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Impact of 10-day decitabine vs standard intensive chemotherapy on HRQoL in older patients with AML
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The phase III European Organization for Research and Treatment of Cancer (EORTC)-1301 AML21 trial (NCT02172872) assessed the safety and efficacy of 10-day decitabine vs standard 3+7 intensive chemotherapy in newly diagnosed, fit patients aged ≥60 years with acute myeloid leukemia (AML).1 The study design and primary results from this trial were reported previously by the AML Hub. This trial included health-related quality of life (HRQoL) as a secondary endpoint, and results from the HRQoL analysis were published in Blood by Efficace, et al.1 |
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At 2 months, treatment with 10-day decitabine resulted in a lower risk of HRQoL deterioration compared with intensive chemotherapy (76% vs 88%; odds ratio, 0.43; 95% confidence interval, 0.24–0.76; p = 0.003). |
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There were no statistically significant differences in the risk of HRQoL deterioration between decitabine and intensive chemotherapy after 6 or 12 months, suggesting both treatments have comparable long-term impacts on quality of life. |
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Patients in the 3+7 arm who underwent allogeneic hematopoietic stem cell transplantation experienced clinically meaningful deterioration post-transplantation, relative to baseline, in the physical functioning, role functioning, fatigue, and burden of illness scales. In contrast, no clinically meaningful deteriorations were observed post-transplantation in the decitabine arm. |
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When combined with the efficacy and safety results of this trial, the HRQoL findings suggest that decitabine may be preferable over intensive chemotherapy for newly diagnosed, older, fit patients with AML. |
- Efficace F, Kicinski M, Coens C, et al. Decitabine in older patients with AML: Quality of life results of the EORTC-GIMEMA-GMDS-SG randomized phase 3 trial. Blood. 2024;144(5):541-551. DOI: 10.1182/blood.2023023625
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