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• W3214560541 abstract "Abstract Background: Diagnosis of acute myeloid leukemia (AML) is associated with poor outcome in elderly and unfit patients. Recently, approval of the BCL-2 inhibitor Venetoclax (VEN) in combination with hypomethylating agents (HMA) led to a significant improvement of response rates and survival. Further, application in the relapsed or refractory (r/r) AML setting or in context of allogeneic stem cell transplantation (alloHSCT) seems feasible. Methods and Patients: Fifty-six consecutive adult AML patients on VEN from January 2019 to June 2021 were analyzed retrospectively. Patients received VEN either as first-line treatment, as subsequent therapy (r/r AML excluding prior alloHSCT), or at relapse after alloHSCT. VEN was administered orally in 28-day cycles either combined with HMA or low-dose cytarabine (LDAC). Results: After a median follow-up of 4.7 (range, 0.8 – 24.3) months median overall survival (OS) from start of VEN treatment was 13.3 (2.2 - 20.5) months, 5.0 (0.8 - 24.3) months and 4.0 (1.5 - 22.1) months for first-line, subsequent line treatment and at relapse post-alloHSCT, respectively. Median OS was 11.5 (10 - 22.3) months from start of VEN when subsequent alloHSCT was carried out. Overall response rate (composite complete remission + partial remission) was 51.8% for the total cohort (61.1% for VEN first-line treatment, 52.2% for subsequent line and 42.8% at relapse post-alloHSCT). Subgroup analysis revealed a significantly reduced median OS in FLT3-ITD mutated AML with 3.4 (1.9 - 8.0) months versus 10.4 (0.8 - 24.3) months for non-mutated cases, (HR 3.59, 95% CI 0.94 - 13.72, p = 0.001). Patients harboring NPM1 or IDH1/2 mutations lacking parallel FLT3-ITD mutations showed a survival advantage over patients without those mutations (11.2 (5 - 24.3) months versus 5.0 (0.8 - 22.1) months, respectively, (HR 0.53, 95% CI 0.23 – 1.21, p = 0.131). The most common adverse events were hematological, with grade 3 and 4 neutropenia and thrombocytopenia reported in 44.6% and 14.5% of patients, respectively. Conclusion: Detailed analyses on efficacy for common clinical scenarios such as first-line treatment, subsequent therapy (r/r AML), and application prior to and post-alloHSCT are presented. The findings suggest VEN treatment combinations efficacious not only in first-line setting but also in r/r AML. Furthermore, VEN might play a role in a subgroup of patients with failure to conventional chemotherapy as a salvage regimen aiming for potential curative alloHSCT." @default.
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• W3214560541 date "2021-11-08" @default.
• W3214560541 modified "2023-10-17" @default.
• W3214560541 title "Clinical Experience With Venetoclax in Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia." @default.
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• W3214560541 doi "https://doi.org/10.21203/rs.3.rs-1026952/v1" @default.
• W3214560541 hasPublicationYear "2021" @default.
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