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

Autor: Lenz, Heinz Joseph, Argilés Martínez, Guillem, Yoshino, Takayuki, Lonardi, Sara, Falcone, Alfredo, Limón, María Luisa, Sobrero, Alberto, Hastedt, Claudia, Peil, Barbara, Voss, Florian, Griebsch, Ingolf, Van Cutsem, Eric, Universitat Autònoma de Barcelona
Přispěvatelé: Institut Català de la Salut, [Lenz HJ] Division of Medical Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA. [Argiles G] Servei d'Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Yoshino T] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. [Lonardi S] Phase 1 Trial Unit and Medical Oncology Unit 1, Istituto Oncologico Veneto IRCCS, Padova, Italy. [Falcone A] Department of Oncology, University of Pisa, Pisa, Italy. [Limón ML] Medical Oncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain, Vall d'Hebron Barcelona Hospital Campus
Rok vydání: 2019
Předmět:
Indoles
Colorectal cancer
Other subheadings::Other subheadings::/drug therapy [Other subheadings]
chemistry.chemical_compound
0302 clinical medicine
Environmental Health::Science::Environmental Quality::Quality of Life [PUBLIC HEALTH]
Quality of life
Sickness Impact Profile
Surveys and Questionnaires
Còlon - Càncer
Medicine
Eortc qlq c30
Gastroenterology
Prognosis
neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias intestinales::neoplasias colorrectales [ENFERMEDADES]
humanities
Survival Rate
Oncology
Qualitat de vida
HRQoL
MMRM
Nintedanib
QoL
Time to deterioration
salud ambiental::ciencia::calidad ambiental::calidad de vida [SALUD PÚBLICA]
030220 oncology & carcinogenesis
Colonic Neoplasms
030211 gastroenterology & hepatology
medicine.medical_specialty
Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores]
Antineoplastic Agents
Placebo
Article
03 medical and health sciences
Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [DISEASES]
Internal medicine
Humans
Social functioning
Health related quality of life
business.industry
medicine.disease
Confidence interval
chemistry
Quality of Life
Medicaments - Administració
business
Follow-Up Studies
Zdroj: Scientia
Dipòsit Digital de Documents de la UAB
Universitat Autònoma de Barcelona
Clin Colorectal Cancer
ISSN: 1533-0028
Popis: 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 health-related 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 = 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. 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, −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. 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.
Databáze: OpenAIRE
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