PCN217 Health State Utility Values of Patients With Locally Advanced or Metastatic Urothelial Carcinoma: Analysis Based on the JAVELIN Bladder 100 Trial

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Metastatic urothelial carcinoma (mUC) is an aggressive, symptomatic cancer that impacts quality of life. In the phase 3 JAVELIN Bladder 100 trial (JB-100) [NCT02603432], avelumab (anti–PD-L1) first-line (1L) maintenance + best supportive care (BSC) significantly prolonged overall survival (primary endpoint) vs BSC alone in patients with mUC without disease progression with 1L chemotherapy. Mean utilities at each scheduled assessment, presented previously, were similar between avelumab + BSC and BSC. This study estimated health-state utilities required for cost-utility analysis. Data from the JB-100 trial were analyzed to determine health-state utilities for progression-free and progressive disease health states. EQ-5D-5L questionnaires were administered at day 1 of each 4-week treatment cycle, at the end of treatment/withdrawal, and at 3 follow-up visits. Following NICE guidelines, EQ-5D-5L responses were converted to EQ-5D-3L responses using a published algorithm, and utility scores were obtained using UK tariffs. No missing data were imputed. Exploratory analyses using mixed-effects repeated measures linear regression were conducted to investigate the effect of tumor progression and proximity to death (defined as ≤30 days until death) as time-varying covariates. Of 700 patients enrolled in JB-100, 653 (93.3%) had available utility data at both baseline and ≥1 follow-up visit and were eligible for analysis. Tumor progression had a negative impact on health-related quality of life (HRQOL): EQ-5D utility decrement was 0.075 (95% CI, 0.064-0.085, p<0.001). The utilities for progression-free and progressed patients were 0.772 (95% CI, 0.760-0.785) and 0.698 (95% CI, 0.684-0.712), respectively. Furthermore, within the 30-day period before death, utilities were lower by −0.202 (95% CI, −0.246 to −0.158; p<0.001). Tumor progression and proximity to death were associated with a statistically significant worsening in HRQOL among patients with mUC. Therefore, treatments that delay progression and death likely provide longer quality-adjusted life-years.