Oral Azacitidine After Achieving Remission in AML Improves Survival and Does Not Worsen Quality of Life
Orally administered azacitidine as maintenance therapy in patients with acute myeloid leukemia (AML) after achieving remission provides a favorable effect in terms of fatigue and improving health-related quality of life (HRQoL). This is based on the results of the QUAZAR AML-001 study, which were published in the journal Haematologica.
QUAZAR AML-001 Study Methodology
This phase III placebo-controlled study showed that oral azacitidine significantly prolonged both overall survival (OS) compared to placebo (median of 24.7 vs. 14.8 months from randomization; p = 0.0009) and relapse-free survival (RFS: 10.2 vs. 4.8 months; p = 0.0001). The treatment was associated with manageable adverse events.
The study focused on patients aged ≥ 55 years with intermediate or adverse cytogenetic risk and an ECOG performance status (PS) ≤ 3, who were also not eligible for transplantation. Participants were randomized to receive oral azacitidine at a dose of 300 mg daily or placebo in 14-day/28-day cycles during 4 months after achieving the first complete remission (CR) or CR with incomplete hematologic recovery.
Substudy on Fatigue and Quality of Life
Ideally, maintenance therapy should improve survival without worsening the quality of life of patients. Therefore, the impact of oral azacitidine on fatigue and HRQoL was examined as a secondary goal of the study. The Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires, specifically the fatigue scale, and the EuroQoL EQ-5D-3L were utilized. Researchers evaluated whether azacitidine administration compared to placebo did not worsen assessed variables compared to the pre-treatment period.
No clinically significant differences were observed between the average changes in FACIT fatigue scores or the EQ-5D-3L Health Utility Index (HUI) across the treatment arms compared to baseline. The analysis confirmed the noninferiority of oral azacitidine compared to placebo. Sustained quality of life was also observed in subgroup analyses based on patient age, cytogenetic risk, or PS.
Conclusion
The QUAZAR AML-001 study concludes that oral azacitidine therapy significantly improves both OS and RFS in patients without contributing to worsening of fatigue or overall quality of life for those in remission. Oral azacitidine also offers additional potential benefits such as convenient administration and reduced healthcare visits, making it a suitable modality for AML maintenance therapy.
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Source: Roboz G. J., Döhner H., Pocock C. et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase III, placebo-controlled QUAZAR AML-001 trial. Haematologica 2021; 106 (12): 3240–3244, doi: 10.3324/haematol.2021.279174.
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2011-CZ-2300023
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