title: Quality of life in patients with advanced renal cell carcinoma treated with temsirolimus or interferon-alpha.
abstract: BACKGROUND
  Temsirolimus was approved in Europe as first-line treatment of poor-prognosis advanced renal cell carcinoma (advRCC) based on significant clinical benefits.
  
  
  METHODS
  Patients with advRCC and multiple poor-prognostic factors were randomly assigned to receive 25 mg intravenous temsirolimus weekly, interferon-alpha (titrated to 18 mU) three times weekly, or 15 mg intravenous temsirolimus weekly plus 6 mU of interferon-alpha three times weekly. EuroQol-5D utility score (EQ-5D index) and the EQ-5D visual analogue scale (EQ-VAS) responses were recorded. For analysis, patients were required to have their EQ-5D data recorded at baseline, week 12, and last visit after week 12. The analysis was conducted using last-visit data and a repeated-measures mixed-effect (RMME) model to evaluate quality-of-life differences between temsirolimus and interferon-alpha, controlling for baseline covariates.
  
  
  RESULTS
  Average EQ-5D score at the last measure was significantly higher in patients receiving temsirolimus compared with interferon-alpha: by 0.10 on EQ-5D index (P=0.0279) and by 6.61 on EQ-VAS (P=0.0095). In the RMME model, the least-square mean for on-treatment EQ-5D index score was 0.590 with temsirolimus and 0.492 with interferon-alpha (P=0.0022).
  
  
  CONCLUSIONS
  Temsirolimus is associated with significantly higher EQ-5D scores compared with interferon-alpha in patients with previously untreated poor-prognosis advRCC.
authors.affiliation: Global Access, Pfizer, Collegeville, Pennsylvania, USA.
authors.forename: S
authors.initials: S
authors.lastname: Yang
authors.forename: P
authors.initials: P
authors.lastname: de Souza
authors.forename: E
authors.initials: E
authors.lastname: Alemao
authors.forename: J
authors.initials: J
authors.lastname: Purvis
mesh_terms: D000203:Activities of Daily Living; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000523:psychology; D006304:Health Status; D006801:Humans; D007371:Interferon-gamma / Q000009:adverse effects*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000970:Antineoplastic Agents; C401859:temsirolimus; D007371:Interferon-gamma; D020123:Sirolimus
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