Trifluridine/tipiracil + oxaliplatin ± nivolumab vs FOLFOX ± nivolumab in HER2 negative advanced oesogastric adenocarcinoma: The PRODIGE73-UCGI40-LOGICAN trial.

Meher Ben Abdelghani, Pierre Decazes, Nicolas De Sousa Carvalho, Emilie Oularue, Pierre-Guillaume Poureau, Bruno Huguenin, Clémence Toullec, Jonathan Olesinski, Véronique Jestin-Le-Tallec, Christelle De La Fouchardiere, Thomas Aparicio, David Tougeron, Ludovic Evesque, Hervé Devaud, Christophe Borg, Damien Botsen, Frédéric Di Fiore, Hanifa Ammarguellat, Olivier Bouche, Aziz Zaanan, Olivier Dubreuil, Hervé Perrier, Sylvie Chabaud, Marie Muller, Samy Ammari, Clélia Coutzac

Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2024;56(8):1281-1287

PMID: 38762353

Free Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND

Trifluridine/tipiracil (FTD/TPI) is approved in third-line treatment of patients with advanced/metastatic gastric and gastroesophageal junction adenocarcinomas (aGA/GEJA). The association of oxaliplatin with FTD/TPI is promising and the combination of FTD/TPI + oxaliplatin + nivolumab has shown a predictable and manageable safety profile.

AIMS

The aim is to evaluate the efficacy and safety of FTD/TPI plus oxaliplatin with or without nivolumab in patients, with HER2 negative aGA/GEJA, unfit for triplet chemotherapy (TFOX/mFLOT regimen), in the first-line metastatic setting in comparison with the standard of care FOLFOX with or without nivolumab.

METHODS

This study is a prospective randomised, open label, comparative, multicentre, phase II trial designed to include 118 patients. The primary objective is to evaluate the superiority of FTD/TPI plus oxaliplatin with or without nivolumab over FOLFOX regimen with or without nivolumab in terms of PFS in a population of patients non candidate for triplet chemotherapy. Nivolumab will be used for patients whose tumour express PD-L1 with a CPS score ≥5.

DISCUSSION

PRODIGE73-UCGI40-LOGICAN study will provide efficacy and safety data on the association of FTD/TPI plus oxaliplatin with or without nivolumab versus FOLFOX regimen with or without nivolumab in first-line palliative setting, in patients with aGA/GEJA (NCT05476796).

Address: Medical Oncology Department, Godinot Cancer Institute, 1 avenue General Koenig, Reims 51100, France.; Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.; Medical Oncology Department, Saint-Joseph Hospital, Marseille, France.; Medical Oncology Department, Beauvais Hospital, Beauvais, France.; Clinique Pasteur Lanroze, Brest, France.; Gastroenterology Department, Villefranche Sur Saone North West Hospital, Gleize, France.; Medical Oncology Department, Sainte Catherine Institute, Avignon, France.; Gastroenterology Department, Saint Louis Hospital, Paris, France.; Medical Oncology Department, ICANS, Strasbourg, France.; Medical Oncology Department, Hopital Nord Franche Comté, Montbeliard France.; Hepato-Gastroenterology and Digestive Oncology Department, CHU, Reims, France.; Medical Oncology Department, Centre Léon Bérard, Lyon France.; Medical Oncology Department, Centre Jean Perrin, Clermont Ferrand, France.; Hepato-Gastroenterology Department, Charles Nicolles Hospital, Rouen, France.; Oncology Department, GH Diaconesses - Croix St Simon, Paris, France.; Medical Oncology Department, Centre Antoine Lacassagne, Nice, France.; Hepato-Gastroenterology Department, Private Hospital Arras Les Bonnettes, Arras, France.; Gastroenterology and Hepatology Department, Nancy University Hospital, Vandoeuvre Les Nancy, France.; Medical Oncology Department, Morvan Hospital, Brest, France.; Medical Oncology Department, Institut Mutualiste Montsouris, Paris, France.; Hepato-Gastroenterology Department, Poitiers University Hospital, Poitiers, France.; Hepato-Gastroenterology and Digestive Oncology Department, Hopital Européen Georges Pompidou, Paris, France.; Biomaps, UMR1281 INSERM, CEA, CNRS, University of Paris-Saclay, 94800 Villejuif, France; Department of Imaging, Gustave Roussy Cancer Campus, University of Paris-Saclay, 94800 Villejuif, France.; Unicancer, Paris, France.; Department of Nuclear Medicine, Henri Becquerel Cancer Center, 76000 Rouen, France; QuantIF-LITIS (EA[Equipe d'Accueil] 4108), Faculty of Medicine, University of Rouen, 76000 Rouen, France.; Medical Oncology Department, Paoli-Calmettes Cancer Institute, Marseille, France. Electronic address: [email protected].

DOI: 10.1016/j.dld.2024.04.032