Literature DB >> 28829992

Health-related quality of life results from the PRODIGE 5/ACCORD 17 randomised trial of FOLFOX versus fluorouracil-cisplatin regimen in oesophageal cancer.

C Bascoul-Mollevi1, S Gourgou2, M-P Galais3, J-L Raoul4, O Bouché5, J-Y Douillard6, A Adenis7, P-L Etienne8, B Juzyna9, L Bedenne10, T Conroy11.   

Abstract

BACKGROUND: A recent prospective randomised trial did not reveal significant differences in median progression-free survival between two chemoradiotherapy (CRT) regimens for inoperable non-metastatic oesophageal cancer patients. This secondary analysis aimed to describe the impact of CRT on health-related quality of life (HRQOL), physical functioning, dysphagia, fatigue and pain and to evaluate whether baseline HRQOL domains can predict overall survival. PATIENTS AND METHODS: A total of 267 patients were randomly assigned to receive with 50 Gy of radiotherapy in 25 fractions six cycles of FOLFOX or four cycles of fluorouracil and cisplatin on day 1. HRQOL was prospectively assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire version 3.0 with the oesophageal cancer module (QLQ-OES18).
RESULTS: Both groups showed high baseline compliance. Subsequently, compliance reduced to 41% at the 6-month follow-up. Baseline HRQOL scores showed no statistical differences between treatment arms. During treatment, both groups exhibited lower physical and social functioning and increased fatigue and dyspnoea, although dysphagia moderately improved in the fluorouracil-cisplatin arm only (p = 0.047). During follow-up, HRQOL scores revealed no significant differences between chemotherapy regimens. Linear mixed model exhibited a treatment-by-time interaction effect for dysphagia (p = 0.017) with a greater decrease in dysphagia in the fluorouracil-cisplatin group. Time until definitive deterioration analysis showed no significant differences in global HRQOL, functional or main symptom domains. However, time until definitive deterioration was significantly longer for the fluorouracil and cisplatin arm compared with FOLFOX for appetite loss (p = 0.002), QLQ-OES-18 pain (p = 0.008), trouble swallowing saliva (p = 0.011) and trouble talking (p = 0.020).
CONCLUSION: Analyses of HRQOL scores revealed no statistically significant differences between patients with inoperable non-metastatic oesophageal cancer treated by FOLFOX versus those treated with a fluorouracil-cisplatin regimen as part of definitive CRT.
Copyright © 2017 Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  Chemoradiotherapy; Oesophageal cancer; Oxaliplatin; Prognostic factors; Quality of life

Mesh:

Substances:

Year:  2017        PMID: 28829992     DOI: 10.1016/j.ejca.2017.07.038

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN: 0959-8049            Impact factor:   9.162


  5 in total

1.  Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.

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

2.  Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.

Authors:  Omeed Moaven; Konstantinos I Votanopoulos; Perry Shen; Paul Mansfield; David L Bartlett; Greg Russell; Richard McQuellon; John H Stewart; Edward A Levine
Journal:  Ann Surg Oncol       Date:  2019-11-12       Impact factor: 5.344

3.  Flexible modeling of longitudinal health-related quality of life data accounting for informative dropout in a cancer clinical trial.

Authors:  Audrey Winter; Benjamin Cuer; Thierry Conroy; Beata Juzyna; Sophie Gourgou; Caroline Mollevi; Célia Touraine
Journal:  Qual Life Res       Date:  2022-09-17       Impact factor: 3.440

4.  Handling informative dropout in longitudinal analysis of health-related quality of life: application of three approaches to data from the esophageal cancer clinical trial PRODIGE 5/ACCORD 17.

Authors:  B Cuer; C Mollevi; A Anota; E Charton; B Juzyna; T Conroy; C Touraine
Journal:  BMC Med Res Methodol       Date:  2020-09-03       Impact factor: 4.615

5.  Similar Quality of Life and Safety in Patients Receiving Inpatient or Outpatient Chemotherapy: A Focus on Esophageal Squamous Cell Carcinoma.

Authors:  Yen-Hao Chen; Su-Wei Chen; Hung-I Lu; Chien-Ming Lo; Shau-Hsuan Li
Journal:  Healthcare (Basel)       Date:  2020-11-01
  5 in total

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