Health-related quality of life in patients with advanced renal cell carcinoma receiving pazopanib or placebo in a randomised phase III trial

Background: In a double-blind, randomised phase III trial of advanced renal cell carcinoma patients, pazopanib 800 mg 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 P20% 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. Conclusion: 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. (C) 2011 Elsevier Ltd. All rights reserved.