Clinical observation of azacitidine combined with venetoclax in patients initially diagnosed with acute myeloid leukemia not suitable for intense chemotherapy

Objective To investigate the effectiveness and safety of azacitidine combined with venetoclax in the treatment of patients initially diagnosed with acute myeloid leukemia (AML) not suitable for intense chemotherapy.Methods A total of 35 patients initially diagnosed with AML who were admitted to Department of Hematology, the Affiliated Hospital of Xuzhou Medical University from February 2020 to June 2023, but not suitable for intensive chemotherapy were selected and their clinical data were retrospectively analyzed. All the patients were treated with azacitidine combined with venetoclax in the following regimen. Azacitidine was subcutaneously injected at 75 mg/m² on days 1-7, while the standard dose of venetoclax was 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-28, and the low dose of venetoclax was reduced to 400 mg on days 3-14. Then, their clinical effectiveness, survival and adverse reactions were analyzed.Results After one course of induction, the remission rate was 57.2% (20/35), where 9 patients obtained complete response (CR), 11 patients obtained complete remission with incomplete blood count recovery (Cri), and 14 patients obtained complete remission based on measurable residual disease (CRm). There were 10 patients less than 60 years old, with a CR/CRi ratio of 50%. The CR/CRi ratio of 23 patients with standard dose was 52.2% (12 cases), and that of 12 patients with small dose was 66.7% (8 cases), without statistical difference between the two groups (P>0.05). The median number of courses of treatment for all the patients was 2 (1-8), where 25 patients were treated for 1-2 courses, with a median overall survival (OS) of 12.3 (0.4-14) months, and 10 patients were treated for ≥ 3 courses, with a median OS of 12.6 (4-27.2) months, and there was statistical difference between the two groups (P=0.002). The main adverse reactions were hematological toxicity, followed by digestive system reactions, but most of which were tolerable.Conclusions Azacitidine combined with venetoclax is effective and well tolerated in the treatment of patients newly diagnosed with AML not suitable for intensive chemotherapy.