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?
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Quality of Life in Oncology Clinical Research Platform, Besançon, France, aanota@chu-besancon.fr.
authors.forename: Amélie
authors.initials: A
authors.lastname: Anota
authors.forename: Zeinab
authors.initials: Z
authors.lastname: Hamidou
authors.forename: Sophie
authors.initials: S
authors.lastname: Paget-Bailly
authors.forename: Benoist
authors.initials: B
authors.lastname: Chibaudel
authors.forename: Caroline
authors.initials: C
authors.lastname: Bascoul-Mollevi
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.forename: Frederic
authors.initials: F
authors.lastname: Fiteni
authors.forename: Christophe
authors.initials: C
authors.lastname: Borg
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D006301:Health Services Needs and Demand; D006304:Health Status; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D011788:Quality of Life; D066066:Response Evaluation Criteria in Solid Tumors; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000093542:Gemcitabine