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文章:

流式细胞术检测可测量残留病灶:385例急性髓系白血病连续病例的检测验证与特征分析

Measurable Residual Disease Analysis by Flow Cytometry: Assay Validation and Characterization of 385 Consecutive Cases of Acute Myeloid Leukemia

原文发布日期:29 March 2025

DOI: 10.3390/cancers17071155

类型: Article

开放获取: 是

 

英文摘要:

Background/Objectives: Acute myeloid leukemia (AML) is a biologically heterogeneous malignancy with a variable prognosis. Despite many patients achieving complete remission, relapse remains common, underscoring the need for effective prognostic markers. Measurable residual disease (MRD) has emerged as a critical prognostic indicator, associated with higher relapse risk and shorter survival. This study reports on our initial experience of MRD detection by flow cytometry in 385 bone marrow samples from 126 AML patients.Methods: The flow cytometry MRD assay, validated according to stringent consensus recommendations, consists of a 3-tube, 10-color panel incorporating a broad spectrum of lineage differentiation markers. Analytical specificity, sensitivity, precision, and reproducibility were evaluated, demonstrating the assay’s robustness.Results: The results reveal distinct immunophenotypic aberrancies in all AML cases, with consistent identification of aberrant immunophenotypes in follow-up specimens. AML MRD was detected in 32 out of 126 patients (25%) and in 77 out of 385 analyses (20%), with a median aberrant blast percentage of 1.87% (range, 0.01–12). A change in immunophenotype was documented in 21% of the MRD-positive cases. MRD positivity detected in the first sample studied was associated with reduced overall survival (HR: 5.153;p< 0.0001).Conclusions: Our findings support the integration of flow cytometric MRD analysis into routine clinical practice to enhance risk stratification and treatment planning for AML patients, as currently recommended by professional guidelines.

 

摘要翻译: 

背景/目的:急性髓系白血病(AML)是一种生物学异质性恶性肿瘤,其预后存在显著差异。尽管许多患者能够达到完全缓解,但复发仍十分常见,这凸显了对有效预后标志物的迫切需求。可测量残留病(MRD)已成为关键的预后指标,与更高的复发风险和更短的生存期相关。本研究报告了我们对126例AML患者的385份骨髓样本进行流式细胞术MRD检测的初步经验。 方法:本研究采用的流式细胞术MRD检测方案严格遵循共识建议进行验证,包含一个3管、10色的抗体组合,涵盖了广泛的谱系分化标志物。通过对分析特异性、灵敏度、精密度和可重复性的评估,证明了该检测方法的稳健性。 结果:结果显示所有AML病例均存在独特的免疫表型异常,并且在随访样本中能够一致性地识别出异常免疫表型。在126例患者中有32例(25%),以及在385次分析中有77次(20%)检测到AML MRD,异常原始细胞的中位百分比为1.87%(范围:0.01–12)。在21%的MRD阳性病例中观察到了免疫表型的改变。在所研究的首个样本中检测到的MRD阳性与总生存期缩短相关(风险比:5.153;p < 0.0001)。 结论:我们的研究结果支持将流式细胞术MRD分析整合到常规临床实践中,以加强AML患者的风险分层和治疗规划,正如当前专业指南所推荐的那样。

 

原文链接:

Measurable Residual Disease Analysis by Flow Cytometry: Assay Validation and Characterization of 385 Consecutive Cases of Acute Myeloid Leukemia

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