Rosine Guimbaud1, Christophe Louvet2, Pauline Ries2, Marc Ychou2, Emilie Maillard2, Thierry André2, Jean-Marc Gornet2, Thomas Aparicio2, Suzanne Nguyen2, Ahmed Azzedine2, Pierre-Luc Etienne2, Eveline Boucher2, Christine Rebischung2, Pascal Hammel2, Philippe Rougier2, Laurent Bedenne2, Olivier Bouché2. 1. Rosine Guimbaud, Centre Hospitalier Universitaire Toulouse, Toulouse; Christophe Louvet, Institut Mutualiste Montsouris; Thierry André, Hôpital Saint Antoine; Jean-Marc Gornet, Centre Hospitalier Universitaire Saint Louis (Assistance Publique-Hôpitaux de Paris); Pascal Hammel, Hôpital Beaujon; Philippe Rougier, Hôpital Européen Georges Pompidou, Paris; Pauline Ries, Institut Paoli Calmettes, Marseille; Marc Ychou, Institut Régional du Cancer Val d'Aurelle, Montpellier; Emilie Maillard, Fédération Francophone de Cancérologie Digestive; Laurent Bedenne, Centre Hospitalier Universitaire, Dijon; Thomas Aparicio, Hôpital Avicenne, Bobigny; Suzanne Nguyen, Hôpital Général, Beauvais; Ahmed Azzedine, Hôpital Général, Montélimard; Pierre-Luc Etienne, Clinique Armoricaine, Saint-Brieuc; Eveline Boucher, Centre Eugène Marquis, Rennes; Christine Rebischung, Hôpital A. Michallon, Grenoble; Olivier Bouché, Centre Hospitalier Universitaire Robert Debré, Reims, France. guimbaud.r@chu-toulouse.fr. 2. Rosine Guimbaud, Centre Hospitalier Universitaire Toulouse, Toulouse; Christophe Louvet, Institut Mutualiste Montsouris; Thierry André, Hôpital Saint Antoine; Jean-Marc Gornet, Centre Hospitalier Universitaire Saint Louis (Assistance Publique-Hôpitaux de Paris); Pascal Hammel, Hôpital Beaujon; Philippe Rougier, Hôpital Européen Georges Pompidou, Paris; Pauline Ries, Institut Paoli Calmettes, Marseille; Marc Ychou, Institut Régional du Cancer Val d'Aurelle, Montpellier; Emilie Maillard, Fédération Francophone de Cancérologie Digestive; Laurent Bedenne, Centre Hospitalier Universitaire, Dijon; Thomas Aparicio, Hôpital Avicenne, Bobigny; Suzanne Nguyen, Hôpital Général, Beauvais; Ahmed Azzedine, Hôpital Général, Montélimard; Pierre-Luc Etienne, Clinique Armoricaine, Saint-Brieuc; Eveline Boucher, Centre Eugène Marquis, Rennes; Christine Rebischung, Hôpital A. Michallon, Grenoble; Olivier Bouché, Centre Hospitalier Universitaire Robert Debré, Reims, France.
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.
RCT Entities:
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.
Authors: E Charton; B Cuer; F Cottone; F Efficace; C Touraine; Z Hamidou; F Fiteni; F Bonnetain; M-C Woronoff-Lemsi; C Bascoul-Mollevi; A Anota Journal: Qual Life Res Date: 2019-11-27 Impact factor: 4.147
Authors: Peter S N van Rossum; Nadia Haj Mohammad; Frank P Vleggaar; Richard van Hillegersberg Journal: Nat Rev Gastroenterol Hepatol Date: 2017-12-13 Impact factor: 46.802
Authors: Haeseong Park; Ramon U Jin; Andrea Wang-Gillam; Rama Suresh; Caron Rigden; Manik Amin; Benjamin R Tan; Katrina S Pedersen; Kian-Huat Lim; Nikolaos A Trikalinos; Abhilasha Acharya; Megan L Copsey; Katherine A Navo; Ashley E Morton; Feng Gao; A Craig Lockhart Journal: JAMA Oncol Date: 2020-08-01 Impact factor: 31.777