Francesco Cottone1, Gary S Collins2, Amelie Anota3, Kathrin Sommer4, Johannes M Giesinger5, Jacobien M Kieffer6, Neil K Aaronson6, Kristel Van Steen7, Emilie Charton3, Fausto Castagnetti8, Paola Fazi4, Marco Vignetti4, David Cella9, Fabio Efficace10. 1. Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit, Rome, Italy. Electronic address: f.cottone@gimema.it. 2. Centre for Statistics in Medicine, NDORMS, University of Oxford, Oxford, UK. 3. Methodology and Quality of Life in Oncology Unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France; French National Platform Quality of Life and Cancer, Besançon, France. 4. Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit, Rome, Italy. 5. Psychiatry II, Medical University of Innsbruck, University Hospital Innsbruck, Innsbruck, Austria. 6. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam. 7. GIGA-R Medical Genomics Unit, BIO 3 University of Liège, Liège, Belgium. 8. Institute of Hematology "L. and A. Seràgnoli", Department of Experimental, Diagnostic and Specialty Medicine, "S. Orsola-Malpighi" University Hospital, University of Bologna, Italy. 9. Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 10. Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit, Rome, Italy; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Abstract
OBJECTIVES: Major advances have recently been made in the treatments of cancer, which now also have the potential to improve patients' health-related quality of life (HRQOL). We propose the time to HRQOL improvement (TTI) and the time to sustained HRQOL improvement (TTSI) as potentially important cancer outcomes to be used in longitudinal HRQOL analyses. STUDY DESIGN AND SETTING: As proof of principle, we defined TTI and TTSI, using the Fine-Gray model to include competing risks in estimates, in a case study in real life of a cohort of newly diagnosed patients with cancer receiving a targeted therapy. HRQOL was evaluated before and during therapy with six assessments over a 24-month period, using the well-validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. RESULTS: For each assessed HRQOL domain, we assessed TTI and TTSI and estimated the cumulative incidence of patients' clinically meaningful improvements, also accounting for the occurrence of competing events. CONCLUSION: TTI and TTSI are potentially important outcomes in the era of modern anticancer therapies. The analysis of TTI and TTSI by competing risks approach will further add to the statistical methods that can be used to inform on the impact of cancer therapies on patients' HRQOL.
OBJECTIVES: Major advances have recently been made in the treatments of cancer, which now also have the potential to improve patients' health-related quality of life (HRQOL). We propose the time to HRQOL improvement (TTI) and the time to sustained HRQOL improvement (TTSI) as potentially important cancer outcomes to be used in longitudinal HRQOL analyses. STUDY DESIGN AND SETTING: As proof of principle, we defined TTI and TTSI, using the Fine-Gray model to include competing risks in estimates, in a case study in real life of a cohort of newly diagnosed patients with cancer receiving a targeted therapy. HRQOL was evaluated before and during therapy with six assessments over a 24-month period, using the well-validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. RESULTS: For each assessed HRQOL domain, we assessed TTI and TTSI and estimated the cumulative incidence of patients' clinically meaningful improvements, also accounting for the occurrence of competing events. CONCLUSION: TTI and TTSI are potentially important outcomes in the era of modern anticancer therapies. The analysis of TTI and TTSI by competing risks approach will further add to the statistical methods that can be used to inform on the impact of cancer therapies on patients' HRQOL.
Keywords:
Cancer; Competing risks; Health-related quality of life; Immunotherapy; Targeted therapies; Time to HRQOL improvement; Time to sustained HRQOL improvement
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