Real-life data of azacitidine-venetoclax combination in acute myeloid leukemia patients: a single center experience

Abstract

Aims: To evaluate real-life data on the efficacy and safety of Venetoclax (Ven) therapy used in combination with hypomethylating agent (HMA) in patients with acute myeloid leukemia (AML). Methods: The records of newly diagnosed, relapsed or refractory (RR) AML patients over 18 years of age who were planned to be treated with Azacitidine (AZA) combined with Ven because they were not suitable for intensive chemotherapy and patients who received AZA combined with Ven maintenance therapy after achieving remission were retrospectively analyzed. The standard protocol for patients is subcutaneous or intravenous AZA 75 mg/m2 on days 1-7/ every 28 days + oral Ven treatment 100-400 mg/day for 28 days. The treatment response rates, survival times, and side effect profiles of 18 newly diagnosed patients, 12 RR patients, and 4 patients receiving AZA+Ven as maintenance treatment between January 2021 and March 2022 were evaluated. Results: It was found that 8 of the 34 patients (23.5%) who were examined in the present study died before the first response could be evaluated. When the response rates were evaluated, complete response (CR) or complete remission with incomplete blood count recovery (CRi) (CR+CRi) was found to be 61% in the group receiving AZA+Ven in the first line, and CR+CRi was 50% in the group receiving AZA+Ven because of RR AML. In the group receiving AZA+Ven in the first line, the average Overall Survival (OS) was 8.00 months (95% CI: 1.58-14.41), and 7.00 months in the RR group (95% CI: 1.78-12, 21). All patients in the group receiving AZA+Ven for maintenance purposes were alive and the median follow-up period was 12.50±6.02 months in this group (Mean±SD). The most common side effect was neutropenia, and the most common cause of death was disease progression. Conclusion: In AML patients ineligible for intensive treatment due to advanced age or comorbidities, real-life data of AZA+Ven therapy with effective CR+CRi rates and a manageable spectrum of side effects promise hope.