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

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 pr...

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Published in:	Digestive and liver disease Vol. 56; no. 8; pp. 1281 - 1287
Main Authors:	Botsen, Damien, Chabaud, Sylvie, Perrier, Hervé, Ammarguellat, Hanifa, Jestin-Le-Tallec, Véronique, Olesinski, Jonathan, Toullec, Clémence, Aparicio, Thomas, Ben Abdelghani, Meher, Borg, Christophe, Bouche, Olivier, Coutzac, Clélia, Devaud, Hervé, Di Fiore, Frédéric, Dubreuil, Olivier, Evesque, Ludovic, Huguenin, Bruno, Muller, Marie, Poureau, Pierre-Guillaume, Oularue, Emilie, Tougeron, David, Zaanan, Aziz, Ammari, Samy, De Sousa Carvalho, Nicolas, Decazes, Pierre, De La Fouchardiere, Christelle
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Ltd 01-08-2024
Subjects:	(2 à 4): Trifluridine/tipiracil Adenocarcinoma - drug therapy Adenocarcinoma - pathology Adult Advanced/metastatic gastric and gastroesophageal junction adenocarcinomas Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Drug Combinations Esophageal Neoplasms - drug therapy Esophageal Neoplasms - pathology Esophagogastric Junction - pathology Female Fluorouracil - administration & dosage Fluorouracil - therapeutic use Humans Leucovorin - administration & dosage Leucovorin - therapeutic use Male Middle Aged Multicenter Studies as Topic Nivolumab - administration & dosage Nivolumab - adverse effects Nivolumab - therapeutic use Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - therapeutic use Oxaliplatin - administration & dosage Oxaliplatin - therapeutic use Prospective Studies Pyrrolidines - administration & dosage Pyrrolidines - therapeutic use Receptor, ErbB-2 - metabolism Stomach Neoplasms - drug therapy Stomach Neoplasms - pathology Thymine Trifluridine - administration & dosage Trifluridine - therapeutic use (2 à 4): Trifluridine/tipiracil Advanced/metastatic gastric and gastroesophageal junction adenocarcinomas
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Summary:	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. 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. 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. 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).
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1590-8658 1878-3562 1878-3562
DOI:	10.1016/j.dld.2024.04.032