A preliminary analysis of the efficacy and safety of homoharringtonine, venetoclax, and azacitidine for newly diagnosed acute myeloid leukemia
10.3760/cma.j.cn121090-20241111-00443
- VernacularTitle:高三尖杉酯碱联合维奈克拉、阿扎胞苷治疗初诊急性髓系白血病的疗效及安全性初步分析
- Author:
Hao AI
1
;
Qian WANG
1
;
Hongfei WU
1
;
Qingsong YIN
1
Author Information
1. 郑州大学附属肿瘤医院、河南省肿瘤医院血液科，郑州 450008
- Publication Type:Journal Article
- Keywords:
Homoharringtonine;
Venetoclax;
Azacytidine;
Leukemia, myeloid, acute
- From:
Chinese Journal of Hematology
2025;46(10):937-942
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the efficacy and safety of two induction regimens, homoharringtonine plus venetoclax and azacitidine (VHA) versus venetoclax and azacitidine (VA) , for newly diagnosed acute myeloid leukemia (AML) patients who are elderly or ineligible for intensive chemotherapy.Methods:We retrospectively analyzed the clinical data of 59 newly diagnosed AML patients treated with the VHA or VA regimen at Zhengzhou University Affiliated Cancer Hospital from September 2018 to July 2021. The cohort included 25 males and 34 females, with a median age of 63 years. The overall response rate (ORR) , composite complete remission (CRc) rate [CR+CR with incomplete hematologic recovery (CRi) ], minimal residual disease (MRD) negativity rate, overall survival (OS) , relapse-free survival (RFS) , and adverse events were compared between the two groups. Survival was estimated by the Kaplan-Meier method, and prognostic factors were evaluated using univariable and multivariable Cox regression.Results:At the end of the treatment, the ORR was 88.4% (23/26) in the VHA group [21 CR, 2 partial remissions (PR) ] and 90.9% (30/33) in the VA group (25 CR, 5 PR) , with no significant difference between the groups ( P=0.458) . The MRD negativity rates after one cycle of induction were 73.1% (19/26) in the VHA group and 60.6% (20/33) in the VA group, respectively ( P=0.315) . In the high-risk subgroup, the composite remission rates after one cycle were 78.6% (11/14) with VHA and 50.0% (5/10) with VA ( P=0.143) ; MRD negativity rates were 64.3% (9/14) and 20.0% (2/10) , respectively ( P=0.032) . The main adverse events were myelosuppression, gastrointestinal reactions, and infections during neutropenia. Rates of grade 3-4 neutropenia and decreased hemoglobin were similar between groups, whereas grade 3-4 thrombocytopenia was more frequent with VHA than with VA (76.9% vs 45.5%, P=0.015) . With a median follow-up of 13 months (range, 1-59) , 1 year RFS was 69.9% (95% CI: 53.1%-92.2%) with VHA and 55.6% (95% CI: 40.1%-77.1%) with VA ( P=0.305) . The 1 year OS rates were 91.7% (95% CI: 77.3%-100.0%) and 58.2% (95% CI: 41.7%-81.4%) , respectively ( P=0.024) . Among high risk patients, 1 year RFS and OS were higher with VHA than with VA (RFS: 66.2% vs 37.5%, P=0.046; OS: 85.7% vs 48.0%, P=0.011) . Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) significantly improved RFS and OS ( P=0.027 and 0.047, respectively) . On multivariable analysis, ELN risk classification and MRD negativity after the first cycle were independent prognostic factors for RFS. Treatment regimen (VHA vs VA) , MRD negativity after the first cycle, and receipt of transplantation were independent prognostic factors for OS. Conclusion:VHA provides clinical benefit in newly diagnosed AML patients who are unfit for intensive chemotherapy and in older adults, with particularly favorable outcomes in high risk patients; sequential allo-HSCT confers additional benefit, and associated adverse events are manageable.
