Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Proffered Paper session 2 - Gastrointestinal tumours, upper digestive

LBA77 - 5-fluorouracil and oxaliplatin with or without docetaxel in the first-line treatment of HER2 negative locally advanced (LA) unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma (GASTFOX-PRODIGE 51): A randomized phase III trial sponsored by the FFCD

Date

22 Oct 2023

Session

Proffered Paper session 2 - Gastrointestinal tumours, upper digestive

Topics

Clinical Research;  Cytotoxic Therapy

Tumour Site

Gastric Cancer;  Gastro-Oesophageal Junction Cancer

Presenters

Aziz Zaanan

Citation

Annals of Oncology (2023) 34 (suppl_2): S1281-S1282. 10.1016/S0923-7534(23)X0011-8

Authors

A. Zaanan1, O. Bouche2, C. de la Fouchardiere3, E. Samalin-Scalzi4, K. Le Malicot5, S. PERNOT6, P. Artru7, V. Ly Lebrun8, K. Aldabbagh9, F. Khemissa Akouz10, H. Castanie11, M. Laly12, D. Botsen13, M. Muller14, G. Roth15, T. Lecomte16, J.M. Phelip17, C. Lepage18, C. Louvet19

Author affiliations

  • 1 Gastroenterology And Digestive Oncology Department, Hopital Europeen Georges-Pompidou - AP-HP, 75015 - Paris/FR
  • 2 Department Of Digestive Oncology, CHU de Reims - Hôpital Robert Debré, 51092 - Reims, Cedex/FR
  • 3 Medical Oncology Department, Centre Léon Bérard, 69008 - Lyon/FR
  • 4 Medical Oncology, ICM - Institut du Cancer de Montpellier, 34298 - Montpellier, Cedex/FR
  • 5 Biostatistics, Fédération Francophone de Cancérologie Digestive, 21079 - Dijon/FR
  • 6 Hepato-gastroenterology Department, Institut Bergonié, 33000 - Bordeaux/FR
  • 7 Gi Oncology Department, Hôpital privé Jean Mermoz, 69373 - Lyon/FR
  • 8 Oncology Department, CHU Limoges - Hopital Dupuytren, 87042 - Limoges/FR
  • 9 Oncology Department, Polyclinique Saint Côme, 60204 - Compiegne/FR
  • 10 Hepato-gastroenterology Department, Centre Hospitalier de Perpignan - Hôpital Saint Jean, 66046 - Perpignan, Cedex /FR
  • 11 Oncology Department, Centre Catherine de Sienne, 44202 - Nantes/FR
  • 12 Hepato-gastroenterology Department, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche-sur-Yon/FR
  • 13 Hepato-gastroenterology Department, Institut Jean Godinot, 51100 - Reims/FR
  • 14 Hepato-gastro-enterology Department, CHRU Nancy, 54035 - Nancy/FR
  • 15 Hepato-gastroenterology Department, CHU Grenoble-Alpes - Le site nord à La Tronche - Hopital Michallon, 38700 - La Tronche/FR
  • 16 Hepato-gastroenterology Department, CHU de Tours, Hôpital Trousseau, 37170 - Chambray-lès-Tours/FR
  • 17 Hepato-gastroenterology Department, CHU Saint Etienne - Hopital Nord, 42055 - Saint-Étienne/FR
  • 18 Hepato Gastroenterology And Digestive Oncology Dept., CHU Dijon, 21079 - Dijon/FR
  • 19 Oncology Department, IMM - Institut Mutualiste Montsouris, 75014 - Paris/FR

Resources

Login to access the resources on OncologyPRO.

Abstract LBA77

Background

The perioperative FLOT triplet chemotherapy regimen is the standard of care for localized gastric and GEJ adenocarcinomas. We explored the superiority of a modified FLOT (mFLOT=TFOX regimen) vs FOLFOX in patients with advanced disease.

Methods

The GASTFOX phase III study compared FOLFOX versus a mFLOT/TFOX regimen (FOLFOX + docetaxel 50 mg/m2, q2w) in the first-line setting of patients with HER2-negative, LA unresectable or metastatic gastric or GEJ adenocarcinoma, with measurable disease, an ECOG PS 0 or 1, adequate organ function, and docetaxel naïve. The primary endpoint was PFS. Secondary endpoints included OS, ORR, safety, and quality of life (QoL). For survival outcomes, HR and 95% CI were estimated by a Cox proportional hazard (PH) model. In case of non-PH, the restricted mean survival time (RMST) was used to evaluate the treatment effect.

Results

Between 12/2016 and 12/2022, 507 patients were randomized 1:1 to FOLFOX (n=253) or mFLOT/TFOX (n=254). Baseline characteristics were similar between arms (overall: male, 78%; median age, 64; PS 1, 57%; GEJ, 56%; previous (neo)adjuvant treatment, 6%). Median follow-up (F/U) was 42.8 months (mo). As compared to FOLFOX, PFS was significantly improved in patients treated with mFLOT/TFOX (median: 7.59 vs 5.98 mo, non-PH / RMST at 12 mo F/U: 7.5 vs 6.6 mo, p=0.007). OS was also significantly improved by using mFLOT/TFOX (median: 15.08 vs 12.65 mo; HR 0.82 [0.68-0.99], p=0.048). ORR was also in favor of mFLOT/TFOX (66.0 vs 56.7%, p=0.038). Most common grade ≥3 TRAE were neuropathy (31.7 vs 19.7%), diarrhea (14.5 vs 6.4%) and neutropenia (26.1 vs 18.1%) respectively for mFLOT/TFOX and FOLFOX. Median time to deterioration in QoL (> 5 points loss in EORTC QLQC30) was longer in patients treated with mFLOT/TFOX (17.0 vs 13.7 mo; HR 0.75 [0.59-0.94], p=0.015).

Conclusions

The addition of docetaxel to FOLFOX significantly improved PFS, OS and ORR in first-line treatment of advanced HER2 negative gastric or GEJ adenocarcinomas. mFLOT/TFOX can be considered as a new therapeutic option for patients eligible for a triplet regimen.

Clinical trial identification

NCT03006432.

Editorial acknowledgement

Legal entity responsible for the study

Fédération Francophone de Cancérologie Digestive (FFCD).

Funding

Fédération Francophone de cancérologie Digestive (FFCD).

Disclosure

A. Zaanan: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Advisory Board: Astellas, Merck, Roche, Sanofi, Servier, Baxter, MSD, BMS, Pierre Fabre, Zymeworks, Daiichi Sankyo, AstraZeneca. O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, APMONIA THERAPEUTICS, Deciphera; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. C. de la Fouchardiere: Financial Interests, Personal, Advisory Board: Merck, Roche, Lilly, Bayer, Amgen, MSD, Servier, Pierre Fabre Oncologie, Bristol-Myers Squibb, Incyte, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Ipsen, Eisai, Servier, MSD, Daiichi Sankyo; Financial Interests, Institutional, Coordinating PI: Pierre Fabre Oncologie, Servier; Non-Financial Interests, Principal Investigator: Amgen, Daiichi Sankyo, MSD. E. Samalin-Scalzi: Financial Interests, Personal, Advisory Board: Pierre Fabre Onoclogy, Servier FRANCE, Astellas; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Institutional, Coordinating PI: Bayer; Non-Financial Interests, Member of Board of Directors: Unicancer GI, Prodige. S. Pernot: Financial Interests, Personal, Invited Speaker: Amgen, Bayer, Pierre Fabre; Financial Interests, Personal, Advisory Board: BMS, Merck, MSD, Servier. P. Artru: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Roche, Servier, Pierre Fabre, BMS, merck serono; Financial Interests, Personal, Invited Speaker: Amgen. F. Khemissa Akouz: Financial Interests, Personal, Invited Speaker: servier. H. Castanie: Financial Interests, Personal, Advisory Board: BMS, MSD. D. Botsen: Financial Interests, Personal, Advisory Board: Amgen, Servier, Sanofi, Pierre Fabre, Merck, Accord Healthcare. M. Muller: Financial Interests, Institutional, Invited Speaker: Servier. G. Roth: Financial Interests, Personal, Advisory Board: AstraZeneca, Accord Healthcare, AbbVie, Amgen, Bristol Myers Squibb, Ipsen, MSD, Sanofi, Servier, Viatris; Financial Interests, Personal, Other: Amgen, Bristol Myers Squibb, Ipsen, Sanofi, Lilly, Roche, AstraZeneca. T. Lecomte: Financial Interests, Personal, Invited Speaker: Ipsen, Pierre Fabre, AstraZeneca, BMS; Financial Interests, Personal, Advisory Board: SANOFI, Merck Serono, Servier, Amgen, Deciphera, Advanced Accelerator Applications, Pierre Fabre; Financial Interests, Institutional, Local PI: AstraZeneca, Mirati, ALX Oncology; Financial Interests, Institutional, Funding: Leo Pharma, Pierre Fabre. C. Lepage: Financial Interests, Personal, Advisory Board: Amgen, Advanced Accelerator Applications, Pierre Fabre, Servier. C. Louvet: Financial Interests, Personal, Advisory Board: MSD, Roche, Amgen; Financial Interests, Personal, Invited Speaker: Servier. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.