Abstract
9096 Background: In a double-blind, randomized Phase III trial of patients with advanced renal cell carcinoma, pazopanib 800mg QD (n=290) significantly prolonged progression-free survival (PFS) compared to placebo (n=145; median PFS, 9.2 vs. 4.2 months, hazard ratio [HR]=0.46, 95% confidence interval [CI] 0.34-0.62, p-value<0.0001), with no important difference in health-related quality of life (HRQoL) compared to placebo. This post-hoc analysis evaluated time to HRQoL decline by treatment group and whether tumor response/stabilization was associated with HRQoL benefit. Methods: HRQoL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and EQ-5D index and visual analog scale (VAS). Effect of pazopanib on time to ≥20% decline from baseline HRQoL was estimated for all patients and by prior treatment (treatment-naïve vs. cytokine-pretreated). HRQoL changes were stratified by best response (based on Response Evaluation Criteria in Solid Tumors) during best response period (best response to progression) and compared: complete response (CR) or partial response (PR) vs. progressive disease (PD); stable disease (SD) vs. PD. Comparisons were for all patients and by treatment arm. Sensitivity analyses were conducted for different HRQoL deterioration thresholds. Results: There was a trend for pazopanib vs. placebo patients to be less likely to experience ≥20% HRQoL decline in QLQ-C30 global QOL scale (HR=0.77; 95% CI 0.57-1.03, p=.0817). Results by prior treatment and different HRQoL decline thresholds were similar. Patients with CR/PR experienced significantly less HRQoL deterioration to a meaningful extent compared to PD patients (adjusted difference, QLQ-C30: 11.8; 95% CI 7.1 - 16.5, p<0.001; EQ-5D index: 0.15; 95% CI 0.09 – 0.21, p<0.001; EQ-5D VAS: 10.8; 95% CI 5.7-16.0, p<0.001); mean differences exceeded previously established minimally important differences. Results were similar across treatment arms. Conclusions: Results support the acceptable tolerability profile of pazopanib and suggest patients who had tumor response also experienced better HRQoL compared to those without response.
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