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.