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?

• DOI: 10.1007/s11136-013-0583-6
• Publication Date: 2013-11-25T11:28:15Z
• Authors: Amélie Anota; Zeinab Hamidou; Sophie Paget-Bailly; Benoist Chibaudel; Caroline Bascoul-...; Pascal Auquier; Virginie Westeel; Frederic Fiteni; Christophe Borg; Franck Bonnetain
• Keywords: Clinical endpoint

Longitudinal analysis of health-related quality life (HRQoL) remains unstandardized and compromises comparison results between trials. In oncology, despite available statistical approaches, are poorly used to change standards care, mainly due lack standardization the ability propose clinical meaningful results. this context, time deterioration (TTD) has been proposed as a modality longitudinal HRQoL for cancer patients. As tumor response progression, we develop RECIST criteria HRQoL.Several definitions TTD investigated in paper. We applied approach early breast metastatic pancreatic with 5-point minimal clinically important difference. cancer, was defined compared baseline score or best previous score. (arm 1: gemcitabine FOLFIRI.3, arm 2: alone), until definitive (TUDD) without death event.In study, 381 women were included. The median influenced by choice reference 98 patients enrolled. Patients Arm 1 presented longer TUDD than those 2 most scores. Results slightly different according definition applied.Currently, international ARCAD group supports idea developing colorectal liver metastasis, view using co-primary endpoint along parameter.