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Annals of Oncology Advance Access originally published online on June 23, 2009
Annals of Oncology 2009 20(11):1803-1812; doi:10.1093/annonc/mdp067
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© 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

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

D. Castellano1, X. Garcia del Muro2, J. L. Pérez-Gracia3, J. L. González-Larriba4, M. V. Abrio5, M. A. Ruiz6, A. Pardo6, C. Guzmán7, S. Díaz Cerezo7,* and E. Grande7

1 Oncology Department, 12 de Octubre University Hospital, Madrid
2 Department of Oncology, Catalan Institute of Oncology, Barcelona
3 Department of Oncology, University Clinic of Navarra, Navarra
4 Department of Oncology, San Carlos University Hospital, Madrid
5 Department of Oncology, Virgen del Rocío Hospital, Sevilla
6 Faculty of Psychology, Autonomous University of Madrid, Madrid
7 Medical Department, Pfizer Spain, Madrid, Spain

* Correspondence to: Dr S. Díaz Cerezo, Health Outcomes Research Department, Medical Unit, Pfizer Spain, Avda. de Europa 20-B, Parque Empresarial La Moraleja, 28108 Alcobendas, Madrid, Spain. Tel: +34-914909860; Fax: +34-914909704; E-mail: silvia.diaz{at}pfizer.com

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-{alpha}) 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-{alpha} (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-{alpha}.

Key words: health-related quality of life, interferon-{alpha}, patient-reported outcomes, sunitinib

Received for publication July 17, 2008. Revision received December 4, 2008. Accepted for publication February 23, 2009.


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