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.
RCT Entities:
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.
Authors: Bruno Kovic; Xuejing Jin; Sean Alexander Kennedy; Mathieu Hylands; Michal Pedziwiatr; Akira Kuriyama; Huda Gomaa; Yung Lee; Morihiro Katsura; Masafumi Tada; Brian Y Hong; Sung Min Cho; Patrick Jiho Hong; Ashley M Yu; Yasmin Sivji; Augustin Toma; Li Xie; Ludwig Tsoi; Marcin Waligora; Manya Prasad; Neera Bhatnagar; Lehana Thabane; Michael Brundage; Gordon Guyatt; Feng Xie Journal: JAMA Intern Med Date: 2018-12-01 Impact factor: 21.873