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

Autor: Patrick Schöffski, Suzanne George, Michael C. Heinrich, John R. Zalcberg, Sebastian Bauer, Hans Gelderblom, César Serrano, Robin L. Jones, Steven Attia, Gina D’Amato, Ping Chi, Peter Reichardt, Claus Becker, Kelvin Shi, Julie Meade, Rodrigo Ruiz-Soto, Jean-Yves Blay, Margaret von Mehren
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMC Cancer, Vol 22, Iss 1, Pp 1-10 (2022)
Druh dokumentu: article
ISSN: 1471-2407
DOI: 10.1186/s12885-022-10379-9
Popis: Abstract Background Ripretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVICTUS phase 3 trial, ripretinib increased median progression-free survival and prolonged overall survival vs. placebo in ≥ fourth-line advanced GIST. Here, we report prespecified analysis of quality of life (QoL) as assessed by patient-reported 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 covariance (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 measures) from baseline to cycle 2, day 1 whereas QoL declined with placebo, resulting in clinically significant differences between treatments (nominal P
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