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The Efficacy and Safety of Homoharringtonine Added to Venetoclax and Azacitidine in the Frontline Treatment of Newly Diagnosed Acute Myeloid Leukemia, a Multi-Center Exploratory Cohort Study

Guo-Pan Yu, Zurong Yao, Z. Yin, Yu Zhang, Wei-Hua Zhao, Guang-Yang Weng, Ziwen Guo, Zhi-Qiang Sun et al.

Blood, 2024

101 participants

Abstract

Purpose Our previous study showed that homoharringtonine added to venetoclax and azacitidine (HVA) improved the response compared to VA in the treatment of relapsed/refractory acute myeloid leukemia (AML) with well toleration. In this study we aimed to assess the efficacy and safety of HVA in the frontline treatment of newly diagnosed (ND) AML. Methods Patients with ND AML who were frontline treated with HVA (combined with FLT3 inhibitors in FLT3-mutated patients) for at least one cycle and had response assessment were included. The endpoint of the study was to evaluate the rate of overall response, composite complete remission (CRc), measurable residual disease (MRD), event-free survival (EFS), overall survival (OS), relapse and adverse events (AEs), and compare the efficacy and safety with that in the fit patients with “7+3” treatment and unfit patients with VA, respectively. Results 101 patients, including 73 fit and 28 unfit, with male to female 59/42, median age of 50(14-74) years, from the South China Hematology Alliance database were analyzed. After two cycles of induction, 84(83.2%) patients acquired response, 81(80.2%) CRc, 56(55.4%) MRD-negatve, including 61(83.6%), 59(80.8%) and 41(56.2%) in the fit patients, and 23(82.1%), 22(78.6%) and 15(53.6%) in the unfit patients, respectively. Patients with low risk (LR) versus (vs) intermediate risk (IR) vs high risk (HR) according to ELN 2022 or de novo vs secondary/therapy-related AML had comparable rate of CRc and…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 101 participants or records.

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