TY - JOUR
T1 - Trifluridine/tipiracil + oxaliplatin ± nivolumab vs FOLFOX ± nivolumab in HER2 negative advanced oesogastric adenocarcinoma
T2 - The PRODIGE73-UCGI40-LOGICAN trial
AU - Botsen, Damien
AU - Chabaud, Sylvie
AU - Perrier, Hervé
AU - Ammarguellat, Hanifa
AU - Jestin-Le-Tallec, Véronique
AU - Olesinski, Jonathan
AU - Toullec, Clémence
AU - Aparicio, Thomas
AU - Ben Abdelghani, Meher
AU - Borg, Christophe
AU - Bouche, Olivier
AU - Coutzac, Clélia
AU - Devaud, Hervé
AU - Di Fiore, Frédéric
AU - Dubreuil, Olivier
AU - Evesque, Ludovic
AU - Huguenin, Bruno
AU - Muller, Marie
AU - Poureau, Pierre Guillaume
AU - Oularue, Emilie
AU - Tougeron, David
AU - Zaanan, Aziz
AU - Ammari, Samy
AU - De Sousa Carvalho, Nicolas
AU - Decazes, Pierre
AU - De La Fouchardiere, Christelle
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/8/1
Y1 - 2024/8/1
N2 - 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).
AB - 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).
KW - (2 à 4): Trifluridine/tipiracil
KW - Advanced/metastatic gastric and gastroesophageal junction adenocarcinomas
UR - http://www.scopus.com/inward/record.url?scp=85194150314&partnerID=8YFLogxK
U2 - 10.1016/j.dld.2024.04.032
DO - 10.1016/j.dld.2024.04.032
M3 - Article
C2 - 38762353
AN - SCOPUS:85194150314
SN - 1590-8658
VL - 56
SP - 1281
EP - 1287
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
IS - 8
ER -