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骨髓增生异常综合征合并血小板减少症患者基线基因突变情况及艾曲泊帕和阿扎胞苷治疗结果的下一代测序：来自SUPPORT临床试验的数据

Next-generation sequencing of baseline genetic mutations and outcomes of eltrombopag and azacitidine therapy in patients with myelodysplastic syndromes and thrombocytopenia: Data from the SUPPORT clinical trial.

作者信息

Ramos Pedro Marques, Choi Jeea, Campbell Catarina D, Wang Ying A, Pallaud Celine, Dickinson Michael, Verma Amit, Mittelman Moshe, Platzbecker Uwe, Cherif Honar, Fenaux Pierre

机构信息

Novartis Pharma AG Basel Switzerland.

Novartis Pharmaceuticals Corporation East Hanover New Jersey USA.

出版信息

EJHaem. 2023 May 22;4(3):876-881. doi: 10.1002/jha2.694. eCollection 2023 Aug.

DOI:10.1002/jha2.694
PMID:37601870
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10435669/
Abstract

Eltrombopag has been previously shown to be effective in reversing azacitidine-mediated thrombocytopenia. This was further investigated in the SUPPORT trial, a phase III study assessing the efficacy/safety of eltrombopag plus azacitidine in patients with intermediate- to high-risk myelodysplastic syndromes and thrombocytopenia. The results did not support a clinical benefit for the addition of eltrombopag to azacitidine. We investigated if the somatic mutational profiles in the patient cohort were associated with treatment outcomes. Based on the available data, we observed no imbalance in the mutational profiles between treatment arms or a clear association between identified somatic mutations and clinical outcomes.

摘要

此前已证明艾曲泊帕在逆转阿扎胞苷介导的血小板减少方面有效。在SUPPORT试验中对此进行了进一步研究，这是一项III期研究，评估艾曲泊帕加阿扎胞苷在中高危骨髓增生异常综合征和血小板减少患者中的疗效/安全性。结果不支持在阿扎胞苷基础上加用艾曲泊帕具有临床益处。我们研究了患者队列中的体细胞突变谱是否与治疗结果相关。根据现有数据，我们观察到各治疗组之间的突变谱没有失衡，也未发现已识别的体细胞突变与临床结果之间存在明确关联。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a83/10435669/17e0338ad014/JHA2-4-876-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a83/10435669/5a31cf597763/JHA2-4-876-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a83/10435669/17e0338ad014/JHA2-4-876-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a83/10435669/5a31cf597763/JHA2-4-876-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a83/10435669/17e0338ad014/JHA2-4-876-g002.jpg

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Next-generation sequencing of baseline genetic mutations and outcomes of eltrombopag and azacitidine therapy in patients with myelodysplastic syndromes and thrombocytopenia: Data from the SUPPORT clinical trial.骨髓增生异常综合征合并血小板减少症患者基线基因突变情况及艾曲泊帕和阿扎胞苷治疗结果的下一代测序：来自SUPPORT临床试验的数据
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本文引用的文献

1
Azacitidine with or without eltrombopag for first-line treatment of intermediate- or high-risk MDS with thrombocytopenia.阿扎胞苷联合或不联合艾曲泊帕治疗伴有血小板减少的中高危骨髓增生异常综合征的一线治疗。
Blood. 2018 Dec 20;132(25):2629-2638. doi: 10.1182/blood-2018-06-855221. Epub 2018 Oct 10.
2
Eltrombopag for advanced myelodysplastic syndromes or acute myeloid leukaemia and severe thrombocytopenia (ASPIRE): a randomised, placebo-controlled, phase 2 trial.艾曲泊帕用于晚期骨髓增生异常综合征或急性髓系白血病及严重血小板减少症（ASPIRE）：一项随机、安慰剂对照的2期试验。
Lancet Haematol. 2018 Jan;5(1):e34-e43. doi: 10.1016/S2352-3026(17)30228-4. Epub 2017 Dec 11.
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Eltrombopag versus placebo for low-risk myelodysplastic syndromes with thrombocytopenia (EQoL-MDS): phase 1 results of a single-blind, randomised, controlled, phase 2 superiority trial.
艾曲泊帕与安慰剂治疗血小板减少的低危骨髓增生异常综合征（EQoL-MDS）：一项单盲、随机、对照、2期优效性试验的1期结果
Lancet Haematol. 2017 Mar;4(3):e127-e136. doi: 10.1016/S2352-3026(17)30012-1. Epub 2017 Feb 3.
4
Safety and tolerability of eltrombopag versus placebo for treatment of thrombocytopenia in patients with advanced myelodysplastic syndromes or acute myeloid leukaemia: a multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial.艾曲泊帕与安慰剂治疗晚期骨髓增生异常综合征或急性髓系白血病患者血小板减少症的安全性和耐受性：一项多中心、随机、安慰剂对照、双盲1/2期试验。
Lancet Haematol. 2015 Oct;2(10):e417-26. doi: 10.1016/S2352-3026(15)00149-0. Epub 2015 Oct 1.
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Do somatic mutations in de novo MDS predict for response to treatment?
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A pilot phase I dose finding safety study of the thrombopoietin-receptor agonist, eltrombopag, in patients with myelodysplastic syndrome treated with azacitidine.一项关于血小板生成素受体激动剂艾曲泊帕在接受阿扎胞苷治疗的骨髓增生异常综合征患者中的I期剂量探索性安全性试验。
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