Treatment with ripretinib (Qinlock®) as fourth-line or greater therapy helps to maintain quality of life (QoL) in patients with advanced gastrointestinal stromal tumor (GIST) as measured through patient-reported outcomes (PROs) according to a study published in BMC Cancer.
Analysis of prespecified PROs collected during the phase 3 INVICTUS clinical trial showed that treatment with ripretinib maintained QoL in patients from baseline to day 1 of the second cycle of treatment (C2D1). In contrast, QoL declined in the placebo group of the study during the same period resulting in clinically significant differences between the 2 groups (nominal P <.01).
Read more about ripretinib for GIST
“PRO assessments in the INVICTUS trial demonstrate that patients with advanced GIST on fourth-line or greater therapy maintain QoL and function while receiving ripretinib out to C2D1 compared with patients receiving placebo,” the authors said.
QoL was measured through changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5 L). When comparing subsets of the questionnaires, statistical differences were found between the ripretinib and placebo groups for all subsets including the EQ-5D-5 L visual analog scale (P =.004), EORTC QLQ-C30 physical function (P =.004), EORTC QLQ-C30 role function (P =.001), EORTC QLQ-C30 overall health (P =.001), and EORTC QLQ-C30 overall quality of life (P =.001).
Longitudinal changes in PRO scores show that patients reported stable values in their role and physical function, health status, and health quality of life from baseline to day 1 of cycle 10 of treatment (roughly 8 months). This effect was longer than the 6.3-month progression-free survival (PFS) previously reported from the study.
The most frequent treatment-emergent adverse event (TEAE) reported during the study was alopecia which was reported in 52% of patients. Most of these patients developed grade 1 alopecia (77%), categorized as hair loss of less than 50%. No significant difference was observed in QoL between ripretinib patients with and without alopecia.
“Patients receiving ripretinib were not negatively impacted by alopecia as related to longitudinal QoL and function,” the authors said.
A total of 84 patients received treatment during the double-blind portion of the trial but only 71 patients had baseline and C2D1 data available.
Schöffski P, George S, Heinrich MC, et al. 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. BMC Cancer. Published online December 13, 2022. doi:10.1186/s12885-022-10379-9