Patient-reported outcomes in individuals with advanced gastrointestinal stromal tumor treated with ripretinib in the fourth-line setting: analysis from the phase 3 INVICTUS trial

Background: Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVIC‑ TUS phase 3 trial, ripretinib increased median progression-free survival and prolonged overall survival vs. placebo in ≥fourth-line advanced GIST. Here, we report prespecifed analysis of quality of life (QoL) as assessed by patientreported outcome (PRO) measures and an exploratory analysis evaluating the impact of alopecia on QoL. Methods: In the INVICTUS trial (NCT03353753), QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; physical function, role function, overall health, and overall QoL) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5 L; visual analogue scale). Analysis of covari‑ ance (ANCOVA) models compared changes in scores from baseline to treatment cycle 2, day 1 within and between ripretinib and placebo. Within the ripretinib arm, repeated measures models assessed the impact of alopecia on QoL. Results: Patients receiving ripretinib maintained QoL (as assessed by the EORTC QLQ-C30 and EQ-5D-5 L PRO meas‑ ures) from baseline to cycle 2, day 1 whereas QoL declined with placebo, resulting in clinically signifcant diferences between treatments (nominal PExperimentele farmacotherapi