Background/rationale: Acute myeloid leukaemia (AML) is an aggressive haematological malignancy arising from malignant transformation of myeloid precursor cells. Incidence rises above age 65 and is associated with poorer survival. Active management options now include less toxic cytotoxic regimens such as azacitadine/venetoclax. There is limited data on quality of life (QoL) in older adults with AML receiving newer treatments, thus we aimed to assess this with the goal of using this information to guide future treatment discussions. However, several challenges were encountered affecting study conduct.
Methods: This prospective, longitudinal feasibility study included patients aged >70 with newly diagnosed AML. They were assigned to one of three treatment cohorts: anthracycline based chemotherapy, azacitadine/venetoclax and supportive management with target of n=10. QoL was assessed using Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) pre-treatment, and 3, 6, 9 and 12 months post-diagnosis. Planned statistical analyses would focus on mean change from baseline at each timepoint, and inter-cohort comparisons.
Impact on practice: Recruitment began in February 2024. Fourteen eligible patients were identified, but only three patients were enrolled: one completed all questionnaires, and two completed baseline FACT-Leu but either died or were lost to follow-up. Other reasons for ineligibility included: screen failure due to acute clinical deterioration (n=2), lack of in-language questionnaires (n=2), cognitive impairment (n=3) and declined (n=2). Due to poor recruitment, the study is planned to close in January 2026.
Discussion: This study highlights the challenges in conducting longitudinal QoL research in older adults with acute haematological malignancies, including high early mortality rates and cognitive impairment. Geriatric-specific considerations such as frailty and functional status impacted eligibility and engagement with current study. Though limited by small numbers, this study reinforces the urgent need for research methodologies that are inclusively grounded in the realities of treating older adults with AML.