caa a22 4500 606177760 CHVBK 20210128100753.0 cr unu---uuuuu 210128e20150101xx s 000 0 eng 10.1007/s11136-013-0583-6 doi (NATIONALLICENCE)springer-10.1007/s11136-013-0583-6 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? [Elektronische Daten] [Amélie Anota, Zeinab Hamidou, Sophie Paget-Bailly, Benoist Chibaudel, Caroline Bascoul-Mollevi, Pascal Auquier, Virginie Westeel, Frederic Fiteni, Christophe Borg, Franck Bonnetain] 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. The Author(s), 2013 Health-related quality of life nationallicence Clinical trials nationallicence Oncology nationallicence Longitudinal analysis nationallicence Time to deterioration nationallicence CI : Confidence interval nationallicence EORTC : European Organisation for Research and Treatment of Cancer nationallicence HR : Hazard ratio nationallicence HRQoL : Health-related quality of life nationallicence GLMM : General linear mixed model nationallicence IRT : Item response theory nationallicence MCID : Minimal clinically important difference nationallicence OS : Overall survival nationallicence RS : Response shift nationallicence SD : Standard deviation nationallicence TTD : Time to deterioration nationallicence TUDD : Time until definitive deterioration nationallicence Anota Amélie Quality of Life in Oncology Clinical Research Platform, Besançon, France aut Hamidou Zeinab Quality of Life in Oncology Clinical Research Platform, Besançon, France aut Paget-Bailly Sophie Methodological and Quality of Life in Oncology Unit, EA 3181, University Hospital of Besançon, 2 Place Saint-Jacques, 25030, Besançon Cedex, France aut Chibaudel Benoist Medical Oncology Department, University Hospital Saint-Antoine, Paris, France aut Bascoul-Mollevi Caroline Department of Biostatistics, Regional Cancer Institute, Montpellier, France aut Auquier Pascal Quality of Life in Oncology Clinical Research Platform, Besançon, France aut Westeel Virginie Pneumology Department, University Hospital of Besançon, Besançon, France aut Fiteni Frederic Methodological and Quality of Life in Oncology Unit, EA 3181, University Hospital of Besançon, 2 Place Saint-Jacques, 25030, Besançon Cedex, France aut Borg Christophe Medical Oncology Department, University Hospital of Besançon, Besançon, France aut Bonnetain Franck Quality of Life in Oncology Clinical Research Platform, Besançon, France aut Quality of Life Research Springer International Publishing 24/1(2015-01-01), 5-18 0962-9343 24:1<5 2015 24 11136 https://doi.org/10.1007/s11136-013-0583-6 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-013-0583-6 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Anota Amélie Quality of Life in Oncology Clinical Research Platform, Besançon, France aut NATIONALLICENCE 700 1- Hamidou Zeinab Quality of Life in Oncology Clinical Research Platform, Besançon, France aut NATIONALLICENCE 700 1- Paget-Bailly Sophie Methodological and Quality of Life in Oncology Unit, EA 3181, University Hospital of Besançon, 2 Place Saint-Jacques, 25030, Besançon Cedex, France aut NATIONALLICENCE 700 1- Chibaudel Benoist Medical Oncology Department, University Hospital Saint-Antoine, Paris, France aut NATIONALLICENCE 700 1- Bascoul-Mollevi Caroline Department of Biostatistics, Regional Cancer Institute, Montpellier, France aut NATIONALLICENCE 700 1- Auquier Pascal Quality of Life in Oncology Clinical Research Platform, Besançon, France aut NATIONALLICENCE 700 1- Westeel Virginie Pneumology Department, University Hospital of Besançon, Besançon, France aut NATIONALLICENCE 700 1- Fiteni Frederic Methodological and Quality of Life in Oncology Unit, EA 3181, University Hospital of Besançon, 2 Place Saint-Jacques, 25030, Besançon Cedex, France aut NATIONALLICENCE 700 1- Borg Christophe Medical Oncology Department, University Hospital of Besançon, Besançon, France aut NATIONALLICENCE 700 1- Bonnetain Franck Quality of Life in Oncology Clinical Research Platform, Besançon, France aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/1(2015-01-01), 5-18 0962-9343 24:1<5 2015 24 11136