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Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population

Background: The purpose of this study is to evaluate the impact on the health-related quality of life (HRQoL) of sunitinib versus interferon-alpha (IFN-α) treatment in patients with metastatic renal cell carcinoma (mRCC). Patients and methods: In all, 304 mRCC patients (European cohort) were randomi...

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Autores principales: Castellano, D., del Muro, X. Garcia, Pérez-Gracia, J. L., González-Larriba, J. L., Abrio, M. V., Ruiz, M. A., Pardo, A., Guzmán, C., Cerezo, S. Díaz, Grande, E.
Formato: Texto
Lenguaje:English
Publicado: Oxford University Press 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2768734/
https://www.ncbi.nlm.nih.gov/pubmed/19549706
http://dx.doi.org/10.1093/annonc/mdp067
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author Castellano, D.
del Muro, X. Garcia
Pérez-Gracia, J. L.
González-Larriba, J. L.
Abrio, M. V.
Ruiz, M. A.
Pardo, A.
Guzmán, C.
Cerezo, S. Díaz
Grande, E.
author_facet Castellano, D.
del Muro, X. Garcia
Pérez-Gracia, J. L.
González-Larriba, J. L.
Abrio, M. V.
Ruiz, M. A.
Pardo, A.
Guzmán, C.
Cerezo, S. Díaz
Grande, E.
author_sort Castellano, D.
collection PubMed
description Background: The purpose of this study is to evaluate the impact on the health-related quality of life (HRQoL) of sunitinib versus interferon-alpha (IFN-α) treatment in patients with metastatic renal cell carcinoma (mRCC). Patients and methods: In all, 304 mRCC patients (European cohort) were randomized 1 : 1 to receive sunitinib (50 mg/day for 4 weeks, followed by 2 weeks off) or IFN-α (9 million units s.c. injection three times/week). The following questionnaires were completed (days 1 and 28 per cycle): Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Symptom Index and the EuroQol Group's EQ-5D self-report questionnaire (EQ-5D). Results correspond to an ongoing trial with progression-free survival time as primary end point, and patients were still being followed up. Data were analyzed using repeated measures mixed effects models (MEMs) that allow the inclusion of initial differences and uncompleted repeated measures, with the assumption of data missing at random. Six-cycle results were included. Results: Results consistently showed that patients in sunitinib group experienced statistically significantly milder kidney-related symptoms, better cancer-specific HRQoL and general health status (in social utility scores) during the study period as measured by these patient-reported outcome end points. No statistical differences between groups were found on the FACT-G physical well-being subscale or the EQ-5D VAS values. Conclusions: Results from MEM showed the sunitinib's benefit on HRQoL compared with IFN-α.
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spelling pubmed-27687342009-10-30 Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population Castellano, D. del Muro, X. Garcia Pérez-Gracia, J. L. González-Larriba, J. L. Abrio, M. V. Ruiz, M. A. Pardo, A. Guzmán, C. Cerezo, S. Díaz Grande, E. Ann Oncol Original Articles Background: The purpose of this study is to evaluate the impact on the health-related quality of life (HRQoL) of sunitinib versus interferon-alpha (IFN-α) treatment in patients with metastatic renal cell carcinoma (mRCC). Patients and methods: In all, 304 mRCC patients (European cohort) were randomized 1 : 1 to receive sunitinib (50 mg/day for 4 weeks, followed by 2 weeks off) or IFN-α (9 million units s.c. injection three times/week). The following questionnaires were completed (days 1 and 28 per cycle): Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Symptom Index and the EuroQol Group's EQ-5D self-report questionnaire (EQ-5D). Results correspond to an ongoing trial with progression-free survival time as primary end point, and patients were still being followed up. Data were analyzed using repeated measures mixed effects models (MEMs) that allow the inclusion of initial differences and uncompleted repeated measures, with the assumption of data missing at random. Six-cycle results were included. Results: Results consistently showed that patients in sunitinib group experienced statistically significantly milder kidney-related symptoms, better cancer-specific HRQoL and general health status (in social utility scores) during the study period as measured by these patient-reported outcome end points. No statistical differences between groups were found on the FACT-G physical well-being subscale or the EQ-5D VAS values. Conclusions: Results from MEM showed the sunitinib's benefit on HRQoL compared with IFN-α. Oxford University Press 2009-11 2009-06-23 /pmc/articles/PMC2768734/ /pubmed/19549706 http://dx.doi.org/10.1093/annonc/mdp067 Text en © The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. The online version of this article has been published under an open access model. users are entitle to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that: the original authorship is properly and fully attributed; the Journal and the European Society for Medical Oncology are attributed as the original place of publication with the correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org
spellingShingle Original Articles
Castellano, D.
del Muro, X. Garcia
Pérez-Gracia, J. L.
González-Larriba, J. L.
Abrio, M. V.
Ruiz, M. A.
Pardo, A.
Guzmán, C.
Cerezo, S. Díaz
Grande, E.
Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title_full Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title_fullStr Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title_full_unstemmed Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title_short Patient-reported outcomes in a phase III, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a European population
title_sort patient-reported outcomes in a phase iii, randomized study of sunitinib versus interferon-α as first-line systemic therapy for patients with metastatic renal cell carcinoma in a european population
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2768734/
https://www.ncbi.nlm.nih.gov/pubmed/19549706
http://dx.doi.org/10.1093/annonc/mdp067
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