Real-World Evidence on Prognostic Value of MRD in Multiple Myeloma Using Flow Cytometry

IF 2.3 3区 医学 Q2 HEMATOLOGY
Ludmila Muronova, Ondrej Soucek, David Zihala, Tereza Sevcikova, Tereza Popkova, Hana Plonkova, Ondrej Venglar, Ludek Pour, Martin Stork, Lucie Rihova, Renata Bezdekova, Jiri Minarik, Vojtech Látal, Martin Novak, Alexandra Jungova, Tereza Dekojova, Jan Straub, Martin Spacek, Vladimira Rezacova, Vladimir Maisnar, Jakub Radocha, Roman Hajek, Tomas Jelinek
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Abstract

Minimal residual disease (MRD) is one of the most important prognostic factors in multiple myeloma (MM) and a valid surrogate for progression-free survival (PFS) and overall survival (OS). Recently, MRD negativity was approved as an early clinical endpoint for accelerated drug approval in MM. Nevertheless, there is limited evidence of MRD utility in real-world setting. In this retrospective multicenter study, we report outcomes of 331 newly diagnosed MM patients with MRD evaluation at Day+100 after autologous stem cell transplantation using flow cytometry with a median limit of detection of 0.001%. MRD negativity was reached in 47% of patients and was associated with significantly prolonged median PFS (49.2 months vs. 18.4 months; hazard ratios (HR) = 0.37; p < 0.001) and OS (not reached vs. 74.9 months; HR = 0.50; p = 0.007). Achieving MRD negativity was associated with PFS improvements regardless of age, International Staging System (ISS) stage, lactate dedydrogenase (LDH) level, or cytogenetic risk. Importantly, MRD positive patients benefited from lenalidomide maintenance versus no maintenance (18-months PFS: 81% vs. 46%; HR = 0.24; p = 0.002) while in MRD negative patients such benefit was not observed (p = 0.747). The outcomes of our real-world study recapitulate results from clinical trials including meta-analyses and support the idea that MRD positive patients profit more from lenalidomide maintenance than MRD negative ones.

Abstract Image

使用流式细胞术对多发性骨髓瘤 MRD 的预后价值进行实证分析。
最小残留病灶(MRD)是多发性骨髓瘤(MM)最重要的预后因素之一,也是无进展生存期(PFS)和总生存期(OS)的有效替代指标。最近,MRD 阴性被批准作为多发性骨髓瘤加速药物审批的早期临床终点。然而,MRD在现实世界中的应用证据还很有限。在这项回顾性多中心研究中,我们报告了331名新诊断的MM患者在自体干细胞移植后第+100天使用流式细胞术进行MRD评估的结果,中位检测限为0.001%。47%的患者达到了MRD阴性,这与中位PFS显著延长有关(49.2个月 vs. 18.4个月;危险比(HR)= 0.37;P<0.05)。
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来源期刊
CiteScore
5.50
自引率
0.00%
发文量
168
审稿时长
4-8 weeks
期刊介绍: European Journal of Haematology is an international journal for communication of basic and clinical research in haematology. The journal welcomes manuscripts on molecular, cellular and clinical research on diseases of the blood, vascular and lymphatic tissue, and on basic molecular and cellular research related to normal development and function of the blood, vascular and lymphatic tissue. The journal also welcomes reviews on clinical haematology and basic research, case reports, and clinical pictures.
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