論文

査読有り 国際誌
2018年7月

Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012.

British journal of cancer
  • Ranee Mehra
  • ,
  • Tanguy Y Seiwert
  • ,
  • Shilpa Gupta
  • ,
  • Jared Weiss
  • ,
  • Iris Gluck
  • ,
  • Joseph P Eder
  • ,
  • Barbara Burtness
  • ,
  • Makoto Tahara
  • ,
  • Bhumsuk Keam
  • ,
  • Hyunseok Kang
  • ,
  • Kei Muro
  • ,
  • Ravit Geva
  • ,
  • Hyun Cheol Chung
  • ,
  • Chia-Chi Lin
  • ,
  • Deepti Aurora-Garg
  • ,
  • Archana Ray
  • ,
  • Kumudu Pathiraja
  • ,
  • Jonathan Cheng
  • ,
  • Laura Q M Chow
  • ,
  • Robert Haddad

119
2
開始ページ
153
終了ページ
159
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1038/s41416-018-0131-9

BACKGROUND: Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up. METHODS: Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review). RESULTS: Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%. CONCLUSIONS: Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.

リンク情報
DOI
https://doi.org/10.1038/s41416-018-0131-9
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29955135
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6048158

エクスポート
BibTeX RIS