Real-world effectiveness of first-line azacitidine or decitabine with or without venetoclax in acute myeloid leukemia patients unfit for intensive therapy

IF 2.3 3区医学 Q2 HEMATOLOGY

European Journal of Haematology Pub Date : 2024-07-18 DOI:10.1111/ejh.14278

Fabian Acker, Jörg Chromik, Emily Tiedjen, Sebastian Wolf, Jonas B. Vischedyk, Philipp Makowka, Julius C. Enßle, Khouloud Kouidri, Martin Sebastian, Björn Steffen, Thomas Oellerich, Hubert Serve, Andreas Neubauer, Jonas A. Schäfer, Jörg T. Bittenbring

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引用次数: 0

Abstract

Background

First-line treatment in patients with acute myeloid leukemia (AML) unfit for intensive therapy is the combination of a hypomethylating agent (HMA) with venetoclax (VEN). However, retrospective data confirming the benefits of this regimen outside of clinical trials have shown conflicting results.

Methods

We performed a multicenter retrospective analysis of outcomes with first-line HMA–VEN versus HMA in AML patients unfit for intensive chemotherapy.

Results

A total of 213 patients were included from three German hospitals (125 HMA–VEN, 88 HMA). Median overall survival in the HMA–VEN cohort was 7.9 months (95% confidence interval [CI], 5.1–14.7) versus 4.9 months (3.1–7.1) with HMA. After 1 year, 42% (95% CI, 33–54) and 19% (12–30) of patients were alive, respectively (hazard ratio [HR] for death, 0.64; 95% CI, 0.46–0.88). After adjusting for clinical and molecular baseline characteristics, treatment with HMA–VEN remained significantly associated with both prolonged survival (HR, 0.48; 95% CI, 0.29–0.77) and time to next treatment (HR, 0.63; 95% CI, 0.47–0.85). Patients who achieved recovery of peripheral blood counts had a favorable prognosis (HR for death, 0.52; 95% CI, 0.33–0.84).

Discussion

These data align with findings from the pivotal VIALE-A trial and support the use of HMA–VEN in patients unfit for intensive therapy.

Abstract Image

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一线阿扎胞苷或地西他滨联合或不联合 venetoclax 对不适合强化治疗的急性髓性白血病患者的实际疗效。

背景：不适合接受强化治疗的急性髓性白血病（AML）患者的一线治疗方案是将低甲基化药物（HMA）与venetoclax（VEN）联合使用。然而，在临床试验之外，证实该方案益处的回顾性数据显示出了相互矛盾的结果：我们对不适合接受强化化疗的急性髓细胞性白血病患者一线HMA-VEN与HMA的疗效进行了多中心回顾性分析：结果：三家德国医院共纳入213例患者（125例HMA-VEN，88例HMA）。HMA-VEN 组群的中位总生存期为 7.9 个月（95% 置信区间 [CI]，5.1-14.7），而 HMA 为 4.9 个月（3.1-7.1）。1年后，分别有42%（95% CI，33-54）和19%（12-30）的患者存活（死亡危险比[HR]为0.64；95% CI，0.46-0.88）。对临床和分子基线特征进行调整后，使用 HMA-VEN 治疗仍与延长生存期（HR，0.48；95% CI，0.29-0.77）和下次治疗时间（HR，0.63；95% CI，0.47-0.85）显著相关。外周血计数恢复的患者预后良好（死亡HR，0.52；95% CI，0.33-0.84）：这些数据与关键的 VIALE-A 试验结果一致，支持在不适合接受强化治疗的患者中使用 HMA-VEN。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Haematology 医学-血液学

CiteScore

5.50

自引率

0.00%

发文量

168

审稿时长

4-8 weeks

期刊介绍： European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.