11/10/2023 0 Comments KeynotepcPembrolizumab plus chemotherapy was superior to placebo plus chemotherapy for progression-free survival in patients with oesophageal squamous cell carcinoma (6♳ months vs 5♸ months 0♶5 p<0♰001), PD-L1 CPS of 10 or more (7♵ months vs 5♵ months 0♵1 p<0♰001), and in all randomised patients (6♳ months vs 5♸ months 0♶5 p<0♰001). At the first interim analysis (median follow-up of 22♶ months), pembrolizumab plus chemotherapy was superior to placebo plus chemotherapy for overall survival in patients with oesophageal squamous cell carcinoma and PD-L1 CPS of 10 or more (median 13♹ months vs 8♸ months hazard ratio 0♵7 p<0♰001), oesophageal squamous cell carcinoma (12♶ months vs 9♸ months 0♷2 p=0♰006), PD-L1 CPS of 10 or more (13♵ months vs 9♴ months 0♶2 p<0♰001), and in all randomised patients (12♴ months vs 9♸ months 0♷3 p<0♰001). This trial is registered with, NCT03189719, and is closed to recruitment.īetween July 25, 2017, and June 3, 2019, 1020 patients were screened and 749 were enrolled and randomly assigned to pembrolizumab plus chemotherapy (n=373 ) or placebo plus chemotherapy (n=376 ). Primary endpoints were overall survival in patients with oesophageal squamous cell carcinoma and PD-L1 combined positive score (CPS) of 10 or more, and overall survival and progression-free survival in patients with oesophageal squamous cell carcinoma, PD-L1 CPS of 10 or more, and in all randomised patients. Patients, investigators, and site staff were masked to group assignment and PD-L1 biomarker status. ![]() Randomisation was stratified by geographical region, histology, and performance status. Patients aged 18 years or older with previously untreated, histologically or cytologically confirmed, locally advanced, unresectable or metastatic oesophageal cancer or Siewert type 1 gastro-oesophageal junction cancer (regardless of PD-L1 status), measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1, and Eastern Cooperative Oncology Group performance status of 0-1, were randomly assigned (1:1) to intravenous pembrolizumab 200 mg or placebo, plus 5-fluorouracil and cisplatin (chemotherapy), once every 3 weeks for up to 35 cycles. We did a randomised, placebo-controlled, double-blind, phase 3 study across 168 medical centres in 26 countries. We aimed to evaluate the antitumour activity of pembrolizumab plus chemotherapy versus chemotherapy alone as first-line treatment in advanced oesophageal cancer and Siewert type 1 gastro-oesophageal junction cancer. 22 National Cancer Center Hospital, Tokyo, Japan.įirst-line therapy for advanced oesophageal cancer is currently limited to fluoropyrimidine plus platinum-based chemotherapy.20 Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.19 Kagawa University Hospital, Kagawa, Japan.18 Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.17 University Hospital of Santa Maria, Federal University of Santa Maria, and Viver Research Center, Santa Maria, Brazil.16 Saitama Cancer Center, Saitama, Japan. ![]() 15 Hematology Oncology Practice Eppendorf and University Cancer Center Hamburg, Hamburg, Germany.14 Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.13 Prince of Songkla University Hospital, Songkhla, Thailand.12 Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.11 Christie Hospital NHS Trust, Manchester, UK.10 Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.9 Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. ![]() 8 Section of Oesophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.7 CHU Brest-Institut de Cancerologie et d'Hematologie ARPEGO Network, Brest, France.6 National Cancer Center Hospital East, Kashiwa, Japan.5 Institut de Recherche en Cancérologie de Montpellier (IRCM), Inserm, Université Montpellier, ICM, Montpellier, France.4 Dana Farber Cancer Institute, Boston, MA, USA.3 Weill Cornell Medical College, New York City, NY, USA.Electronic address: 2 Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China. 1 Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.
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