Betty Hamilton, MD, discusses quality of life differences between post-transplant gilteritinib vs placebo in FLT3-ITD–positive acute myeloid leukemia.

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 

-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 

-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 

-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.

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

Betty Hamilton, MD, associate staff physician, Department of Hematologic Oncology and Blood Disorders and Blood and Marrow Transplant Program, discusses the prognostic impact of molecular mutations in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) on allogeneic hematopoietic cell transplant (HCT) outcomes and the adverse impact of 

In a study, next-generation sequencing was used in 123 patients to evaluate the most commonly recurring mutations in MDS and AML, and what their prognostic impacts were on outcomes after HCT, Hamilton explains.

 mutations were reported to be a predictor for poor survival following HCT. In addition, the presence of complex karyotype, 

 mutations is also associated with poor overall and relapse-free survival. Analyses are ongoing to validate these findings and consider other factors, Hamilton adds.

Betty Hamilton, MD, associate staff physician, Department of Hematologic Oncology and Blood Disorders and Blood and Marrow Transplant Program, discusses the prognostic impact of molecular mutations in acute myeloid leukemia and myelodysplastic syndromes on allogeneic hematopoietic cell transplant outcomes and the adverse impact of TET2 mutations.


Betty Hamilton, MD

Articles

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

Dr. Hamilton on Prognostic Impact of Molecular Mutations in AML and MDS on HCT Outcomes