Real-world treatment patterns and outcomes with oral azacitidine maintenance therapy in patients with acute myeloid leukemia.

INTRODUCTION

This study describes baseline and clinical characteristics, treatment patterns, survival, and safety outcomes of patients with acute myeloid leukemia (AML) who received oral azacitidine (oral-AZA) maintenance therapy in Canada following its approval in 2021.

METHODS

A retrospective, observational medical record review was conducted of patients with AML in remission after induction therapy and who initiated treatment with oral-AZA between March 2021 and July 2023 in Canada. Real-world relapse-free survival and overall survival outcomes were estimated using Kaplan-Meier methodology.

RESULTS

Data from 119 patients were analyzed. The median age at oral-AZA initiation was 62.5 years. Most patients had favorable (39.5%) or intermediate (39.5%) genetic risk per the 2017/2022 European LeukemiaNet classification. Nearly all patients (99.2%) received cytarabine-based induction regimens. A total of 55.5% of patients received consolidation therapy, with a median of two cycles. After a median follow-up of 9.4 months, 68.1% of all patients were still receiving oral-AZA at last follow-up. After oral-AZA treatment, 21.0% of patients relapsed. Rates of real-world relapse-free survival and overall survival at 12 months from oral-AZA initiation were 66.9% and 74.5%, respectively. During oral-AZA treatment, 67.2% of patients experienced ≥1 adverse event. Concomitant antiemetic treatment was received by 78.2% of patients.

CONCLUSION

These findings provide real-world evidence further supporting the use of oral-AZA as a standard-of-care maintenance therapy in current routine clinical practice for patients with AML in remission who do not receive hematopoietic stem cell transplantation. These results may inform a broader clinical audience because of the inclusion of patients with diverse demographic and clinical characteristics.