Effects of azacitidine combined with venetoclax on inflammatory markers and overall response rate in elderly patients with newly diagnosed acute myeloid leukemia

This study aimed to evaluate the impact of azacitidine (AZA) combined with venetoclax (VEN) compared to AZA monotherapy on systemic inflammatory markers and the overall response rate (ORR) in elderly patients with newly-diagnosed acute myeloid leukemia (AML) who were unfit for intensive chemotherapy. A retrospective cohort study included 205 patients (≥ 60 years) treated between January 2021 and June 2022. Patients received either AZA alone ( n = 93) or AZA plus VEN ( n = 112). Serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) were measured at baseline and after three treatment cycles. ORR was assessed using International Working Group criteria. The combination therapy group showed significantly greater reductions in inflammatory markers (CRP, IL-6, TNF-α; all P < 0.001) and improved hematological recovery compared to monotherapy. ORR was higher with combination therapy (73.21% vs. 46.24%, P < 0.001). Baseline TNF-α > 70 pg/mL was independently associated with lower ORR (OR 0.589, P = 0.016). The incidence of adverse events did not differ significantly between groups. AZA plus VEN was associated with significantly greater reductions in systemic inflammation and improved treatment responses compared to AZA monotherapy in elderly AML patients, without a significant increase in severe toxicity. These findings suggest that the combination regimen may be a promising first-line option for this population; however, prospective randomized trials are warranted to confirm these observations.