@article{3c711d74b6bc44799188dc8c0689e05a,
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.",
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 = "Funding Information: The authors thank all of the patients who participated in this study and their families as well as all the investigators, physicians, nurses, and clinical research coordinators who helped with this study. We also acknowledge the statistical support of Shunsuke Hagihara (ONO Pharmaceutical) and Yuka Ono (CAC Croit Corporation). This work was supported by ONO Pharmaceutical and Bristol-Myers Squibb. Funding Information: The authors thank all of the patients who participated in this study and their families as well as all the investigators, physicians, nurses, and clinical research coordinators who helped with this study. We also acknowledge the statistical support of Shunsuke Hagihara (ONO Pharmaceutical) and Yuka Ono (CAC Croit Corporation). This work was supported by ONO Pharmaceutical and Bristol‐Myers Squibb. 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",
issn = "1043-3074",
publisher = "John Wiley and Sons Inc.",
number = "10",
}