Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo

Abstract

BackgroundIn this analysis we report patients with advanced gastrointestinal stromal tumors (GIST) refractory to imatinib and sunitinib therapy as derived from the EuroQol-5D (EQ-5D) for progression-free (PF) and progressive disease health status.MethodsData were analyzed from a phase III trial conducted at 57 hospitals in 17 countries (trial registration number, NCT01271712). Patients with advanced GIST were randomized (2:1) to receive blinded treatment using oral regorafenib 160 mg daily or placebo, plus best supportive care (BSC) in both groups, for the first 3 weeks of each 4-week cycle. EQ-5D-3L was administered on day 1 of each cycle before contact with their physician and before any study-related procedures. The effect of disease progression on the utility of EQ-5D was tested with paired-samples comparison and general linear mixed modeling (GLMM).ResultsOne hundred and eighty five patients [93 % of the intention-to-treat (ITT) population] completed 803 EQ-5D questionnaires: 77.7 % in progression-free (PF) state, 6.5 % at progression, 13.9 % following first progression, and 1.9 % after second progression. Mean baseline utility was 0.767 (SD 0.221) with no significant between-group differences for active treatment and BSC. The first post-progression health state was 0.647 (SD 0.343), suggesting significantly impaired health-related quality of life after confirmed disease progression showed a decrease of −0.120 (paired samples t test, p = 0.001). GLMM showed no effect of study treatment or cycle number on utility.ConclusionsWe demonstrate a significant and clinically meaningful difference in health state utility values between PF and progression. Utility values remained stable over successive regorafenib cycles after controlling for disease status and treatment type.

Efficacy and safety of regorafenib in Korean patients with advanced gastrointestinal stromal tumor after failure of imatinib and sunitinib: A multicenter study based on the management access program.

“…The median OS was reported to be 17.4 months in this updated OS analysis of the GRID phase III trial [15], and 12.9 months in the current study. Furthermore, one study suggested that the quality of life was similar in patients with advanced GIST in both the regorafenib and placebo groups [16]. The present study population had similar treatmentrelated toxicity profiles to those of the previous phase II and phase III GRID trials but a lower incidence of hypertension and diarrhea (49% and 40% in GRID trial vs. 28% and 25% in this study) [11,12].…”

Efficacy and Safety of Regorafenib in Korean Patients with Advanced Gastrointestinal Stromal Tumor after Failure of Imatinib and Sunitinib: A Multicenter Study Based on the Management Access Program

“…The median OS was reported to be 17.4 months in this updated OS analysis of the GRID phase III trial [ 15 ], and 12.9 months in the current study. Furthermore, one study suggested that the quality of life was similar in patients with advanced GIST in both the regorafenib and placebo groups [ 16 ].…”

Optimizing the dose in patients treated with imatinib as first line treatment for gastrointestinal stromal tumours: A cost‐effectiveness study

“…Sunitinib utility score was based on an article by Paz‐Ares et al which gathered EQ‐5D scores of a phase III clinical study comparing GIST‐patients treated with sunitinib and a placebo. Regorafenib utility scores were based on EQ‐5D scores determined by the GRID study, a phase III trial reporting on the efficacy and safety of regorafenib as treatment for advanced GIST.…”