{Ruey Long\} and Masahiro Goto and Kang, \{Jin Hyoung\} and Li, \{Wing Sum Kenneth\} and Ferris, \{Robert L.\} and Maura Gillison and Toshimitsu Endo and Vijayvel Jayaprakash and Makoto Tahara",

note = "Publisher Copyright: {\textcopyright} 2020 The Authors. Head \& Neck published by Wiley Periodicals LLC.",

year = "2020",

month = oct,

day = "1",

doi = "10.1002/hed.26331",

language = "English",

volume = "42",

pages = "2852--2862",

journal = "Head and Neck",

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Yen, CJ, Kiyota, N, Hanai, N, Takahashi, S, Yokota, T, Iwae, S, Shimizu, Y, Hong, RL, Goto, M, Kang, JH, Li, WSK, Ferris, RL, Gillison, M, Endo, T, Jayaprakash, V & Tahara, M 2020, 'Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)', Head and Neck, vol. 42, no. 10, pp. 2852-2862. https://doi.org/10.1002/hed.26331

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141). / Yen, Chia Jui; Kiyota, Naomi; Hanai, Nobuhiro et al.
In: Head and Neck, Vol. 42, No. 10, 01.10.2020, p. 2852-2862.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

AU - Yen, Chia Jui

AU - Kiyota, Naomi

AU - Hanai, Nobuhiro

AU - Takahashi, Shunji

AU - Yokota, Tomoya

AU - Iwae, Shigemichi

AU - Shimizu, Yasushi

AU - Hong, Ruey Long

AU - Goto, Masahiro

AU - Kang, Jin Hyoung

AU - Li, Wing Sum Kenneth

AU - Ferris, Robert L.

AU - Gillison, Maura

AU - Endo, Toshimitsu

AU - Jayaprakash, Vijayvel

AU - Tahara, Makoto

PY - 2020/10/1

Y1 - 2020/10/1

N2 - Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration: NCT02105636.

AB - Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial. Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed. Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs. Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. Clinical trial registration: NCT02105636.

KW - Asian population

KW - clinical trial

KW - immunotherapy

KW - nivolumab

KW - squamous cell carcinoma of the head and neck

UR - https://www.scopus.com/pages/publications/85087145277

U2 - 10.1002/hed.26331

DO - 10.1002/hed.26331

M3 - Article

C2 - 32583557

AN - SCOPUS:85087145277

SN - 1043-3074

VL - 42

SP - 2852

EP - 2862

JO - Head and Neck

JF - Head and Neck

IS - 10

ER -

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Abstract

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Keywords

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