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

 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 
 British Journal of Cancer, Vol.119(2) : 153-159, 2018 
Journal Title
 British Journal of Cancer 
Issue Date
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
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정현철(Chung, Hyun Cheol) ORCID logo https://orcid.org/0000-0002-0920-9471
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