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
Camille Evrard,
Thomas Aparicio,
Emilie Soularue,
Karine Le Malicot,
Jérôme Desramé,
Damien Botsen,
Farid El Hajbi,
Daniel Gonzalez,
Come Lepage,
Olivier Bouché,
David Tougeron,
on behalf of the DURIGAST—PRODIGE 59 Investigators/Collaborators
Affiliations
Camille Evrard
Service d’Oncologie Médicale, Centre Hospitalo-Universitaire de Poitiers, 86000 Poitiers, France
Thomas Aparicio
Service d’Hépato Gastro-Entérologie et de Cancérologie Digestive, Hôpital Saint Louis, 75010 Paris, France
Emilie Soularue
Service d’Oncologie Médicale, Institute Mutualiste Montsouris, 75014 Paris, France
Karine Le Malicot
Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Université de Bourgogne Franche-Comté, 21000 Dijon, France
Jérôme Desramé
Institut de Cancérologie, Hôpital Privé Jean Mermoz, 69008 Lyon, France
Damien Botsen
Service d’Hépato Gastro-Entérologie et de Cancérologie Digestive, Hôpital Universitaire de Reims, 51100 Reims, France
Farid El Hajbi
Service d’Hépato Gastro-Entérologie et de Cancérologie Digestive, Centre Oscar Lambret, 59000 Lille, France
Daniel Gonzalez
Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Université de Bourgogne Franche-Comté, 21000 Dijon, France
Come Lepage
Fédération Francophone de Cancérologie Digestive, EPICAD INSERM LNC-UMR 1231, Université de Bourgogne Franche-Comté, 21000 Dijon, France
Olivier Bouché
Service d’Hépato Gastro-Entérologie et de Cancérologie Digestive, Hôpital Universitaire de Reims, 51100 Reims, France
David Tougeron
Service d’Hépato Gastro-Entérologie, Hôpital Universitaire de Poitiers, 86000 Poitiers, France
on behalf of the DURIGAST—PRODIGE 59 Investigators/Collaborators
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-related AE (grade 2 hyperthyroidism). Ten serious AEs were described among six patients, but only two were related to the treatment, due to the chemotherapy. One seizure epilepsy related to a brain metastasis was observed, but was not related by the investigator to the treatment. However, the Independent Data Monitoring Committee recommended brain imaging at inclusion. This safety run-in phase demonstrates an expected safety profile of FOLFIRI with Durvalumab +/− Tremelimumab combination allowing the randomised phase II.
