دورية أكاديمية
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.
| العنوان: | Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. |
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| المؤلفون: | Burtness, Barbara, Harrington, Kevin J, Greil, Richard, Soulières, Denis, Tahara, Makoto, de Castro, Gilberto, Psyrri, Amanda, Basté, Neus, Neupane, Prakash, Bratland, Ã…se, Fuereder, Thorsten, Hughes, Brett G M, MesÃa, Ricard, Ngamphaiboon, Nuttapong, Rordorf, Tamara, Wan Ishak, Wan Zamaniah, Hong, Ruey-Long, González Mendoza, René, Roy, Ananya, Zhang, Yayan, Gumuscu, Burak, Cheng, Jonathan D, Jin, Fan, Rischin, Danny, Patson, Brian J., MD |
| المصدر: | Department of Medicine |
| بيانات النشر: | LVHN Scholarly Works |
| سنة النشر: | 2019 |
| المجموعة: | Lehigh Valley Health Network: LVHN Scholarly Works |
| مصطلحات موضوعية: | Aged, Antibodies, Monoclonal, Humanized, Antimetabolites, Antineoplastic, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Cetuximab, Female, Fluorouracil, Head and Neck Neoplasms, Humans, Male, Middle Aged, Progression-Free Survival, Squamous Cell Carcinoma of Head and Neck, Department of Medicine, Medicine and Health Sciences |
| الوصف: | BACKGROUND: Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. METHODS: KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This ... |
| نوع الوثيقة: | text |
| اللغة: | unknown |
| العلاقة: | https://scholarlyworks.lvhn.org/medicine/6231Test; https://pubmed.ncbi.nlm.nih.gov/31679945Test/ |
| الإتاحة: | https://scholarlyworks.lvhn.org/medicine/6231Test https://pubmed.ncbi.nlm.nih.gov/31679945Test/ |
| رقم الانضمام: | edsbas.BA5C1583 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |