論文

査読有り 国際誌
2018年6月

Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.

Oral oncology
  • Robert L Ferris
  • ,
  • George Blumenschein Jr
  • ,
  • Jerome Fayette
  • ,
  • Joel Guigay
  • ,
  • A Dimitrios Colevas
  • ,
  • Lisa Licitra
  • ,
  • Kevin J Harrington
  • ,
  • Stefan Kasper
  • ,
  • Everett E Vokes
  • ,
  • Caroline Even
  • ,
  • Francis Worden
  • ,
  • Nabil F Saba
  • ,
  • Lara Carmen Iglesias Docampo
  • ,
  • Robert Haddad
  • ,
  • Tamara Rordorf
  • ,
  • Naomi Kiyota
  • ,
  • Makoto Tahara
  • ,
  • Mark Lynch
  • ,
  • Vijayvel Jayaprakash
  • ,
  • Li Li
  • ,
  • Maura L Gillison

81
開始ページ
45
終了ページ
51
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/j.oraloncology.2018.04.008

OBJECTIVES: We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN). METHODS: Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017. RESULTS: With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and  < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively. CONCLUSION: Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).

Web of Science ® 被引用回数 : 130

リンク情報
DOI
https://doi.org/10.1016/j.oraloncology.2018.04.008
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29884413
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6563923
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000434682200007&DestApp=WOS_CPL

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