Health-related Quality of Life in the Phase III LUME-Colon 1 Study: Comparison and Interpretation of Results From EORTC QLQ-C30 Analyses

Abstract

Based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) outputs from the LUME-Colon 1 study, we compared and discussed different statistical methods for evaluating health-related quality of life data in oncology clinical trials. The different analyses consistently showed that patients' overall global health status/quality of life status was not impaired by active treatment with nintedanib versus placebo, and that patients perceived some benefits with nintedanib compared with placebo. Introduction: We 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 healthrelated quality of life (HRQoL), and compared the results. Patients and Methods: Patients were randomized 1:1 to receive nintedanib 200 mg twice daily plus best supportive care (n ¼ 386) or matched placebo plus best supportive care (n ¼ 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. Results: 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, À0.004 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. Conclusion: 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.

Transarterial Radioembolization Versus Atezolizumab–Bevacizumab in Unresectable Hepatocellular Carcinoma: A Matching-Adjusted Indirect Comparison of Time to Deterioration in Quality of Life

“…Even though many clinical trials now include QOL as one of the key outcomes, its analysis is still not standardized, thereby hindering the comparability of results across trials and the literature [33,34]. Time to deterioration in QOL analyses rely, among other factors, on the threshold used to determine clinical relevance, with a change of 10 or more points on the GHS (in a single measurement) being one of the most common thresholds [33][34][35][36][37][38][39][40]. Although to a lesser extent, other thresholds have also been evaluated [41,42].…”

Effects of CALM intervention on neutrophil-to-lymphocyte ratio (NLR), fear of cancer recurrence and quality of life in patients with lung cancer

“…Quality of Life (QOL): The Quality of Life Questionnaire (V3.0) of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) is a globally used 30-item assessment scale used to determine the quality of life of clinical cancer patients [24]. The EORTC QLQ-C30 can be divided into 15 domains, including ve functional domains (physical, role, emotional, cognitive, and social functions), three symptom domains (fatigue, pain, and nausea and vomiting), one general health status (GHS)/QOL eld and six single items (dyspnea, loss of appetite, sleep disturbance, constipation, diarrhea, and economic impact of disease and treatment, with each item as a separate eld) [25]. This questionnaire is a survey of life and health status within one week.…”

Exercise Training Benefits Health-Related Quality of Life and Functional Capacity during Breast Cancer Chemotherapy: A Randomized Controlled Trial

“…To investigate changes at the patient level in HRQoL, two exploratory secondary analyses were further conducted. These included the status change analysis (31) and the thresholds for clinical importance (TCI) analysis (32). The status change analysis evaluated the proportion of patients who experienced, from baseline (t0) to the end of chemotherapy (t2), a clinically meaningful worsening (CMW; corresponding to a decrease of 10 or more units); clinically meaningful improvement (corresponding to an increase of 10 or more units); or stabilization (neither showing improvement nor worsening) in the QLQ-C30 domains (33).…”