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• W4379016175 abstract "Abstract Purpose Relapsed/refractory acute myeloid leukemia (R/R AML) has a low remission rate and poor prognosis, and the current therapeutic measures are limited and low in effectiveness. This clinical study investigated the efficacy and safety of the Bcl-2 inhibitor venetoclax (VEN) used in combination with the DCAG regimen (decitabine/azacytidine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor) in the treatment of R/R AML. Methods We analyzed the clinical data of R/R AML patients who received the VEN-DCAG regimen at the First Medical Center of the PLA General Hospital from 3/2021 to 1/2023. Postmedication responses were observed and analyzed, including CR/CRi (complete remission/complete remission with incomplete hematological recovery) rate, measurable residual disease (MRD) negative rate (patients achieving CR/CRi), overall survival (OS), event-free survival (EFS), and success rate of subsequent bridging allogeneic hematopoietic stem cell transplant (allo-HSCT). Results Twenty patients treated with VEN + DCAG for R/R AML were included. The median age was 40 (10–70) years, 11 (55%) were male and 9 (45%) were female. The ORR was 90% (18/20) after the 1st cycle of treatment, with 17 (85%) CR/CRi (10 MRD negative) patients, 1 (5%) PR, and 2 (10%) NR patients. Twelve patients (7 MRD- CR, 4 MRD + CR, 1 NR) were treated with the subsequent VEN-DCAG regimen, 3 cases MRD turned negative (1 course of MRD + CR), 1 NR patient died of disease progression after receiving the subsequent VEN-DCAG, and 13 patients eventually achieved MRD- CR (76.5%). Among them, there were 7 patients in the relapse group, 7 with CR/CRi and 6 with MRD-negative CR (85.7%); there were 13 patients in the refractory group, 10 with CR/Cri and 7 with MRD-negative CR (70%). The treatment response rates were 100% (7/7) and 84.6% (11/13) for patients in the relapse and refractory groups, respectively. All patients experienced varying degrees of adverse events (AEs), with hematologic AEs (mainly myelosuppression) and nonhematologic AEs (with fever, gastrointestinal discomfort and infection being more common). At the last follow-up, 1 (MRD + CR) of 11 patients (7 MRD- CR, 4 MRD + CR) who received allo-HSCT died; 5 (2 MRD- CR, 1 PR, 2 NR) of 9 patients (6 MRD- CR, 1 PR, 2 NR) who were not treated with allo-HSCT died. The median follow-up time was 12.7 (2.6–21.8) months for the 14 surviving patients. The median OS was 4.35 (0.7–18.1) months for the 6 patients who died. CONCLUSION VEN-DCAG is an effective treatment regimen for R/R AML patients, with high rates of complete remission and good tolerability in both relapsed and refractory AML patients. The rate of MRD-negative CR can be further improved by increasing the number of courses of treatment in patients with MRD-positive CR. Allo-HSCT should be bridged as soon as possible after achieving CR by VEN-DCAG, which can significantly improve patient survival." @default.
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• W4379016175 date "2023-06-01" @default.
• W4379016175 modified "2023-10-16" @default.
• W4379016175 title "Venetoclax combined with hypomethylating agents and the CAG regimen (DCAG) in relapsed/refractory AML: A single- center clinical trial" @default.
• W4379016175 doi "https://doi.org/10.21203/rs.3.rs-2996129/v1" @default.
• W4379016175 hasPublicationYear "2023" @default.
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