Combining azole antifungals with venetoclax plus azacitidine in patients with newly diagnosed acute myeloid leukemia.

IF 2 4区 医学 Q3 HEMATOLOGY Hematology Pub Date : 2024-12-01 Epub Date: 2024-11-25 DOI:10.1080/16078454.2024.2433172
Xushu Zhong, Jia Wang, Yang Dai, Xiaoou Huang, Jiazhuo Liu, Bing Xiang, Hongbing Ma
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Abstract

The combination of venetoclax (VEN) with hypomethylating agents (HMAs) improves survival in patients with acute myeloid leukemia (AML) and may cause neutropenia requiring combined antifungal therapy or prophylaxis. The inhibition of cytochrome P450 activity by azole antifungal agents leads to elevated blood concentrations of VEN. This study aimed to evaluate the efficacy and safety of venetoclax plus azacitidine (AZA) with azoles in newly diagnosed AML patients. The primary endpoints included complete remission (CR), complete remission with incomplete blood cell recovery (CRi), composite CR (CRc, CR + CRi), blood cell recovery time and incidence of infections. The CRc was 50.0% in the azole group and 56% in the nonazole group (p > 0.05). In the azole group, the median recovery times for patients with ANC >500 cells/mm3 and ANC >1,000 cells/mm3 were 19 and 25 days, respectively. For the nonazole group, the corresponding times were 16 and 19 days (p < 0.05). In the azole group, the median durations for patients with a PLT >50,000/mm3 and >100,000/mm3 were 18 and 20 days, respectively. For the nonazole group, the corresponding times were 16 and 19 days (p > 0.05). The incidences of fungal and bacterial infections were not significantly different (30.8% vs 26.1% and 50.0% vs 56.0%) (p > 0.05). The cost-effectiveness ratio of the azole group is lower. There was no significant difference between VEN + AZA with or without azole in terms of efficacy, infection, or partial hematological toxicity. However, the combination of azoles may prolong the neutrophil recovery time. Azole combination could reduce the amount of venetoclax and improve health economics.

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在新诊断的急性髓性白血病患者中联合使用唑类抗真菌药物和 Venetoclax 加阿扎胞苷。
venetoclax(VEN)与低甲基化药物(HMAs)联用可提高急性髓性白血病(AML)患者的生存率,但可能会导致中性粒细胞减少症,需要联合抗真菌治疗或预防。唑类抗真菌药物对细胞色素 P450 活性的抑制会导致 VEN 的血药浓度升高。本研究旨在评估venetoclax联合阿扎胞苷(AZA)和唑类药物治疗新诊断的急性髓细胞性白血病患者的疗效和安全性。主要终点包括完全缓解(CR)、完全缓解但血细胞未完全恢复(CRi)、复合CR(CRc、CR + CRi)、血细胞恢复时间和感染发生率。唑类组的 CRc 为 50.0%,非唑类组的 CRc 为 56%(P > 0.05)。在唑组中,ANC >500 cells/mm3 和 ANC >1,000 cells/mm3 患者的中位恢复时间分别为 19 天和 25 天。非唑组的相应时间分别为 16 天和 19 天(P 50,000/mm3 和 >100,000/mm3 分别为 18 天和 20 天)。无唑组的相应时间分别为 16 天和 19 天(P > 0.05)。真菌和细菌感染的发生率没有明显差异(30.8% vs 26.1%和 50.0% vs 56.0%)(P > 0.05)。唑类药物组的成本效益比更低。在疗效、感染或部分血液学毒性方面,VEN + AZA联合或不联合唑类药物无明显差异。不过,联合使用唑类药物可能会延长中性粒细胞的恢复时间。联合使用唑类药物可减少 Venetoclax 的用量,提高医疗经济效益。
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来源期刊
Hematology
Hematology 医学-血液学
CiteScore
2.60
自引率
5.30%
发文量
140
审稿时长
3 months
期刊介绍: Hematology is an international journal publishing original and review articles in the field of general hematology, including oncology, pathology, biology, clinical research and epidemiology. Of the fixed sections, annotations are accepted on any general or scientific field: technical annotations covering current laboratory practice in general hematology, blood transfusion and clinical trials, and current clinical practice reviews the consensus driven areas of care and management.
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