会议报告:2018年多发性骨髓瘤微小残留病检测进展

Ola Landgren, Even H. Rustad
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引用次数: 18

摘要

本报告总结了2018年9月14日在纽约市举行的第五届多发性骨髓瘤微小残留病(MRD)检测年度研讨会,该研讨会汇集了来自学术界、工业界和FDA的专家。提出了三项建议:(a)除了完全缓解(CR)外,还应在获得非常好的部分缓解(VGPR)的患者中进行MRD检测;(b) 1 000 000个骨髓细胞(10−6)中有1个肿瘤细胞的MRD阴性应与目前定义的10−5的MRD阴性一起被视为反应类别;(c)临床试验报告应指定MRD检测的敏感性以及MRD阴性的应用阈值(即10 - 5或10 - 6),如果可能的话,报告两个MRD阈值的结果数据。总的来说,正如会议上讨论的那样,已经有确凿的证据表明,基于骨髓的MRD评估是多发性骨髓瘤最有力的预后因素之一,更深层次的反应与越来越有利的结果相关。事实上,实现MRD的消极性似乎比使用什么治疗方法更重要。展望未来,有必要开展MRD导向治疗的临床试验,以确定MRD检测在日常临床决策中的作用。MRD测试的标准化和跨中心的协调将使从共同经验中学习变得更加容易。预计在不久的将来,MRD将成为加速多发性骨髓瘤药物审批的监管终点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Meeting report: Advances in minimal residual disease testing in multiple myeloma 2018

This report summarizes the 5th annual symposium on minimal residual disease (MRD) testing in multiple myeloma gathered experts from academia, industry and the FDA in New York City on 14 September 2018. Three recommendations were made: (a) MRD testing should be performed in patients who achieve a very good partial response (VGPR) in addition to complete response (CR); (b) MRD negativity at one tumor cell in 1 000 000 bone marrow cells (10−6) should be considered as a response category alongside the current definition of MRD negativity at 10−5; and (c) clinical trials reports should specify the sensitivity of MRD testing as well as the applied threshold for MRD negativity (ie, 10−5 or 10−6), and if possible report outcome data for both MRD thresholds. Overall, as discussed at the meeting, there is already solid evidence that bone marrow based MRD assessment is one of the strongest prognostic factors in multiple myeloma, and deeper responses correlate with increasingly favorable outcomes. Indeed, achieving MRD negativity appears to be more important than what treatment was used to get there. Going forward, there is a need for clinical trials focusing on MRD-directed therapy to determine the role of MRD testing in everyday clinical decision-making. Standardization of MRD testing and harmonization across centers will make it easier to learn from common experiences. Ongoing efforts are anticipated to establish MRD status as a regulatory endpoint for accelerated drug approval in multiple myeloma in the near future.

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