[Efficacy and Safety of Venetoclax-Based Chemotherapy Regimens for High-Risk Acute Myeloid Leukemia].
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OBJECTIVE: To evaluate the efficacy and safety of venetoclax (VEN) in combination with hypomethylating agents and/or low-dose cytarabine (LDAC) in patients with relapsed or refractory (RR) or persistently positive minimal residual disease (MRD) acute myeloid leukemia (AML). METHODS: RR or MRD persistently positive AML patients who received at least one cycle of VEN combined with hypomethylating agents (azacitidine/decitabine) and/or LDAC in the Fifth Medical Center of Chinese PLA General Hospital were retrospectively collected. The objective response rate (ORR), MRD negative conversion rate, relapse-free survival (RFS), overall survival (OS), and adverse events were observed, and efficacy and safety were analyzed. RESULTS: A total of 29 patients were included in this study, including 24 cases with RR AML and 5 cases with persistently positive MRD. In the RR AML group, the median age was 56 (16-74) years old, 13 patients achieved CR/CRi, and the MRD of 12 patients turned negative after treatment. In this group, the median follow-up time was 28.6 months, the median overall survival (OS) time was 11.9 months and the median relapse-free survival (RFS) time was 27.7 months. The 1-year cumulative OS rate was 48.1%, and the 1-year cumulative RFS rate was 61.5%. The most common adverse events were neutropenia and anemia, both of which occurred in 21 patients. In the group of MRD persistently positive AML, the median age was 49 (17-66) years old. Among them, the MRD of 4 patients turned negative. The median follow-up time was 31.4 months, and both the median OS and RFS time were not reached. The 1-year cumulative OS rate and 1-year cumulative RFS rate were both 80.0%. The most common adverse events were neutropenia, thrombocytopenia, and hypokalemia, all of which occurred in 2 patients. No death-related adverse events occurred. CONCLUSION: VEN combined with hypomethylating agents and/or LDAC shows good efficacy and safety in RR and MRD persistently positive AML patients, which provides a new possible treatment option for clinical practice.