ABSTRACT 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 × 10 9 /L vs. 2.9 × 10 9 /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.
Kasmi et al. (Sun,) studied this question.