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. 2025 Jul 28:S1590-8658(25)00927-2.
doi: 10.1016/j.dld.2025.07.018. Online ahead of print.

FOLFIRINOX or FOLFOX for locally advanced or metastatic small bowel adenocarcinoma: PRODIGE 86 - FFCD-GONO - ENGIC 02 - FOLFIRINOX SBA phase II randomized trial

Thomas Aparicio  1 , Anthony Turpin  2 , Aziz Zaanan  3 , Christelle de la Fouchardière  4 , Karine Le Malicot  5 , Sara Lonardi  6 , Dominik Paul Modest  7 , Richard Wilson  8 , Chiara Cremolini  9 , Alexej Ballhausen  7 , Janet Graham  8 , Annika Kurreck  7 , Meriem Guarssifi  5 , Magali Svrcek  10 , Pierre Laurent-Puig  11 , Sylvain Manfredi  12
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Free article

FOLFIRINOX or FOLFOX for locally advanced or metastatic small bowel adenocarcinoma: PRODIGE 86 - FFCD-GONO - ENGIC 02 - FOLFIRINOX SBA phase II randomized trial

Thomas Aparicio et al. Dig Liver Dis. .
Free article

Abstract

Background: Small bowel adenocarcinoma (SBA) is rare. Palliative chemotherapy was evaluated mainly in retrospective studies. No randomized trial has been previously performed to evaluate front line chemotherapy in advanced SBA.

Methods: Randomized, non-comparative, open-label, multi-center phase II study to evaluate mFOLFOX (D1=D15: oxaliplatin 85 mg/m2, folinic acid: 400 mg/m2, 5FU bolus: 400 mg/m2 followed by 5FU: 2400 mg/m2 IV infusion over 46 h) and mFOLFIRINOX (mFOLFOX plus irinotecan 180 mg/m2, without 5FU bolus) in the first line treatment of unresectable locally advanced or metastatic SBA. Ampullary carcinoma and MSI-H/dMMR SBA are excluded. The primary endpoint is to assess the percentage of patients alive without progression at 8 months. In each arm, assuming a null hypothesis of 40 % of patients free of progression at 8 months, and a target percentage of 55 %, 65 patients per arm are needed with 85 % power and 10 % one-sided type I error. Randomizations started in February 2024.

Keywords: Crohn disease; FOFIRINOX; Lynch syndrome; Rare cancer; Small bowel adenocarcinoma.

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Conflict of interest statement

Declaration of competing interest Thomas Aparicio: Honoraria: Bayer, Amgen, BMS, MSD, Pierre Fabre, Takeda, Merck; congress: Servier, Pierre Fabre, MSD, BMS, Amgen, Novartis Anthony Turpin: personal fees from Servier, Viatris, Incyte Bioscience, BMS, Merck and grants and personal fees from AstraZeneca and MSD. Aziz Zaanan: has participated in consulting or advisory boards (or both) for Amgen, Astellas, Merck, Sanofi, Servier, Bayer, Beigene, MSD, BristolMyers Squibb, Pierre Fabre, Astra Zeneca, Daiichi Sankyo, Abbvie, and Gilead Christelle de la Fouchardière: holding an advisory role with Amgen, Bayer, BMS, Daichi-Sankyo, Eisai, Imescia, Incyte, Lilly, Merck, MSD, Pierre Fabre Oncologie, Roche, and Servier; receiving grants from Pierre Fabre and Servier outside of the submitted work; receiving fees from Ipsen, Eisai, Pierre Fabre, Servier, being an invited speaker outside of the submitted work Karine Le Malicot: declares no conflict of interests Sara Lonardi: personal honoraria as invited speaker from Amgen, Astra Zeneca, Bristol-Myers Squibb, Incyte, GSK, Lilly, Merck Serono, MSD, Pierre-Fabre, Roche, Servier; participation in advisory board for Amgen, Astellas, Astra Zeneca, Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, GSK, Incyte, Lilly, Merck Serono, MSD, Servier, Takeda, Rottapharm, Beigene, Fosum Pharma, Nimbus Therapeutics Dominik Paul Modest: Honoraria: Merck Serono, Amgen, Roche, Servier, Bristol Myers Squibb, Taiho Pharmaceutical, Merck Sharp & Dohme, Pierre Fabre, Onkowissen, Sanofi, Lilly Consulting or Advisory Role: Merck Serono, Amgen, Merck Sharp & Dohme, Roche, Servier, Incyte, Bristol Myers Squibb, Pierre Fabre, Lilly, Cor2Ed, IQvia, OnkowissenResearch Funding: Amgen, Servier. Travel, Accommodations, Expenses: Amgen, Merck Serono, Servier Richard Wilson: declares no conflict of interests Chiara Cremolini: Advisory board or consultant role with AbbVie, Astra Zeneca, Bayer, Bicara Therapeutics, BMS, GSK, Lilly, Merck, Mirati, MSD, Nordic Pharma, Roche, Pfizer, Pierre Fabre, Revolution Medicine, Rottapharm, Shionogi, Takeda, Tempus. Invited speaker with compensation for AbbVie, Amgen, Bayer, Merck Serono, MSD, Pierre Fabre, Servier, Takeda. Research grants by Amgen, Merck, Pierre Fabre, Roche, Seagen (Pfizer), Servier, Tempus. Alexej Ballhausen: Stock and other ownership interests: BioNTech SE. Honoraria: Amgen. Research funding: Amgen (Inst). Travel, Accommodations, Expenses: Amgen. Janet Graham: honoraria for educational events organized by Servier. L.S. received speaker and consultancy fees from MSD, AstraZeneca, Servier, Bayer, Merck, Amgen and Pierre-Fabre. Annika Kurreck: Honoraria: Amgen, Servier, MSD, Merck, Takeda, Pierre Fabre, Astra Zeneca, Consulting or Advisory Role: MSD, Merck, Takeda. Travel, Accommodations, Expenses: Amgen, Servier, MSD, Merck, medac GmbH, Takeda, Pierre Fabre, Astra. Meriem Guarssifi: declares no conflict of interests Magali Svcrek: consulting fees from Amgen, Astellas, Owkin, MSD, and Servier and reports travel, accommodations, and expenses from Astellas and MSD Pierre Laurent Puig: Consultancy, advisory fees, and honoraria: Servier, Pierre Fabre, BMS, Merck and Biocartis Sylvain Manfredi: travel accommodation from MSD, AMGEN

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