Venetoclax plus decitabine, cytarabine, aclarubicin, and G‐ CSF in adults with newly diagnosed acute myeloid leukemia: A multicenter, retrospective study

This multicenter, retrospective study evaluated the efficacy and safety of the venetoclax plus decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (VD-CAG) regimen in newly diagnosed acute myeloid leukemia (ND-AML) patients aged 18-60. The analysis included, but was not limited to, the composite complete response (CRc) rate, measurable residual disease (MRD) negativity rate, overall survival (OS), event-free survival (EFS), and safety. A total of 107 adult patients with AML were included in the study, conducted between March 1, 2022, and December 31, 2024. The median age was 49 years (range: 18-60 years), with a male-to-female ratio of 44:63. The CRc rate after one cycle of the VD-CAG regimen was 86.9% (95% CI 79-92.7; 93 of 107 patients) in the entire cohort. 73 (79%) of 93 patients who reached CRc had undetectable MRD. Grade 3 or worse adverse events included neutropenia in 107 (100%) of 107 patients, thrombocytopenia in 107 (100%), anemia in 107 (100%), febrile neutropenia in 57 (53%), pneumonia in 10 (9.3%), sepsis in five (4.7%), and tumor lysis syndrome in three (2.8%). No treatment-related deaths occurred. With a median follow-up of 8.8 months (range: 1-33.5 months), the median EFS and OS are not reached. The estimated 12-month OS was 90% (95% CI 90-95) and 12-month EFS was 79% (95% CI 69-87). The VD-CAG regimen represents an effective induction therapy for young ND-AML. It leads to high rates of CRc and MRD-negative remissions, along with encouraging OS and EFS across prognostic subgroups.