Evaluating Quality of Life Post HCT in Patients With AML

Betty Hamilton, MD

Patient-reported outcomes, especially on health-related quality of life (QOL), are important points of investigation in clinical trials. Researchers at Cleveland Clinic, including Betty Hamilton, MD, sought to look at the effect of gilteritinib (Xospata) on health-related QOL in patients with FLT3 internal tandem duplication(ITD)-positive acute myeloid leukemia (AML) who underwent an allogeneic stem cell transplant.

Hamilton, associate professor of medicine at Cleveland Clinic, presented the study at the 2024 Transplantation and Cellular Therapy Tandem Meetings and noted that gilteritinib did not affect health-related QOL compared with placebo, and both patient groups reported improved QOL over time after transplant, regardless of treatment.

Further, while more adverse events were associated with gilteritinib, patients’ perceptions of these adverse events were not worsened. However, it was observed that the main benefit of gilteritinib—increased relapse-free survival—was only seen in patients with detectable minimal residual disease after transplant, highlighting the importance of ongoing monitoring.

In an interview with Targeted Oncology^TM, Hamilton discussed the study, its findings, and its implications for clinical trial design and practicing clinicians.

Targeted Oncology: What was the background or rationale for this study?

Hamilton: My abstract is a quality –of life analysis on the Blood and Marrow Transplant Clinical Trials Network 1506. This was a randomized trial comparing posttransplant maintenance with gilteritinibvs placebo in patients with FLT3 ITD[-positive] acute myeloid leukemia. This was a predefined exploratory analysis to evaluate the quality of life of patients receiving maintenance therapy.

What are some of the unmet needs in this space?

Patient-reported outcomes are the measure of a patient's quality of life from the patient perspective [and are] increasingly recognized as something that is essential to incorporate into clinical trials. They are now recognized as important end points in trials because it is important to know the patient’s perspective and what they see as toxicities and [adverse] effects from treatment.

Can you summarize your findings?

We found no significant differences in quality of life between patients receiving gilteritinib vs placebo. We used several health-related quality of life measures including the FACT-BMT, the FACT-Leukemia and the European [Quality of Life Index], which was an international health-related quality of life measure. Across all domains, there were no significant differences in quality of life between patients who received gilteritinib vs placebo.

We did find that health-related quality of life did improve over time posttransplant, consistent with other studies. Specifically, there was a question that was investigated that evaluated treatment tolerability—whether a patient was bothered by [adverse] effects, and there was no difference in responses to that either between the gilteritinib and placebo [groups].

Are there any takeaways for a community oncologist?

In the transplant population, this is a cohort that is often cared for and followed by a transplant center. However, it is important to note that getting the patient's perspective and patient-reported outcomes and quality of life is important, and that these maintenance therapies are big. There [are] increasing data to support their use, and can not only improve survival, but also shows that [the agents are] well-tolerated.

REFERENCE:

Hamilton B, Levis M, Elsouda D, et al. Health-related quality of life with gilteritinib versus placebo post-transplant maintenance for FLT3-ITD+ acute myeloid leukemia (AML): a quality of life analysis from BMT CTN 1506. Presented at: 2024 Transplantation and Cellular Therapy Tandem Meetings. February 21-24, 2024. San Antonio, TX. Abstract 51.