{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Evrard C"],"funding":["AstraZeneca (France)","FFCD","Fédération Francophone de Cancérologie Digestive (FFCD)","Astra Zeneca","Fédération Francophone de Cancérologie Digestive"],"pagination":["1211"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9138589"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["10(5)"],"pubmed_abstract":["Efficacy of immune checkpoint inhibitors (ICI) as monotherapy in 2nd line treatment for gastric or gastro-oesophageal junction (GEJ) adenocarcinoma is low, with no evaluation of efficacy and safety of ICI combined with chemotherapy. The DURIGAST PRODIGE 59 study is a randomised, multicentre, phase II study designed to assess the efficacy and safety of the combination of FOLFIRI + Durvalumab +/- Tremelimumab as 2nd line treatment of patients with advanced gastric/GEJ adenocarcinoma. Here, we report data from the safety run-in phase with FOLFIRI Durvalumab (arm A) or FOLFIRI Durvalumab and Tremelimumab (arm B). Among the 11 patients included, 63.6% experienced at least one grade 3-4 adverse events (AEs) related to the treatment, most frequently neutropenia (36.4%). There was only one immune-"],"journal":["Biomedicines"],"pubmed_title":["Safety of FOLFIRI + Durvalumab +/- Tremelimumab in Second Line of Patients with Advanced Gastric Cancer: A Safety Run-In from the Randomized Phase II Study DURIGAST PRODIGE 59."],"pmcid":["PMC9138589"],"funding_grant_id":["none"],"pubmed_authors":["Evrard C","Soularue E","Desrame J","On Behalf Of The Durigast-Prodige Investigators/Collaborators","Gonzalez D","Le Malicot K","Tougeron D","Aparicio T","Bouche O","Botsen D","El Hajbi F","Lepage C"],"additional_accession":[]},"is_claimable":false,"name":"Safety of FOLFIRI + Durvalumab +/- Tremelimumab in Second Line of Patients with Advanced Gastric Cancer: A Safety Run-In from the Randomized Phase II Study DURIGAST PRODIGE 59.","description":"Efficacy of immune checkpoint inhibitors (ICI) as monotherapy in 2nd line treatment for gastric or gastro-oesophageal junction (GEJ) adenocarcinoma is low, with no evaluation of efficacy and safety of ICI combined with chemotherapy. The DURIGAST PRODIGE 59 study is a randomised, multicentre, phase II study designed to assess the efficacy and safety of the combination of FOLFIRI + Durvalumab +/- Tremelimumab as 2nd line treatment of patients with advanced gastric/GEJ adenocarcinoma. Here, we report data from the safety run-in phase with FOLFIRI Durvalumab (arm A) or FOLFIRI Durvalumab and Tremelimumab (arm B). Among the 11 patients included, 63.6% experienced at least one grade 3-4 adverse events (AEs) related to the treatment, most frequently neutropenia (36.4%). There was only one immune-","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 May","modification":"2026-06-21T03:14:15.647Z","creation":"2024-11-15T16:23:37.563Z"},"accession":"S-EPMC9138589","cross_references":{"pubmed":["35625947"],"doi":["10.3390/biomedicines10051211"]}}