PCN151 - Longitudinal Analysis Of Adjusted EQ-5D Utility Score At Baseline, Progression-Free Survival, And Progression For Lenvatinib Versus Sorafenib

Abstract

To compare the impact of treatment on generic health related quality of life (QoL) factors for patients treated with lenvatinib (LEN) versus sorafenib (SOR) using the European Quality of Life questionnaire Five Dimension Scale (EQ-5D). This was a multicenter, randomized, open-label, non-inferiority Phase 3 study comparing LEN to SOR as first-line in patients with unresectable hepatocellular carcinoma systemic treatments. Longitudinal modelling of the EQ-5D Health Utility Index (HUI) was conducted to estimate the effect of treatment assignment (LEN versus SOR) on change from Baseline. Overall, a total of 954 patients (478 patients in the LEN treatment arm and 476 in the SOR treatment arm) were randomized. Baseline demographic and health information characteristics were not significantly different between treatment arms. In the EQ-5D, the mean change from Baseline visual analogue scale scores were observed to decrease with worsening modified Response Evaluation Criteria in Solid Tumors categories, with associated standardized effect size scores that decreased as disease severity increased. LEN and SOR arms had similar health utility scores at all baseline (Baseline: 0.804 versus 0.811, respectively). Previously presented post-Baseline progression-free survival visits were 19.7% lower for LEN (adjusted change from Baseline: -0.041 versus -0.050, respectively). A slight improvement in HUI scores (10.3%) were observed in LEN patients at disease progression based on the first post-Baseline progression visit (adjusted change from Baseline: -0.110 versus -0.122). Overall, these data illustrate that the LEN and SOR arms had similar health utility scores at all post-baseline, progression-free survival visits, with a slight improvement in HUI scores observed in LEN patients at disease progression. The change from Baseline to progression free survival and change from Baseline to post-progression was smaller for LEN compared to SOR.