論文

査読有り 国際誌
2020年6月24日

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 & neck
  • 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

記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1002/hed.26331

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.

リンク情報
DOI
https://doi.org/10.1002/hed.26331
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/32583557

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