Myeloma minimal residual disease testing in the United States: Evidence of improved standardization.
Myeloma minimal residual disease testing in the United States: Evidence of improved standardization.
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美国的骨髓瘤微小残留病检测：标准化改进的证据。
DOI：
10.1002/ajh.24540
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发表时间：
2016
影响因子：
12.8
通讯作者：
Landgren,Ola
中科院分区：
文献类型：
--
作者：
Salem,Dalia;Stetler-Stevenson,Maryalice;Yuan,Constance;Landgren,Ola
对于治疗多发性骨髓瘤患者的血液学家/肿瘤学家来说，一个日益重要的问题是如何在临床反应之外评估治疗的反应。因此，微小残留病(MRD)检测在评估骨髓瘤患者的治疗反应中变得越来越重要。通过流式细胞术(FC)检测MRD阴性一直与改善无进展和总存活率有关。[1]这促使食品和药物管理局(FDA)声明，如果得到适当的验证和标准化，FCMRD可以作为评估新疗法的临床试验的替代终点生物标记物。[2]FC-MRD方法学和敏感性的变异性仍然是一个挑战。在2013年的一项调查中，26家美国医疗机构中有11家证实正在进行骨髓瘤FC-MRD，方法学上存在巨大差异，灵敏度(检测限；LOD)有显著的100倍差异。[3]随后，开展了一项国际共识过程，为骨髓瘤FC-MRD检测提供经过验证的标准化方法。[4]我们进行了重复调查，以评估骨髓瘤FC-MRD检测的现状。
An increasingly important question for treating hematologists/oncologists managing patients diagnosed with multiple myeloma is how to assess response to therapy beyond clinical response. Therefore, minimal residual disease (MRD) testing became increasingly important in assessing treatment response in patients with myeloma. MRD negativity by flow cytometry (FC) is consistently associated with improved progression-free and overall survival.[1] This has prompted the Food and Drug Administration (FDA) to state that FCMRD, if appropriately validated and standardized, could be used as a surrogate end point biomarker in clinical trials evaluating novel therapies.[2] Variability in FC-MRD methodology and sensitivity, however, remains a challenge. In a survey from 2013, 11/26 US medical institutions confirmed performing myeloma FC-MRD, with enormous variability in methodology, and a striking 100-fold difference in the sensitivity (limit of detection; LOD).[3] Subsequently, an international consensus process was undertaken to provide validated standardized methods for myeloma FC-MRD testing.[4] We undertook a repeat survey to assess the current state of myeloma FC-MRD testing.