Dr Hamilton on HRQOL Differences With Gilteritinib Vs Placebo in Post-Transplant FLT3-ITD+ AML

Betty Hamilton, MD, medical oncologist, Department of Hematology and Medical Oncology, Cleveland Clinic, sheds light on health-related quality of life (HRQOL) differences between post-transplant treatment with gilteritinib (Xospata) vs placebo in patients with FLT3-ITD–positive acute myeloid leukemia (AML).

Investigators from the Blood and Marrow Transplant Clinical Trials Network launched a randomized, multicenter, phase 3 trial (NCT02997202) comparing gilteritinib with placebo following allogeneic hematopoietic cell transplantation (HCT) in patients diagnosed with FLT3-ITD–positive AML. The primary analysis, which assessed relapse-free survival (RFS), did not reveal statistically significant RFS differences achieved with each treatment, though gilteritinib was associated with higher rates of treatment-emergent adverse effects (AEs).

However, in patients harboring detectable FLT3-ITD–positive measurable residual disease (MRD) peri-HCT, gilteritinib was linked to notably prolonged RFS, underscoring the efficacy of MRD monitoring and FLT3 inhibition in MRD-positive patients. The impact of gilteritinib maintenance on HRQOL remained unknown, prompting a prespecified exploratory analysis aimed at delineating the effect of gilteritinib vs placebo on HRQOL.

Hamilton begins by stating that the investigation revealed no significant disparities in QOL between patients administered gilteritinib vs placebo. Various HRQOL measures, including the Functional Assessment of Cancer Therapy (FACT)–Bone Marrow Transplant, FACT-Leukemia, and EUROQoL, were employed, the latter being an international HRQOL metric, she explains. Across all domains, no significant discrepancies in QOL emerged between gilteritinib and placebo recipients, Hamilton says. Notably, post-transplant HRQOL improved over time, a finding which was consistent with those from other studies, she elucidates.

Specifically, an inquiry into treatment tolerability, assessing whether patients were bothered by AEs, revealed no discernible differences between the gilteritinib and placebo groups, she continues. In patients receiving transplant, who are typically treated and monitored by transplant centers, prioritization of treatment perspectives and patient-reported outcomes regarding QOL remains crucial, Hamilton adds. Additionally, the significance of these maintenance therapies is underscored by mounting evidence supporting their use, as they enhance survival and are well tolerated, she concludes.