title: Health-related quality of life in patients with advanced renal cell carcinoma receiving pazopanib or placebo in a randomised phase III trial.
abstract: BACKGROUND
  In a double-blind, randomised phase III trial of advanced renal cell carcinoma patients, pazopanib 800mg QD (n=290) versus placebo (n=145) significantly prolonged progression-free survival (hazard ratio (HR)=0.46, 95% confidence interval [CI] 0.34-0.62, p-value<0.0001), without important differences in health-related quality of life (HRQoL). This post-hoc analysis evaluated time to HRQoL deterioration and whether tumour response/stabilisation was associated with HRQoL improvement.
  
  
  METHODS
  HRQoL was assessed using EORTC QLQ-C30 and EQ-5D. Effect of pazopanib on time to ⩾20% decline from baseline in summary scores was estimated for all patients and by prior treatment. Analyses were conducted for different HRQoL deterioration thresholds. HRQoL changes were stratified by benefit and compared: complete response (CR) or partial response (PR) versus progressive disease (PD); CR/PR versus stable disease (SD), and SD versus PD.
  
  
  RESULTS
  There was a trend for pazopanib patients to be less likely than placebo patients to experience ⩾20% HRQoL deterioration in EORTC-QLQ-C-30 global health status/QOL scale (HR=0.77; 95% CI 0.57-1.03, not significant). Results by prior treatment and different HRQoL deterioration thresholds were similar. Patients with CR/PR and SD experienced significantly less HRQoL deterioration than those with PD (p<0.001, p=0.0024, respectively); mean differences between patients with CR/PR and PD exceeded the pre-determined minimally important difference (MID). Differences between patients with SD and PD did not exceed pre-determined MID. Results were generally consistent across treatment and EQ-5D summary scores.
  
  
  CONCLUSIONS
  Results support the favourable benefit-risk profile of pazopanib and suggest patients experiencing tumour response/stabilisation also may have better HRQoL compared to those without this response.
authors.affiliation: Northwestern University Feinberg School of Medicine, Evanston, IL 60611, USA. d-cella@northwestern.edu
authors.forename: D
authors.initials: D
authors.lastname: Cella
authors.forename: A S
authors.initials: AS
authors.lastname: Pickard
authors.forename: M S
authors.initials: MS
authors.lastname: Duh
authors.forename: A
authors.initials: A
authors.lastname: Guerin
authors.forename: N
authors.initials: N
authors.lastname: Mishagina
authors.forename: L
authors.initials: L
authors.lastname: Antràs
authors.forename: M P
authors.initials: MP
authors.lastname: Neary
authors.forename: L
authors.initials: L
authors.lastname: McCann
authors.forename: R
authors.initials: R
authors.lastname: Hodge
authors.forename: C N
authors.initials: CN
authors.lastname: Sternberg
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000523:psychology; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D007191:Indazoles; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000627:therapeutic use*; D011788:Quality of Life; D013449:Sulfonamides / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D007191:Indazoles; D011743:Pyrimidines; D013449:Sulfonamides; C516667:pazopanib