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

Abstract

Purpose: To compare epirubicin, cisplatin, and capecitabine (ECX) with fluorouracil, leucovorin, and rinotecan (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-totreatment failure (TTF) of the first-line therapy. Secondary criteria were progression-free surviva (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% v84%; P