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)
Journal
Head and Neck
Journal Volume
42
Journal Issue
10
Pages
2852-2862
Date Issued
2020
Author(s)
Yen C.-J.
Kiyota N.
Hanai N.
Takahashi S.
Yokota T.
Iwae S.
Shimizu Y.
Goto M.
Kang J.-H.
Li W.S.K.
Ferris R.L.
Gillison M.
Endo T.
Jayaprakash V.
Tahara M.
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. ? 2020 The Authors. Head & Neck published by Wiley Periodicals LLC.
Subjects
Asian population; clinical trial; immunotherapy; nivolumab; squamous cell carcinoma of the head and neck
SDGs
Other Subjects
cetuximab; docetaxel; methotrexate; nivolumab; adverse outcome; aged; Article; Asian; cancer patient; cancer recurrence; clinical article; controlled study; decreased appetite; diarrhea; drug choice; drug dose increase; drug dose reduction; drug efficacy; drug safety; endocrine disease; fatigue; female; follow up; gastrointestinal disease; head and neck squamous cell carcinoma; human; hypersensitivity; hypothyroidism; maculopapular rash; male; nausea; open study; overall survival; phase 3 clinical trial; priority journal; pruritus; randomized controlled trial; rash; skin disease; stomatitis; survival rate
Publisher
John Wiley and Sons Inc.
Type
journal article