title: Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial.
abstract: OBJECTIVE
  In an international, randomized phase III trial, sunitinib demonstrated statistically significant efficacy over interferon alfa (IFN-alpha) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC) (progression-free survival time, 11 v 5 months, respectively; P < .001; objective response rate, 31% v 6%, respectively; P < .001). We report health-related quality-of-life (QOL) results from this trial.
  
  
  METHODS
  Seven hundred fifty mRCC patients were randomly assigned to sunitinib (6-week cycles: 50 mg orally once daily for 4 weeks, followed by 2 weeks off) or IFN-alpha (9 million units subcutaneous injections, three times weekly). QOL measures included the Functional Assessment of Cancer Therapy-General (FACT-G), the FACT-Kidney Symptom Index-15 item (FKSI-15), and the EuroQoL-5D's utility score (EQ-5D Index) and its visual analog scale (EQ-VAS). The primary QOL end point was the FKSI Disease-Related Symptoms (FKSI-DRS) subscale. Higher scores indicated better outcomes (better QOL or fewer symptoms). Data were analyzed for the intent-to-treat population using mixed-effects models, supplemented with pattern-mixture models.
  
  
  RESULTS
  Patients receiving sunitinib reported higher FKSI-15 and FKSI-DRS scores at each cycle than those receiving IFN-alpha, with a significant difference in the overall least squares means (3.27 and 1.98, respectively; P < .0001). Similarly, differences in least squares means for FACT-G (and all subscales), EQ-5D Index, and EQ-VAS were all significantly favorable for sunitinib (P < .01). Per pre-established thresholds, between-treatment differences in the mean scores were clinically meaningful after cycle 4 for FKSI-DRS and at all assessments for FKSI-15, FACT-G, and the FACT-G functional well-being subscale.
  
  
  CONCLUSIONS
  Sunitinib provides superior QOL compared with IFN-alpha in mRCC patients.
authors.affiliation: Center on Outcomes, Research and Education, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, 1001 University Place, Evanston, IL 60201, USA. d-cella@northwestern.edu
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Jim Z
authors.initials: JZ
authors.lastname: Li
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cappelleri
authors.forename: Andrew
authors.initials: A
authors.lastname: Bushmakin
authors.forename: Claudie
authors.initials: C
authors.lastname: Charbonneau
authors.forename: Sindy T
authors.initials: ST
authors.lastname: Kim
authors.forename: Isan
authors.initials: I
authors.lastname: Chen
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Motzer
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001315:Australia; D001938:Brazil; D002170:Canada; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011758:Pyrroles / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D012426:Russia; D000077210:Sunitinib; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D016898:Interferon-alpha; D011758:Pyrroles; D000077210:Sunitinib