25550
document
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 . OBJECTIVES 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 . CONCLUSION 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 .
25551
Intervention_Pharmacological
LV5FU2-irinotecan
25552
Intervention_Pharmacological
LV5FU2 alone
25553
Intervention_Pharmacological
LV5FU2-cisplatin
25554
Intervention_Pharmacological
LV5FU2-cisplatin
25555
Intervention_Pharmacological
LV5FU2-irinotecan
25556
Intervention_Pharmacological
LV5FU2-irinotecan
25557
Outcome_Physical
quality of life
25558
Outcome_Physical
QoL
25559
Outcome_Physical
longitudinal quality of life ( QoL )
25560
Outcome_Physical
QLQ-C30 scores
25561
Outcome_Physical
frequencies of QLQ-C30 score improvement
25562
Outcome_Mortality
survival " until definitive global health score ( GHS ) deterioration
25563
Outcome_Physical
global health
25564
Outcome_Physical
QoL
25565
Outcome_Physical
time until definitive GHS deterioration
25566
Outcome_Physical
QoL assessment