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[Efficacy of selinexor combined with subcutaneous decitabine in myeloid malignancies refractory to or relapsed after venetoclax therapy].塞利尼索联合皮下注射地西他滨治疗对维奈克拉治疗难治或复发的髓系恶性肿瘤的疗效
Zhonghua Xue Ye Xue Za Zhi. 2025 May 14;46(5):473-477. doi: 10.3760/cma.j.cn121090-20240920-00358.
2
Thrombopoietin mimetics for patients with myelodysplastic syndromes.用于骨髓增生异常综合征患者的血小板生成素模拟物。
Cochrane Database Syst Rev. 2017 Sep 30;9(9):CD009883. doi: 10.1002/14651858.CD009883.pub2.
3
Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study.口服地西他滨和西扎珠苷联合维奈克拉治疗老年或身体不适的急性髓系白血病患者:一项2期研究。
Lancet Haematol. 2024 Apr;11(4):e276-e286. doi: 10.1016/S2352-3026(24)00033-4. Epub 2024 Mar 4.
4
Efficacy and safety of venetoclax-based combination therapy for previously untreated acute myeloid leukemia: a meta-analysis.基于 venetoclax 的联合疗法治疗未经治疗的急性髓系白血病的疗效和安全性:一项荟萃分析。
Hematology. 2024 Dec;29(1):2343604. doi: 10.1080/16078454.2024.2343604. Epub 2024 May 4.
5
The efficacy and safety of venetoclax combined with decitabine in elderly patients with acute myeloid leukemia: a systematic review and meta-analysis.维奈托克联合地西他滨治疗老年急性髓系白血病患者的疗效和安全性:一项系统评价和荟萃分析。
Clin Exp Med. 2025 Jul 9;25(1):239. doi: 10.1007/s10238-025-01794-w.
6
[Retrospective Analysis of Venetoclax Combined with Azacitidine Compared with "3+7" or Similar Regimens for Newly Diagnosed Patients with Acute Myeloid Leukemia].维奈克拉联合阿扎胞苷与“3+7”或类似方案治疗新诊断急性髓系白血病患者的回顾性分析
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):672-681. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.008.
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[Short-Term Efficacy of Low-Dose Venetoclax Combined with CHG Priming Regimen in Patients with AML and High-Risk MDS Ineligible for Intensive Chemotherapy].[低剂量维奈克拉联合CHG预激方案对不适合强化化疗的急性髓系白血病和高危骨髓增生异常综合征患者的短期疗效]
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):660-665. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.006.
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Bexmarilimab plus azacitidine for high-risk myelodysplastic syndrome and relapsed or refractory acute myeloid leukaemia: results from the dose-escalation part of a multicentre, single-arm, phase 1/2 trial.贝克斯马里单抗联合阿扎胞苷治疗高危骨髓增生异常综合征及复发或难治性急性髓系白血病:一项多中心、单臂、1/2期试验剂量递增部分的结果
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Venetoclax and decitabine vs intensive chemotherapy as induction for young patients with newly diagnosed AML.维奈托克与地西他滨对比强化化疗用于新诊断急性髓系白血病年轻患者的诱导治疗
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Midostaurin added to 10-day decitabine, for patients unfit for intensive chemotherapy with AML and higher risk MDS, irrespective of FLT3 mutational status, does not improve outcome.对于不适合接受强化化疗的急性髓系白血病(AML)和高危骨髓增生异常综合征(MDS)患者,无论其FMS样酪氨酸激酶3(FLT3)突变状态如何,在10天的地西他滨治疗基础上加用米哚妥林并不能改善预后。
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本文引用的文献

1
[Efficacy and safety analysis of venetoclax combined with hypomethylating agents for the treatment of higher-risk myelodysplastic syndromes in the real world].维奈克拉联合去甲基化药物治疗高危骨髓增生异常综合征的真实世界疗效与安全性分析
Zhonghua Xue Ye Xue Za Zhi. 2024 Feb 14;45(2):156-162. doi: 10.3760/cma.j.cn121090-20230926-00136.
2
Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia.VIALE-A 研究的长期随访:不适合化疗的初治急性髓系白血病患者中应用维奈克拉联合阿扎胞苷。
Am J Hematol. 2024 Apr;99(4):615-624. doi: 10.1002/ajh.27246. Epub 2024 Feb 11.
3
[Efficacy analysis of selinexor combined with hypomethylating agent in the treatment of refractory/relapsed acute myeloid leukemia exposed to venetoclax].塞利尼索联合去甲基化药物治疗经维奈克拉治疗的难治性/复发性急性髓系白血病的疗效分析
Zhonghua Xue Ye Xue Za Zhi. 2023 Nov 14;44(11):936-939. doi: 10.3760/cma.j.issn.0253-2727.2023.11.009.
4
[Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)].《成人急性髓系白血病(非急性早幼粒细胞白血病)诊断与治疗中国指南(2023年版)》
Zhonghua Xue Ye Xue Za Zhi. 2023 Sep 14;44(9):705-712. doi: 10.3760/cma.j.issn.0253-2727.2023.09.001.
5
The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms.世界卫生组织血液淋巴肿瘤分类第五版:髓系和组织细胞/树突状肿瘤。
Leukemia. 2022 Jul;36(7):1703-1719. doi: 10.1038/s41375-022-01613-1. Epub 2022 Jun 22.
6
Venetoclax plus 3 + 7 daunorubicin and cytarabine chemotherapy as first-line treatment for adults with acute myeloid leukaemia: a multicentre, single-arm, phase 2 trial.维奈克拉联合 3+7 方案的柔红霉素和阿糖胞苷化疗作为成人急性髓系白血病一线治疗:一项多中心、单臂、2 期临床试验。
Lancet Haematol. 2022 Jun;9(6):e415-e424. doi: 10.1016/S2352-3026(22)00106-5. Epub 2022 May 2.
7
Safety and activity of selinexor in patients with myelodysplastic syndromes or oligoblastic acute myeloid leukaemia refractory to hypomethylating agents: a single-centre, single-arm, phase 2 trial.塞利尼索治疗对低甲基化药物难治的骨髓增生异常综合征或原始细胞过少性急性髓系白血病患者的安全性及活性:一项单中心、单臂、2期试验
Lancet Haematol. 2020 Aug;7(8):e566-e574. doi: 10.1016/S2352-3026(20)30209-X.
8
Outcomes of relapsed or refractory acute myeloid leukemia after frontline hypomethylating agent and venetoclax regimens.一线使用去甲基化药物和维奈克拉方案治疗后复发或难治性急性髓系白血病的疗效
Haematologica. 2021 Mar 1;106(3):894-898. doi: 10.3324/haematol.2020.252569.
9
Efficacy and predictive factors of venetoclax combined with azacitidine as salvage therapy in advanced acute myeloid leukemia patients: A multicenter retrospective study.维奈托克联合阿扎胞苷作为晚期急性髓系白血病患者挽救治疗的疗效及预测因素:一项多中心回顾性研究
Leuk Res. 2020 Apr;91:106317. doi: 10.1016/j.leukres.2020.106317. Epub 2020 Feb 14.
10
Venetoclax response is enhanced by selective inhibitor of nuclear export compounds in hematologic malignancies.在血液系统恶性肿瘤中,核输出化合物的选择性抑制剂可增强维奈托克的疗效。
Blood Adv. 2020 Feb 11;4(3):586-598. doi: 10.1182/bloodadvances.2019000359.

塞利尼索联合皮下注射地西他滨治疗对维奈克拉治疗难治或复发的髓系恶性肿瘤的疗效

[Efficacy of selinexor combined with subcutaneous decitabine in myeloid malignancies refractory to or relapsed after venetoclax therapy].

作者信息

Mi R H, Wang L, Hu N, Li C, Chen L, Ma Y X, Wei X D

机构信息

The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital, Zhengzhou 450008, China.

Huaihe Hospital of Henan University, Kaifeng 475000, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2025 May 14;46(5):473-477. doi: 10.3760/cma.j.cn121090-20240920-00358.

DOI:10.3760/cma.j.cn121090-20240920-00358
PMID:40623908
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12268302/
Abstract

Venetoclax (Ven) is now widely used for both acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS), yet there is no consensus on salvage regimens after Ven failure. This study retrospectively evaluated the efficacy and safety of selinexor combined with subcutaneous decitabine (DAC) in 10 patients with AML or MDS with excess blasts (MDS-EB1/2) who had experienced prior Ven treatment failure. A literature review was also performed. Among the 7 patients with AML, 1 achieved complete remission (CR), 2 achieved CR with incomplete hematologic recovery (CRi), 1 achieved partial remission (PR), 2 had no remission, and 1 experienced disease progression (PD). Among the 3 patients with MDS, 2 achieved marrow CR and 1 had stable disease (SD). The median duration of response among the 6 responding patients was 2 months (range, 0.5-6 months). All 10 patients experienced varying degrees of myelosuppression. Five patients had mild gastrointestinal reactions, all of which were manageable. The overall tolerability was good, and no treatment-related deaths occurred. These findings suggest that selinexor combined with subcutaneous decitabine offers a novel and well-tolerated therapeutic option for patients with myeloid malignancies who have previously failed venetoclax-based therapy.

摘要

维奈克拉(Ven)目前广泛用于急性髓系白血病(AML)和高危骨髓增生异常综合征(MDS),但对于Ven治疗失败后的挽救方案尚无共识。本研究回顾性评估了塞利尼索联合皮下注射地西他滨(DAC)对10例曾接受过Ven治疗失败的AML或伴有过多原始细胞的MDS(MDS-EB1/2)患者的疗效和安全性。同时进行了文献综述。在7例AML患者中,1例达到完全缓解(CR),2例达到血液学不完全缓解的CR(CRi),1例达到部分缓解(PR),2例未缓解,1例疾病进展(PD)。在3例MDS患者中,2例达到骨髓CR,1例疾病稳定(SD)。6例有反应的患者的中位反应持续时间为2个月(范围0.5 - 6个月)。所有10例患者均经历了不同程度的骨髓抑制。5例患者有轻度胃肠道反应,均可控。总体耐受性良好,未发生与治疗相关的死亡。这些发现表明,塞利尼索联合皮下注射地西他滨为先前基于维奈克拉的治疗失败的髓系恶性肿瘤患者提供了一种新的且耐受性良好的治疗选择。