J Z Musoro1, S C Sodergren2, C Coens1, A Pochesci1, M Terada3, M T King4, M A G Sprangers5, M Groenvold6, K Cocks7, G Velikova8, H-H Flechtner9, A Bottomley1. 1. European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. 2. School of Health Sciences, University of Southampton, Southampton, UK. 3. Japan Clinical Oncology Group, Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan. 4. Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia. 5. Department of Medical Psychology, Amsterdam University Medical Center, Amsterdam, The Netherlands. 6. Department of Public Health, University of Copenhagen and Bispebjerg Hospital, Copenhagen, Denmark. 7. Adelphi Values, Bollington, Cheshire, UK. 8. Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. 9. Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.
Abstract
AIM: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses the health-related quality of life of patients in cancer trials. There are currently no minimally important difference (MID) guidelines for the EORTC QLQ-C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ-C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials. METHOD: The data were obtained from three published EORTC trials that treated CRC patients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ-C30 scales. Anchor-based MIDs for within-group change and between-group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution-based MIDs were also examined. RESULTS: Anchor-based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ-C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (-11 to -5) points for within-group change and 5 to 15 (-10 to -4) for between-group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points. CONCLUSIONS: These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.
AIM: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses the health-related quality of life of patients in cancer trials. There are currently no minimally important difference (MID) guidelines for the EORTC QLQ-C30 for colorectal cancer (CRC). This study aims to estimate MIDs for the EORTC QLQ-C30 scales in patients with advanced CRC treated with chemotherapy and enrolled in clinical trials. METHOD: The data were obtained from three published EORTC trials that treated CRCpatients using chemotherapy. Potential anchors were selected from clinical variables based on their correlation with EORTC QLQ-C30 scales. Anchor-based MIDs for within-group change and between-group change were estimated via the mean change method and linear regression, respectively, and summarized using weighted correlation. Distribution-based MIDs were also examined. RESULTS: Anchor-based MIDs were determined for deterioration in 8 of the 14 EORTC QLQ-C30 scales and in 9 scales for improvement, and varied by scale, direction of change and anchor. MIDs for improvement (deterioration) ranged from 6 to 18 (-11 to -5) points for within-group change and 5 to 15 (-10 to -4) for between-group change. Summarized MIDs (in absolute values) per scale mostly ranged from 5 to 10 points. CONCLUSIONS: These findings have clinical relevance for the interpretation of treatment efficacy and the design of clinical trials by informing sample size requirements.
Authors: S Kopetz; A Grothey; E Van Cutsem; R Yaeger; H Wasan; T Yoshino; J Desai; F Ciardiello; F Loupakis; Y S Hong; N Steeghs; T K Guren; H-T Arkenau; P Garcia-Alfonso; A Belani; X Zhang; J Tabernero Journal: ESMO Open Date: 2022-05-30
Authors: Marijke B Coomans; Marthe C M Peeters; Johan A F Koekkoek; Jan W Schoones; Jaap Reijneveld; Martin J B Taphoorn; Linda Dirven Journal: Cancers (Basel) Date: 2020-11-24 Impact factor: 6.639
Authors: Petra Huehnchen; Nikola Bangemann; Sandra Lischewski; Stefanie Märschenz; Friedemann Paul; Tanja Schmitz-Hübsch; Jens-Uwe Blohmer; Cornelia Eberhardt; Geraldine Rauch; Agnes Flöel; Sophie Adam; Philipp Schwenkenbecher; Ivo Meinhold-Heerlein; Oliver Hoffmann; Tjalf Ziemssen; Matthias Endres; Wolfgang Boehmerle Journal: Front Med (Lausanne) Date: 2022-08-11