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Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial

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机构: [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China [2]Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea [3]Department of Head and Neck, Esophageal Medical Oncology and Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan [4]Sarah Cannon Research, London, UK [5]Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain [6]University of Puerto Rico, San Juan, Puerto Rico [7]BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia [8]Harbin Medical University Cancer Hospital, Harbin, China [9]Linyi Cancer Hospital, Linyi, China [10]Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea [11]Henan Cancer Hospital, Zhengzhou, China [12]Vitamed, Moscow, Russia [13]Oncology Department, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China [14]Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea [15]Fourth Hospital of Hebei Medical University, Shijiazhuang, China [16]Hospital, Tokyo, Japan Gastrointestinal Medical Oncology, National Cancer Center [17]Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA [18]Gastroenterological Chemotherapy, Cancer Institute Hospital of JFCR, Tokyo, Japan [19]China Department of Oncology, Taipei Veterans General Hospital, Taipei, [20]Narodowy Instytut Onkologii, Warsaw, Poland [21]Acibadem Adana Hospital, Adana, Turkey [22]Hospital Universitario Miguel Servet, Zaragoza, Spain [23]Azienda Ospedaliero Universitaria Pisana, Pisa, Italy [24]Centre Antoine Lacassagne, Nice, France [25]BeiGene, Boston, MA, USA [26]BeiGene, Shanghai, China [27]BeiGene, Beijing, China [28]Gastrointestinal Oncology, Johannes Gutenberg-University Clinic, Mainz, Germany
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To evaluate the efficacy and safety of tislelizumab added to chemotherapy as first line (primary) treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma compared with placebo plus chemotherapy.Randomised, double blind, placebo controlled, phase 3 study.146 medical centres across Asia, Europe, and North America, between 13 December 2018 and 28 February 2023.1657 patients aged ≥18 years with human epidermal growth factor receptor 2 negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma, regardless of programmed death-ligand 1 (PD-L1) expression status, who had not received systemic anticancer therapy for advanced disease.Patients were randomly (1:1) assigned to receive either tislelizumab 200 mg or placebo intravenously every three weeks in combination with chemotherapy (investigator's choice of oxaliplatin and capecitabine, or cisplatin and 5-fluorouracil) and stratified by region, PD-L1 expression, presence or absence of peritoneal metastases, and investigator's choice of chemotherapy. Treatment continued until disease progression or unacceptable toxicity.The primary endpoint was overall survival, both in patients with a PD-L1 tumour area positivity (TAP) score of ≥5% and in all randomised patients. Safety was assessed in all those who received at least one dose of study treatment.Of 1657 patients screened between 13 December 2018 and 9 February 2021, 660 were ineligible due to not meeting the eligibility criteria, withdrawal of consent, adverse events, or other reasons. Overall, 997 were randomly assigned to receive tislelizumab plus chemotherapy (n=501) or placebo plus chemotherapy (n=496). Tislelizumab plus chemotherapy showed statistically significant improvements in overall survival versus placebo plus chemotherapy in patients with a PD-L1 TAP score of ≥5% (median 17.2 months v 12.6 months; hazard ratio 0.74 (95% confidence interval 0.59 to 0.94); P=0.006 (interim analysis)) and in all randomised patients (median 15.0 months v 12.9 months; hazard ratio 0.80 (0.70 to 0.92); P=0.001 (final analysis)). Grade 3 or worse treatment related adverse events were observed in 54% (268/498) of patients in the tislelizumab plus chemotherapy arm versus 50% (246/494) in the placebo plus chemotherapy arm.Tislelizumab added to chemotherapy as primary treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma provided superior overall survival with a manageable safety profile versus placebo plus chemotherapy in patients with a PD-L1 TAP score of ≥5%, and in all randomised patients.ClinicalTrials.gov NCT03777657.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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大类 | 1 区 医学
小类 | 1 区 医学:内科
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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medical Sciences, Guangzhou, China
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