Lenz, Heinz-JosefArgiles, GuillemYoshino, TakayukiLonardi, SaraFalcone, AlfredoLimón, María LuisaSobrero, AlbertoHastedt, ClaudiaPeil, BarbaraVoss, FlorianGriebsch, IngolfVan Cutsem, Eric2023-02-082023-02-082019-09-04http://hdl.handle.net/10668/14978We used European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) data from the LUME-Colon 1 study to illustrate different methods of statistical analysis for health-related quality of life (HRQoL), and compared the results. Patients were randomized 1:1 to receive nintedanib 200 mg twice daily plus best supportive care (n = 386) or matched placebo plus best supportive care (n = 382). Five methods (mean treatment difference averaged over time, using a mixed-effects growth curve model; mixed-effects models for repeated measurements (MMRM); time-to-deterioration (TTD); status change; and responder analysis) were used to analyze EORTC QLQ-C30 global health status (GHS)/QoL and scores from functional scales. Overall, GHS/QoL and physical functioning deteriorated over time. Mean treatment difference slightly favored nintedanib over placebo for physical functioning (adjusted mean, 2.66; 95% confidence interval [CI], 0.97-4.34) and social functioning (adjusted mean, 2.62; 95% CI, 0.66-4.47). GHS/QoL was numerically better with nintedanib versus placebo (adjusted mean, 1.61; 95% CI, -0.004 to 3.27). MMRM analysis had similar results, with better physical functioning in the nintedanib group at all timepoints. There was no significant delay in GHS/QoL deterioration (10%) and physical functioning (16%) with nintedanib versus placebo (TTD analysis). Status change analysis showed a higher proportion of patients with markedly improved GHS/QoL and physical functioning in the nintedanib versus placebo groups. Responder analysis showed a similar, less pronounced pattern. Analyses of EORTC QLQ-C30 data showed that HRQoL was not impaired by treatment with nintedanib versus placebo. Analysis and interpretation of HRQoL endpoints should consider symptom type and severity and course of disease.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/HRQoLMMRMNintedanibQoLTime to deteriorationAntineoplastic AgentsColonic NeoplasmsFollow-Up StudiesHumansIndolesPrognosisQuality of LifeSickness Impact ProfileSurveys and QuestionnairesSurvival Rateresearch article31628043open access10.1016/j.clcc.2019.08.0051938-0674PMC7505163https://www.clinical-colorectal-cancer.com/article/S1533-0028(18)30525-5/pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505163/pdf