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. 2024 Aug;56(8):1281-1287.
doi: 10.1016/j.dld.2024.04.032. Epub 2024 May 17.

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

Damien Botsen  1 , Sylvie Chabaud  2 , Hervé Perrier  3 , Hanifa Ammarguellat  4 , Véronique Jestin-Le-Tallec  5 , Jonathan Olesinski  6 , Clémence Toullec  7 , Thomas Aparicio  8 , Meher Ben Abdelghani  9 , Christophe Borg  10 , Olivier Bouche  11 , Clélia Coutzac  12 , Hervé Devaud  13 , Frédéric Di Fiore  14 , Olivier Dubreuil  15 , Ludovic Evesque  16 , Bruno Huguenin  17 , Marie Muller  18 , Pierre-Guillaume Poureau  19 , Emilie Oularue  20 , David Tougeron  21 , Aziz Zaanan  22 , Samy Ammari  23 , Nicolas De Sousa Carvalho  24 , Pierre Decazes  25 , Christelle De La Fouchardiere  26
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Free article

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

Damien Botsen et al. Dig Liver Dis. 2024 Aug.
Free article

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).

Keywords: (2 à 4): Trifluridine/tipiracil; Advanced/metastatic gastric and gastroesophageal junction adenocarcinomas.

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Conflict of interest statement

Conflict of interest D.B. reports personal fees as a speaker and/or in an advisory role from Accord Healthcare, Amgen, Sanofi, Servier, and Pierre Fabre, outside the submitted work. O.B. reports personal fees as a speaker and/or in an advisory role from Merck, Bayer, Apmonia Therapeutics, Deciphera, Takeda, MSD, Amgen, Servier, and Pierre Fabre, outside the submitted work. C.C. reports personal fees as speaker and/or in an advisory role from Amgen, Astra-Zeneca, Pierre Fabre, Daiichy Sankyo, BMS, MSD, Merck Serono, Servier, outside the submitted work. O.D. reports personal fees as speaker and/or in an advisory role from Astra-Zeneca, BMS, MSD, Merck Serono, Sanofi, Servier outside the submitted work. DT: Honoraria: Amgen, Roche, Sanofi, Bristol Myers Squibb, Merck Serono, MSD, Bristol Myers Squibb, Servier, Ipsen, Pierre Fabre, AstraZeneca, Takeda, BeiGene, Astra Zeneca. Consulting or Advisory Role: Sanofi, MSD, Pierre Fabre, AstraZeneca, Novartis, Takeda. Research Funding: AstraZeneca (Inst), Servier (Inst), Roche (Inst), MSD (Inst), BTG (Inst). Travel, Accommodations, Expenses: Roche, Amgen, Bristol Myers Squibb, MSD, Pierre Fabre. CDLF: Honoraria: Amgen, AstraZeneca,Bayer, BeiGene, Bristol Myers Squibb, Ipsen, Merck, MSD, Pierre Fabre, Servier, Roche, Sanofi, Takeda. Consulting or Advisory Role: MSD, Pierre Fabre, AstraZeneca, Takeda. Research Funding: Servier (Inst), Roche (Inst), MSD (Inst). Travel, Accommodations, Expenses: Roche, Amgen, MSD, Pierre Fabre, Servier.

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