title: Longitudinal quality of life study in patients with metastatic gastric cancer. Analysis modalities and clinical applicability of QoL in randomized phase II trial in a digestive oncology.
abstract: OBJECTIVE
  The aim of this study was to compare the longitudinal quality of life (QoL) between LV5FU2-irinotecan and LV5FU2 alone or LV5FU2-cisplatin in a randomized Phase II trial in patients with metastatic gastric adenocarcinoma.
  
  
  METHODS
  Among 134 eligible patients, QLQ-C30 scores were collected and described at each 2 monthly follow-up visit during 6 months. The frequencies of QLQ-C30 score improvement were calculated and mixed models for repeated measurements were applied with or without extreme poorest imputation for missing scores. The "survival" until definitive global health score (GHS) deterioration was estimated.
  
  
  RESULTS
  At the 3rd follow-up, patients with a stable or improved global health ranged from 11% in the LV5FU2-cisplatin arm to 18% in the LV5FU2-irinotecan arm. The irinotecan-based-therapy presented 14 to 15 scores with a better QoL. The time until definitive GHS deterioration was globally similar between treatment arms.
  
  
  CONCLUSIONS
  This study highlights a better impact of LV5FU2-irinotecan and the interest of QoL assessment in phase II trials to complement the risk-benefit judgement.
authors.affiliation: INSERM EMI 106 and Federation Francophone de Cancerologie Digestive, Faculty of Medicine, 7 Bd Jeanne d'Arc, BP 879000, 21079 Dijon cedex. FBonnetain@dijon.fnclcc.fr
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Thierry
authors.initials: T
authors.lastname: Conroy
authors.forename: Patrick
authors.initials: P
authors.lastname: Arveux
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Raoul
authors.forename: Marc
authors.initials: M
authors.lastname: Giovannini
authors.forename: Pierre Luc
authors.initials: PL
authors.lastname: Etienne
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mitry
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Seitz
authors.forename: Philippe
authors.initials: P
authors.lastname: Rougier
authors.forename: Cécile
authors.initials: C
authors.lastname: Girault
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006304:Health Status; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016019:Survival Analysis
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin