title: 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.
abstract: 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).
  
  
  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.
authors: Oncology Department, University Hospital, Madrid, Spain.
authors: D
authors: D
authors: Castellano
authors: X Garcia
authors: XG
authors: del Muro
authors: J L
authors: JL
authors: Pérez-Gracia
authors: J L
authors: JL
authors: González-Larriba
authors: M V
authors: MV
authors: Abrio
authors: M A
authors: MA
authors: Ruiz
authors: A
authors: A
authors: Pardo
authors: C
authors: C
authors: Guzmán
authors: S Díaz
authors: SD
authors: Cerezo
authors: E
authors: E
authors: Grande
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000627:therapeutic use*; D011788:Quality of Life; D000077210:Sunitinib; D011795:Surveys and Questionnaires
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D016898:Interferon-alpha; D011758:Pyrroles; D000077210:Sunitinib