Comparison of Pre-Treatment Sociodemographic and Clinical Characteristics, Symptoms, and Quality of Life Among Older Patients with AML Who Received Intensive Versus Non-Intensive Therapy

Background: There are limited data regarding the symptom burden and quality of life (QOL) experienced by older patients (>= 60 years) with AML receiving intensive and non-intensive chemotherapy. The long-term goal of this study is to provide holistic information to patients and their medical teams to help them meet their treatment goals. This can be achieved by incorporating disease and patient factors found to moderate QOL, allowing patients to align their treatment choices with their preferences. As part of a larger study, our team aimed to evaluate the sociodemographic, clinical characteristics, and prevalence of QOL and symptoms experienced among newly diagnosed older patients with AML within 7 days of initiating therapy with intensive or non-intensive chemotherapy.

Methods: Newly diagnosed older patients with AML were recruited from July 8, 2020, to April 2023. Inclusion criteria: Patients ≥ 60 years of age with newly diagnosed, pathology-confirmed AML, within 7 days of starting treatment, can read and speak English at the 8th-grade level.

Baseline assessments (within 7 days of initiating therapy) included: 1) Functional Assessment of Cancer Therapy-Leukemia version (FACT-Leu); 2) Memorial Symptom Assessment Short-Form (MSAS-SF); 3) Brief Fatigue Inventory (BFI); 4) Hematopoietic cell transplantation-specific comorbidity index (HCT-CI); and 5) Clinical Frailty Scale. Per normal practice, all patients were classified by the European LeukemiaNET 2017 cytogenetic risk category: favorable, intermediate, and poor. Demographics and clinical treatment data were obtained by chart review and interviews with participants. Comparison data for sociodemographic, clinical characteristics, symptoms, and QOL were analyzed using descriptive statistics, including mean, standard deviation, median, and range for continuous measures, and proportions and frequencies for categorical measures. Differences between groups were determined using p-values for continuous measures with t-tests and Fisher's exact tests for categorical measures.

Results: Among 206 consented patients, 190 completed assessments (100 patients in the intensive and 90 in the non-intensive groups). The groups differed significantly by age (intensive 67.5 vs. 74, p <0.001). Both groups were predominantly male (71% vs. 59%); most patients were White (89%), 3% non-non-Hispanic Black, and 1% Chinese. Patients receiving intensive chemotherapy were more likely to complete high school and some college (96% vs. 86%, P= 0.029) and had more favorable risk cytogenetics (18.2% vs. 4.4%, P=0.013). Most patients in the intensive (60.6%) and non-intensive groups (67.8%) had poor risk cytogenetics. Patients receiving intensive chemotherapy were also less likely to be frail (33% vs. 56.6%, P=0.013), to have cerebrovascular disease (2% vs. 8.9%, P=0.049), pulmonary comorbidities (38% vs. 43%, P=0.024), or valvular disease (0% vs. 6.7%, P=0.011)

Related to symptoms, fatigue was similar between the groups, with the majority experiencing moderate fatigue (score of 4-6/10 on the BFI). The most common and distressing symptoms on the MSAS-SF were similar between the groups, including lack of energy (82-85%), worrying (60-66%), feeling sad (50%-61%), feeling drowsy (57.8% -59%), and difficulty sleeping (54.4%-58%). The prevalence of symptoms did not differ between treatment groups at baseline. There were no significant differences in QOL as measured by FACT-Leu at baseline between the two groups.

Conclusions: In this study of 190 older patients with newly diagnosed AML, treatment groups differed in age, cytogenetic risk category, and frailty at baseline. They also differed in level of education, with the more formal education in the patients treated intensively. QOL and symptoms were similar. Baseline assessments of disease and patient factors, including QOL and symptoms, provide a point of reference for evaluating response to treatment. Future longitudinal results of QOL, symptoms, and survival between treatment intensities will provide evidence to strengthen shared decision-making, focusing on aligning treatment with patient preferences.

Kuykendall:Incyte: Honoraria; PharmaEssentia: Honoraria; Protagonist Therapeutics: Honoraria, Research Funding; Novartis: Research Funding. Chan:Jazz: Research Funding; Aptitude Health: Honoraria; Novartis: Honoraria; Abbvie: Honoraria, Research Funding; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Syndax: Membership on an entity's Board of Directors or advisory committees. El-Jawahri:GSK: Consultancy; Novartis: Consultancy; Tuesday Health: Consultancy; Incyte: Consultancy. Sallman:Abbvie: Consultancy; Agios: Consultancy; Axiom: Consultancy; Gilead: Consultancy; Celyad: Consultancy; Froghorn: Consultancy; Incyte: Consultancy; Intellisphere, LLC: Consultancy; Johnson & Johnson: Consultancy; Kite: Consultancy, Membership on an entity's Board of Directors or advisory committees; Magenta Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; NextTech: Consultancy; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; AvenCell: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; BlueBird Bio: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Dark Blue Therapeutics: Membership on an entity's Board of Directors or advisory committees; Intellia: Membership on an entity's Board of Directors or advisory committees; Jasper Therapeutics: Membership on an entity's Board of Directors or advisory committees; NKARTA: Membership on an entity's Board of Directors or advisory committees; Orbital Therapeutics: Membership on an entity's Board of Directors or advisory committees; Rigel Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Shattuck Labs: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees; Syndax: Membership on an entity's Board of Directors or advisory committees; Syros: Membership on an entity's Board of Directors or advisory committees; Apera: Research Funding; Jazz: Research Funding. Komrokji:AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Geron: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Jazz Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; PharmaEssentia: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Rigel: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sobi: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sumitomo Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; DSI: Consultancy, Membership on an entity's Board of Directors or advisory committees; Servio: Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy; Keros: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; CTI biopharma: Membership on an entity's Board of Directors or advisory committees; DSI: Honoraria, Membership on an entity's Board of Directors or advisory committees; Servio: Honoraria; Taiho: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding. Lancet:Bristol Myers Squibb: Consultancy, Other: Consultant/Advisory Board; Prelude Therapeutics: Consultancy, Other: Bristol Myers Squibb; Tradewell Therapeutics: Consultancy, Other: Consultant/Advisory Board.