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Clinical Trial
. 2014 Nov 1;32(31):3520-6.
doi: 10.1200/JCO.2013.54.1011. Epub 2014 Oct 6.

Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study

Rosine Guimbaud  1 , Christophe Louvet  2 , Pauline Ries  2 , Marc Ychou  2 , Emilie Maillard  2 , Thierry André  2 , Jean-Marc Gornet  2 , Thomas Aparicio  2 , Suzanne Nguyen  2 , Ahmed Azzedine  2 , Pierre-Luc Etienne  2 , Eveline Boucher  2 , Christine Rebischung  2 , Pascal Hammel  2 , Philippe Rougier  2 , Laurent Bedenne  2 , Olivier Bouché  2
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Clinical Trial

Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive, Fédération Nationale des Centres de Lutte Contre le Cancer, and Groupe Coopérateur Multidisciplinaire en Oncologie) study

Rosine Guimbaud et al. J Clin Oncol. .

Erratum in

  • Errata.
    [No authors listed] [No authors listed] J Clin Oncol. 2015 Apr 20;33(12):1416. doi: 10.1200/jco.2015.61.9759. J Clin Oncol. 2015. PMID: 25883365 Free PMC article. No abstract available.

Abstract

Purpose: To compare epirubicin, cisplatin, and capecitabine (ECX) with fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatments in patients with advanced gastric or esophagogastric junction (EGJ) adenocarcinoma.

Patients and methods: This open, randomized, phase III study was carried out in 71 centers. Patients with locally advanced or metastatic gastric or EGJ cancer were randomly assigned to receive either ECX as first-line treatment (ECX arm) or FOLFIRI (FOLFIRI arm). Second-line treatment was predefined (FOLFIRI for the ECX arm and ECX for the FOLFIRI arm). The primary criterion was time-to-treatment failure (TTF) of the first-line therapy. Secondary criteria were progression-free survival (PFS), overall survival (OS), toxicity, and quality of life.

Results: In all, 416 patients were included (median age, 61.4 years; 74% male). After a median follow-up of 31 months, median TTF was significantly longer with FOLFIRI than with ECX (5.1 v 4.2 months; P = .008). There was no significant difference between the two groups in median PFS (5.3 v 5.8 months; P = .96), median OS (9.5 v 9.7 months; P = .95), or response rate (39.2% v 37.8%). First-line FOLFIRI was better tolerated (overall rate of grade 3 to 4 toxicity, 69% v 84%; P < .001; hematologic adverse events [AEs], 38% v 64.5%; P < .001; nonhematologic AEs: 53% v 53.5%; P = .81).

Conclusion: FOLFIRI as first-line treatment for advanced gastric and EGJ cancer demonstrated significantly better TTF than did ECX. Other outcome results indicate that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents.

Trial registration: ClinicalTrials.gov NCT00374036.

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