Division of Hematology, Mayo Clinic, Rochester, MN, USA.
Department of Clinical Therapeutics, University of Athens, School of Medicine, Athens, Greece.
Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.
This International Myeloma Working Group consensus updates the disease definition of multiple myeloma to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions). These changes are based on the identification of biomarkers associated with near inevitable development of CRAB features in patients who would otherwise be regarded as having smouldering multiple myeloma. A delay in application of the label of multiple myeloma and postponement of therapy could be detrimental to these patients. In addition to this change, we clarify and update the underlying laboratory and radiographic variables that fulfil the criteria for the presence of myeloma-defining CRAB features, and the histological and monoclonal protein requirements for the disease diagnosis. Finally, we provide specific metrics that new biomarkers should meet for inclusion in the disease definition. The International Myeloma Working Group recommends the implementation of these criteria in routine practice and in future clinical trials, and recommends that future studies analyse any differences in outcome that might occur as a result of the new disease definition.
本国际骨髓瘤工作组共识更新了多发性骨髓瘤的疾病定义,除了现有的归因于 CRAB 特征(高钙血症、肾衰竭、贫血和骨病变)的要求外,还纳入了经过验证的生物标志物。这些变化基于识别与 CRAB 特征几乎不可避免发展相关的生物标志物,而这些患者在其他方面被认为患有冒烟型多发性骨髓瘤。延迟应用多发性骨髓瘤的标签和推迟治疗可能对这些患者不利。除了这一变化外,我们还澄清和更新了满足骨髓瘤定义的 CRAB 特征存在的潜在实验室和影像学变量,以及疾病诊断的组织学和单克隆蛋白要求。最后,我们提供了新的生物标志物应满足的具体指标,以纳入疾病定义。国际骨髓瘤工作组建议在常规实践和未来临床试验中实施这些标准,并建议未来的研究分析由于新的疾病定义可能导致的任何结果差异。
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