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Poster display session

2025 - PRODIGE 51 - GASTFOX: Phase III randomised trial evaluating FOLFOX with or without DOCETAXEL (TFOX) as 1st line chemotherapy for locally advanced or metastatic oesophago-gastric adenocarcinoma

Date

09 Sep 2017

Session

Poster display session

Presenters

Aziz Zaanan

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

A. Zaanan1, E. Samalin2, C. Louvet3, C. Montérymard4, F. Khemissa5, O. Bouche6, S. Louafi7, F. Ghiringhelli8, P. Bernard9, B. Chibaudel10, P. Artru11, Y. Molin12, N. Baba-Hamed13, O. Romano14, T. Aparicio15, P. Michel16, P. Rougier17, D. Tougeron18, S. Manfredi19, J. Taieb20

Author affiliations

  • 1 Department Of Gastroenterology, Hopital European Georges Pompidou, 75015 - Paris/FR
  • 2 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 3 Medical Oncology, Institute Mutualiste Montsouris, 75014 - Paris/FR
  • 4 Biostatistics, FFCD-, 21079 - Dijon/FR
  • 5 Department Of Hepatology Gastroenterology, CH Perpignan, Saint Jean Hospital, 66046 - Perpignan/FR
  • 6 Department Of Hepato-gastroenterology, CHU Robert Debré, 51092 - Reims/FR
  • 7 Department Of Oncology, Hopital Sud Francilien, 91106 - CORBEIL ESSONNES/FR
  • 8 Medical Oncology, Georges-Francois Leclerc Cancer Center, 21000 - Dijon/FR
  • 9 Oncology, Sainte-Marguerite Clinic, 83400 - Hyeres/FR
  • 10 Department Of Oncology, Hopital Franco Britannique, 92300 - LEVALLOIS PERRET/FR
  • 11 Gastroenterology, Hôpital Privé Jean Mermoz, 69373 - Lyon/FR
  • 12 Oncology, La Sauvegarde Clinic, 69009 - LYON/FR
  • 13 Oncology, Groupe Hospitalier Paris Saint-Joseph, 75014 - Paris/FR
  • 14 Department Of Gastroenterology, Institut Cancérologie Lille Métropole, 59657 - VILLENEUVE D'ASQ/FR
  • 15 Department Of Gastroenterology, Saint Louis Hospital, 75010 - Paris/FR
  • 16 Department Of Oncology, CHU Charles Nicolle, 76031 - Rouen/FR
  • 17 Oncology, Hôpital Hôtel Dieu CHU, 44093 - NANTES/FR
  • 18 Department Of Gastroenterology, CHU Poitiers, Jean Bernard Hôpital, 86021 - Poitiers/FR
  • 19 Gastroenterology, CHU Le Bocage, FFCD, Burgundy University, INSERM U866, 21079 - Dijon/FR
  • 20 Department Of Gastroenterology And Digestive Oncology, Hôpital Européen Georges Pompidou, 75015 - Paris/FR
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Resources

Abstract 2025

Background

In advanced gastric cancer, doublet regimen with cisplatin and fluoropyrimidine is considered as a 1st-line standard treatment (trt). Taxane is also effective in 2nd line. The addition of docetaxel (75 mg/m2) to cisplatin (75 mg/m2) and 5-fluorouracil (“DCF regimen”) every 3 weeks has been shown to improve efficacy of 1st-line trt in a phase III trial. However, this regimen was associated with more frequent grade 3-4 toxicities, such as diarrhea, neutropenia and complicated neutropenia (febrile neutropenia or neutropenic infection). Oxaliplatin has been shown to be more tolerable than cisplatin with the same efficacy. The addition of docetaxel at 50 mg/m2 every 2 weeks to the FOLFOX (TFOX regimen) showed to be active and tolerable in phase II studies and less toxic as compared DCF regimen. The aim of this current phase III study is to compare FOLFOX to TFOX in 1st line trt of advanced gastric cancer.

Trial design

The major eligibility criteria are: Patient ≥ 18 years, WHO PS ≤ 1, with histological proven gastric or gastro-oesophageal junction HER2 negative adenocarcinoma, metastatic or locally advanced measurable disease (RECIST v1.1 criteria). Trt is administered every 14 days.Table:

773TiP

FOLFOX (BRAS A)TFOX (BRAS B)
Folinic acid (D1)400 mg/m2400 mg/m2
Oxaliplatin (D1)85 mg/m285 mg/m2
5FU bolus (D1)400 mg/m2
5FU continu (D1-2)2400 mg/m22400 mg/m2
Docétaxel (D1)50 mg/m2

Trt has to be administrated until disease progression or unacceptable toxicity. The primary criterion is radiological/clinical progression-free survival (PFS). A difference of 2 months for the median PFS in favor of TFOX is expected (5.5 months in FOLFOX arm vs 7.5 months in TFOX arm), HR = 0.73. (α = 5%, power of 90%, O’Brien – Fleming function). An interim analysis is planned at 227 events (progression or death) for early efficacy or futility search. Secondary criteria are: overall survival, objective response rate, therapeutic index, toxicity, time to final deterioration in quality of life. Stratification factors are: centre, WHO PS, adjuvant chemotherapy or radio-chemotherapy, tumour stage, primary tumour location and pathological subtype. 17 patients have been randomized over the 506 planned since 19/12/2016.

Clinical trial identification

EudraCT n° 2016-002331-16; NCT03006432

Legal entity responsible for the study

FFCD

Funding

None

Disclosure

A. Zaanan: Consulting and/or advisory board for Roche, Merck Serono, Amgen, Sanofi, Lilly. E. Samalin: Personal grants for consultancy for Sanofi, Lilly, Novartis, Bayer, Roche, Ipsen, Amgen, Merck. F. Khemissa: Personal grants for consultancy for Sanofi, Roche, Ipsen, Bayer. O. Bouche: Personal grants for consultancy for Roche, Merck, Amgen, Lilly, Novartis Oncologie. F. Ghiringhelli: Personal grants for consultancy for Amgen and Merck. B. Chibaudel: Consulting: Sanofi, Lilly. Honoraria: Bayer, Kephren, Kantar H. Travels: Roche, Sanofi, Amgen, Merck, Lilly. Y. Molin: Regional board for Janssen. O. Romano: Roche, Pierre Fabre, Sanofi. T. Aparicio: Personal grants for consultancy for Amgen, Roche, Bayer, Pierre Fabre, Novartis Oncologie, Pfizer, Sanofi, Vifor Pharma, Ipsen Pharma. P. Michel: Personal grants for consultancy for Sanofi, Lilly. J. Taieb: Personal grants for consultancy for Amgen, Baxalta, Celgene, Lilly, Merck, Msd, Pfizer, Roche, Sanofi, Abbvie. All other authors have declared no conflicts of interest.

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