Measurable residual disease (MRD) is an important biomarker in acute myeloid leukemia (AML) that is used for prognostic, predictive, monitoring, and efficacy-response assessments. The European LeukemiaNet (ELN) MRD Working Party evaluated standardization and harmonization of MRD in an ongoing manner and has updated the 2018 ELN MRD recommendations based on significant developments in the field. New and revised recommendations were established during in-person and online meetings, and a 2-stage Delphi poll was conducted to optimize consensus. All recommendations are graded by levels of evidence and agreement. Major changes include technical specifications for next-generation sequencing-based MRD testing and integrative assessments of MRD irrespective of technology. Other topics include use of MRD as a prognostic and surrogate end point for drug testing; selection of the technique, material, and appropriate time points for MRD assessment; and clinical implications of MRD assessment. In addition to technical recommendations for flow- and molecular-MRD analysis, we provide MRD thresholds and define MRD response, and detail how MRD results should be reported and combined if several techniques are used. MRD assessment in AML is complex and clinically relevant, and standardized approaches to application, interpretation, technical conduct, and reporting are of critical importance.

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2021 年急性髓系白血病 MRD 更新：欧洲 LeukemiaNet MRD 工作组的共识文件。


可测量残留病灶 (MRD) 是急性髓系白血病 (AML) 的重要生物标志物，用于预后、预测、监测和疗效反应评估。欧洲白血病网 (ELN) MRD 工作组持续评估 MRD 的标准化和协调性，并根据该领域的重大发展更新了 2018 年 ELN MRD 建议。在面对面和在线会议期间制定了新的和修订的建议，并进行了两阶段德尔菲投票以优化共识。所有建议均按证据和同意程度进行分级。主要变化包括基于下一代测序的 MRD 检测的技术规范以及无论技术如何的 MRD 综合评估。其他主题包括使用 MRD 作为药物测试的预后和替代终点；选择 MRD 评估的技术、材料和适当的时间点；以及 MRD 评估的临床意义。除了流式和分子 MRD 分析的技术建议外，我们还提供 MRD 阈值并定义 MRD 响应，并详细说明在使用多种技术时应如何报告和组合 MRD 结果。 AML 的 MRD 评估非常复杂且与临床相关，标准化的应用、解释、技术实施和报告方法至关重要。