Analysis of the QuANTUM-First phase 3 trial found that the impact of quizartinib on patient-reported outcomes and health-related quality of life (QoL) were equivalent to a placebo, based on the European Organisation for Research and Treatment of Cancer 30-item Core QoL Questionnaire. The results were reported in The Lancet Haematology in an article by a group of researchers led by Esther N. Olíva, MD, a senior consultant in the Department of Haematology at London North West University Healthcare NHS Trust in the UK.
QuANTUM-First is a randomised phase 3 trial in individuals with newly diagnosed acute myeloid leukaemia that is FLT3 internal tandem duplication positive. Earlier analyses of the QuANTUM-First data showed a survival advantage for quizartinib versus placebo plus standard induction and consolidation chemotherapy with or without transplantation, followed by single-agent maintenance therapy.
Participants in the QuANTUM-First trial were randomly allocated (1:1) to quizartinib (40 mg/day) or placebo plus standard 7 + 3 induction chemotherapy, and then received standard consolidation chemotherapy with high-dose cytarabine plus quizartinib (40 mg/day) or placebo, allogeneic haematopoietic cell transplantation (allo-HCT), or both, followed by maintenance with single-agent quizartinib (30–60 mg/day) or placebo for up to 36 cycles. A total of 509 participants were included in the patient-reported outcome analysis set, 254 in the quizartinib group and 255 in the placebo group.
The overall median follow-up was 39.2 months. Baseline patient-reported outcome scores were similar between groups. The change in global health status and QoL score (GHS–QoL) from baseline was above the minimal clinically important difference from consolidation onwards in both groups. The treatment difference (quizartinib minus placebo) in change from baseline for GHS–QoL (by mixed-effects model for repeated measures) was −2.0 (95% CI, −4.8 to 0.7, nominal P=0.15), indicating no substantial difference between groups, further confirmed by time to sustained improvement (subdistribution hazard ratio 1.126 [95% CI, 0.904 to 1.403], nominal P=0.28) and time until definitive deterioration (hazard ratio 0.81 [95% CI, 0.51 to 1.28], nominal P=0.37) analyses.
“The results indicate that quizartinib plus standard chemotherapy prolongs overall survival without adversely affecting patient-reported outcomes and health-related quality of life, with no substantial differences between groups,” the authors wrote. “Future research in real-world settings is warranted to assess the generalisability of these patient-reported outcome results.”
