PROs from the phase III QuANTUM‑First trial of quizartinib in ND FLT3‑ITD AML

Results from an exploratory analysis of patient-reported outcomes (PROs) in the global, randomized, placebo-controlled, phase III QuANTUM‑First (NCT02668653) study, which evaluated the addition of quizartinib to standard chemotherapy vs placebo in adults with newly diagnosed (ND) FLT3-internal tandem duplication (FLT3‑ITD) acute myeloid leukemia (AML), were published in The Lancet Haematology by Olíva et al. 

Key data: Baseline PRO scores were similar between treatment groups (quizaritinib, n = 254; placebo, n = 255). At a median follow-up of 39.2 months, the mean change in global health status and quality of life (GHS‑QoL) score from baseline was above the minimal clinically important difference in both treatment groups from consolidation onwards. There was no significant difference in GHS‑QoL change from baseline between treatment groups, with a mean treatment difference (quizartinib minus placebo) of −2.0 (95% confidence interval [CI], −4.8 to 0.7; p = 0.15). The time to sustained improvement in GHS‑QoL was similar between groups (sub-distribution hazard ratio [SHR], 1.126; 95% CI, 0.904–1.403; p = 0.28), as was time to definitive deterioration of GHS‑QoL (hazard ratio [HR], 0.81; 95% CI, 0.51–1.28; nominal p = 0.37). 

Key learning: The addition of quizartinib to standard chemotherapy does not adversely affect health-related quality of life (HRQoL), supporting its use across induction, consolidation, and maintenance treatment of ND FLT3‑ITD AML. 

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