Outpatient Versus Inpatient Azacitidine Plus Venetoclax Regimen in Elderly Acute Myeloid Leukemia: A Multicenter Retrospective Analysis

Objectives: Azacitidine (AZA) combined with venetoclax (VEN) as an outpatient treatment of unfit patients with acute myeloid leukemia (AML) has been infrequently investigated. Methods: We report on 65 elderly AML patients: 35 patients received AZA + VEN as first-line and 30 after progression on prior treatment with AZA (R/R group). Thirty-eight patients were treated as outpatients, while 27 were hospitalized. The overall survival (OS) and event-free survival (EFS) were calculated, and predictive factors were assessed using Cox regression models. Results: Inpatients were slightly younger, with a median age of 72 versus 74 years in outpatients (p = 0.015). Median WBC was higher in inpatients (median 7.3 × 109/L vs. 2.9 × 109/L, p = 0.020). Median marrow blast count was 43% in inpatients versus 25.5% in outpatients (p = 0.042). Treatment setting emerged as a key predictive factor for infection development during Cycle 1 in both univariate (p = 0.016) and multivariate analysis (p = 0.043), in the overall cohort. Inpatients had a significantly higher infection rate (81.4%) versus outpatients (44.7%, p = 0.004). In R/R group, 1-year EFS was 68% for outpatients versus 38% for inpatients (p = 0.009). One-year OS was 77% in outpatients versus 38% in inpatients (p = 0.052). Conclusions: In most instances, outpatient administration of Cycle 1 of AZA + VEN should be preferred as a beneficial option.