Key clinical point: Oral azacitidine (OA) maintenance had a manageable safety profile in patients with newly diagnosed acute myeloid leukemia (AML) who attained the first complete remission (CR) or CR with incomplete blood count recovery (CRi) after induction chemotherapy (IC). However, blood count monitoring for at least the first 2 treatment cycles is recommended.
Major finding: Gastrointestinal (91% vs. 62%) and hematologic (66% vs. 47%) adverse events were common with OA vs. placebo. Adverse events were mostly manageable with dose interruptions (43%) or reductions (16%) and infrequently led to OA discontinuation (13%).
Study details: This safety analysis of the QUAZAR AML-001 trial included 469 patients with newly diagnosed AML with intermediate- or poor-risk cytogenetics who attained the first CR/CRi after IC, randomly assigned to receive either 300 mg OA (n = 236) or placebo (n = 233).
Disclosures: This study was funded by Celgene, a Bristol Myers Squibb Company. Some investigators, including the lead author, reported ties with various pharmaceutical companies including Celgene and Bristol Myers Squibb.
Source: Ravandi F et al. J Hematol Oncol. 2021 Aug 28. doi: 10.1186/s13045-021-01142-x .