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Pembrolizumab in Asia-Pacific patients with advanced head and neck squamous cell carcinoma: Analyses from KEYNOTE-012

 Makoto Tahara  ;  Kei Muro  ;  Yasuhisa Hasegawa  ;  Hyun Cheol Chung  ;  Chia-Chi Lin  ;  Bhumsuk Keam  ;  Kenichi Takahashi  ;  Jonathan D Cheng  ;  Yung-Jue Bang 
 CANCER SCIENCE, Vol.109(3) : 771-776, 2018 
Journal Title
Issue Date
Monoclonal Antibodies, Humanized/*administration & dosage/therapeutic use ; Immunological/*administration & dosage/therapeutic use Antineoplastic Agents ; Asia ; Squamous Cell/*drug therapy Carcinoma ; Cohort Studies ; Drug Administration Schedule ; Female ; Head and Neck Neoplasms/*drug therapy ; Humans ; Male ; Survival Analysis ; Treatment Outcome
Asia-Pacific ; PD-1 ; PD-L1 ; Pembrolizumab ; head and neck squamous cell carcinoma
KEYNOTE-012 was a phase Ib, multicohort study designed to investigate efficacy and safety of pembrolizumab in advanced solid tumors. Results from the subset of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the Asia-Pacific region are reported. Patients with recurrent/metastatic HNSCC, measurable disease (RECIST version 1.1), and ECOG performance status (PS) 0-1 were eligible for enrollment in the HNSCC expansion cohort. Patients received pembrolizumab 200 mg every 3 weeks. Response was assessed every 8 weeks. Co-primary end-points were safety and overall response rate (RECIST version 1.1, central review). Secondary end-points included overall survival and response duration. Patients enrolled at any of the five centers throughout the Asia-Pacific region were included in these analyses. Twenty-six patients with HNSCC from the Asia-Pacific region received pembrolizumab. The median age was 62 years, 65% of patients had ECOG PS 1, and 62% had received two or more prior therapies for recurrent/metastatic disease. Sixteen (62%) patients experienced a treatment-related adverse event of any grade, including two (8%) patients who experienced one or more events of grade 3 severity. No treatment-related deaths occurred. The overall response rate was 19% (95% confidence interval, 7%-39%). After a median follow-up of 12 months (range, 2-21 months), a median response duration was not reached (range, 6 to 17+ months); four of five responses lasted >/=6 months. Median overall survival was 11.6 months (95% confidence interval, 4.7-17.7 months). Pembrolizumab was well tolerated and had durable antitumor activity in patients with HNSCC from the Asia-Pacific region. (Trial registration no. NCT01848834.).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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