Abstract Background: The treatment of older adults with acute myeloid leukemia (AML) is rapidly changing. Survival in this population has historically been dismal. However, optimism is growing with improved survival due, in part, to twelve new agents since 2017, including CPX-351 in 2017 for secondary AML in older adults. In addition, a major breakthrough in treating patients 75 and older emerged with the combination of azacitidine and venetoclax. These FDA approvals were based on improving survival. Quality of life data is essential to engage in a holistic and balanced discussion of the risks and benefits of treatment, whether with intensive treatment or non-intensive therapy. In this study QOL and survival are presented among patients aged 60 and older with newly diagnosed AML during the first 6 months of intensive versus non-intensive treatment. Methods: Following approval by the Scientific Review Committee and Institutional Review Board at Moffitt Cancer Center, a prospective observational study was conducted from July 2020 to April 2023. One hundred ninety older adults (aged 60+) with newly diagnosed AML completed the following quality of life (QOL) measures: Functional Assessment of Cancer Therapy-Leukemia version (FACTLeu), Memorial Symptom Assessment Short (MSAS), and the Brief Fatigue Inventory (BFI). One hundred patients received intensive treatment, and 90 received non-intensive treatment. QOL was assessed at baseline and on days 30, 60, 90, and 180 following enrollment. Survival was measured from the first day of treatment until the date of death or last follow-up through 2 years post-treatment. QOL measures were evaluated at each follow-up time point using general linear models. Patient and disease characteristics that differed by treatment group were included in the model as potential confounding factors, with the focus on treatment group differences. Alpha level was set at. 05 for the level of significance. Results: There were no significant treatment group differences in QOL at baseline. By Day 30, significant treatment group differences were found for fatigue, with averages of 42. 3 (SD=23. 23) and 32. 9 (SD=24. 14) for the non-intensive (n=65) and intensive (n=88) groups, respectively (p=0. 011). The Global Distress Index (GDI) was significantly different between groups, with averages of 13. 7 (SD=7. 07) and 11. 3 (SD=7. 53, p=. 042). These results suggest the non-intensive group had worse QOL on Day 30. On Day 60, four of the QOL measures differed significantly by group. The average BFI was 36. 9 for the non-intensive group (n=59) and 25. 7 for the intensive group (n=85), p=. 0021. For the MSAS -physical score, the non-intensive group had a mean score of 12. 1, and the intensive group had a mean score of 8. 8, p=0. 190, indicating a better physical QOL score for the intensive group. MSAS GDI score for the non-intensive group was 12. 5 and 9. 8 for the intensive, p =. 042. The FACT-physical subscale mean score for the non-intensive group was 20. 5, and 22. 5 for the intensive group, p=0. 334. Higher scores indicate better physical QOL. No statistically significant differences were observed on Days 90 and 180 with 57 and 42 non-intensive and 81 and 73 intensive patients, respectively. Survival analysis was performed using the Kaplan-Meier method between the treatment groups. Median overall survival for the intensive group was 19. 3 months, and 9. 1 months for the non-intensive group (log-rank P: 0. 009). Conclusion: Evaluating QOL and survival can improve understanding of the patient's journey with different treatment intensities for older adults with AML. Baseline QOL was similar between groups. On Day 30, the intensive group had better QOL in terms of fatigue and global distress, and this persisted at Day 60, with additional physical QOL differences between groups. This suggests that group differences are attributed to the intensity of treatment. This information allows for a more balanced discussion of the risks and benefits from patient-reported data captured prospectively.
Sallman et al. (Mon,) studied this question.
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