Artikel ; Online: 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.
2024 Band 385, Seite(n) e078876
Abstract: Objective: 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.: Design: Randomised, ... ...
Abstract | Objective: 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. Design: Randomised, double blind, placebo controlled, phase 3 study. Setting: 146 medical centres across Asia, Europe, and North America, between 13 December 2018 and 28 February 2023. Participants: 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. Interventions: 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. Main outcome measures: 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. Results: 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 Conclusions: 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. Trial registration: ClinicalTrials.gov NCT03777657. |
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Mesh-Begriff(e) | Humans ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/therapeutic use ; Male ; Stomach Neoplasms/drug therapy ; Stomach Neoplasms/pathology ; Adenocarcinoma/drug therapy ; Adenocarcinoma/pathology ; Adenocarcinoma/mortality ; Female ; Middle Aged ; Double-Blind Method ; Esophageal Neoplasms/drug therapy ; Esophageal Neoplasms/pathology ; Esophageal Neoplasms/mortality ; Esophagogastric Junction/pathology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Aged ; Adult ; Cisplatin/administration & dosage ; Cisplatin/therapeutic use ; Capecitabine/administration & dosage ; Capecitabine/therapeutic use ; Fluorouracil/administration & dosage ; Fluorouracil/therapeutic use |
Chemische Substanzen | Antibodies, Monoclonal, Humanized ; tislelizumab (0KVO411B3N) ; Cisplatin (Q20Q21Q62J) ; Capecitabine (6804DJ8Z9U) ; Fluorouracil (U3P01618RT) |
Sprache | Englisch |
Erscheinungsdatum | 2024-05-28 |
Erscheinungsland | England |
Dokumenttyp | Journal Article ; Randomized Controlled Trial ; Clinical Trial, Phase III ; Multicenter Study ; Research Support, Non-U.S. Gov't |
ZDB-ID | 1362901-3 |
ISSN | 1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151 |
ISSN (online) | 1756-1833 |
ISSN | 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151 |
DOI | 10.1136/bmj-2023-078876 |
Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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