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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)
Author(s) -
Yen ChiaJui,
Kiyota Naomi,
Hanai Nobuhiro,
Takahashi Shunji,
Yokota Tomoya,
Iwae Shigemichi,
Shimizu Yasushi,
Hong RueyLong,
Goto Masahiro,
Kang JinHyoung,
Li Wing Sum Kenneth,
Ferris Robert L.,
Gillison Maura,
Endo Toshimitsu,
Jayaprakash Vijayvel,
Tahara Makoto
Publication year - 2020
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.26331
Subject(s) - nivolumab , medicine , oncology , population , clinical trial , refractory (planetary science) , adverse effect , randomized controlled trial , immunotherapy , cancer , environmental health , physics , astrobiology
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.