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Quality of Life Research
Published in: Quality of Life Research 1/2015

Open Access 01-01-2015 | Quantitative Methods Special Section

Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?

Authors: Amélie Anota, Zeinab Hamidou, Sophie Paget-Bailly, Benoist Chibaudel, Caroline Bascoul-Mollevi, Pascal Auquier, Virginie Westeel, Frederic Fiteni, Christophe Borg, Franck Bonnetain

Published in: Quality of Life Research | Issue 1/2015

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Abstract

Purpose

Longitudinal analysis of health-related quality of life (HRQoL) remains unstandardized and compromises comparison of results between trials. In oncology, despite available statistical approaches, results are poorly used to change standards of care, mainly due to lack of standardization and the ability to propose clinical meaningful results. In this context, the time to deterioration (TTD) has been proposed as a modality of longitudinal HRQoL analysis for cancer patients. As for tumor response and progression, we propose to develop RECIST criteria for HRQoL.

Methods

Several definitions of TTD are investigated in this paper. We applied this approach in early breast cancer and metastatic pancreatic cancer with a 5-point minimal clinically important difference. In breast cancer, TTD was defined as compared to the baseline score or to the best previous score. In pancreatic cancer (arm 1: gemcitabine with FOLFIRI.3, arm 2: gemcitabine alone), the time until definitive deterioration (TUDD) was investigated with or without death as event.

Results

In the breast cancer study, 381 women were included. The median TTD was influenced by the choice of the reference score. In pancreatic cancer study, 98 patients were enrolled. Patients in Arm 1 presented longer TUDD than those in Arm 2 for most of HRQoL scores. Results of TUDD were slightly different according to the definition of deterioration applied.

Conclusion

Currently, the international ARCAD group supports the idea of developing RECIST for HRQoL in pancreatic and colorectal cancer with liver metastasis, with a view to using HRQoL as a co-primary endpoint along with a tumor parameter.
Appendix
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Metadata
Title
Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?
Authors
Amélie Anota
Zeinab Hamidou
Sophie Paget-Bailly
Benoist Chibaudel
Caroline Bascoul-Mollevi
Pascal Auquier
Virginie Westeel
Frederic Fiteni
Christophe Borg
Franck Bonnetain
Publication date
01-01-2015
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 1/2015
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-013-0583-6

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