Abstract
BACKGROUND: Venetoclax and hypomethylating agents (HMA+VEN), initiated in inpatient or outpatient, is the standard treatment for many older adults (≥60 years) with acute myeloid leukemia (AML). However, little is known about the patient experience of receipt of this regimen in older adults with AML, specifically on their changes in symptoms, function and quality of life (QOL). Hence, this study aims to explore changes in symptoms, function, and QOL during cycle 1 and cycle 2 of HMA+VEN.
METHODS: This was a preliminary analysis of the control group of an ongoing clinical trial (NCT04570709). Assessments were conducted at cycle 1 and cycle 2 of HMA+VEN. Nineteen AML specific symptoms were measured with the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE), performance status was assessed using the Clinician-reported Karnofsky Performance Scale (KPS), function and QOL were measured with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Descriptive analysis was performed. Specifically, mean±standard deviation was calculated for the KPS and the QLQ-C30; percentage was calculated for the PRO-CTCAE.
RESULTS: A total of 20 (cycle 1) and 15 (cycle 2) participants completed assessments, with an attrition rate of 25%. Attrition reasons included death (n=2) and consent withdrawal due to feeling overwhelmed (n=3). Fifteen out of 20 participants were treated in the outpatient infusion clinic at cycle 1 and all participants received outpatient treatment at cycle 2. Twenty participants (cycle 1) and 14 participants (cycle 2) received treatment at the same institution for both cycles; 1 participant received cycle 2 treatment at their local oncology practice. The mean sample age was 74.65±7.5 (range 64-89 years). Most patients were male (75%), non-Hispanic White (85%), high-school graduate/GED or above (95%), married/partnered (70%), and living with others (65%). Performance status remained stable with 86±18.5 at cycle 1 and 85.48±15.8 at cycle 2. However, between cycles, the score of each function scales (physical: 72.3±22.6, 76.9±18.0; role: 56.7±33.9, 65.6±21.3; emotional: 83.3±15.3, 86.7±10.8; cognitive: 77.5±26.1, 87.8±16.0; social: 60±28.8,75.6±23.5) and overall QOL (55.8±22.6, 64.4±16.8) from the QLQ-C30 increased from cycle 1 to cycle 2. Fatigue was the worst reported symptom (49.4±29.8, 39.3±17.2) among the QLQ-C30 symptoms; 80% and 73% of the sample reported "mild” to "very severe” fatigue/tiredness/lack of energy using the PRO-CTCAE at cycle 1 and cycle 2, respectively. Specifically, among the patients having fatigue symptom, "severe” to "very severe” fatigue/tiredness/lack of energy was only reported at cycle 1 (severe: 15%, 0%; very severe: 10%, 0%); while "mild” to "moderate” fatigue/tiredness/lack of energy was reported at both cycle 1 and cycle 2 (mild: 25%, 40%; moderate: 30%, 33%).
CONCLUSION: The high severity and prevalence of fatigue highlight the necessity of exploring early interventions at the initiation of cycles to manage symptom and mitigate functional decline. Quality of life increases between cycles may be attributable to the understanding of AML process and initiation of chemotherapy. Further exploration of care settings (inpatient vs outpatient, cancer center vs local oncology practice) at each cycle is needed. Future AML studies warrant an increased female, black, indigenous, and people of color samples to better understand symptom, function, and QOL changes between cycles 1 and 2 of HMA+VEN.
Disclosures
Pergolotti:Select Medical: Current Employment. Foster:Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; LOXO Oncology: Research Funding; Macrogenics: Research Funding; Newave Pharmaceuticals: Research Funding; Rafael Pharmaceuticals: Research Funding; Zentalis Pharmaceuticals: Consultancy; Bellicum Pharmaceuticals: Research Funding. Bryant:Carevive Systems, Inc: Research Funding.
Author notes
Asterisk with author names denotes non-ASH members.
