International uniform response criteria for multiple myeloma

International uniform response criteria for multiple myeloma
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DOI:
10.1038/sj.leu.2404284
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发表时间:
2006-09-01
期刊:
影响因子:
11.4
通讯作者:
Rajkumar, S. V.
Rajkumar, S. V.
中科院分区:
医学1区
文献类型:
--
作者:
Durie, B. G. M.;Harousseau, J-L;Rajkumar, S. V.

文献摘要

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需要新的统一缓解标准来充分评估骨髓瘤的临床结局。欧洲血液和骨髓移植小组/国际骨髓移植登记标准已经扩大、澄清和更新,以提供一个新的综合评价系统。增加了严格完全缓解和非常好的部分缓解类别。纳入血清游离轻链测定,以评价少分泌疾病患者。阐明了既往标准的增加,使得更容易确认缓解和疾病进展。重点放在事件发生时间和反应持续时间上,作为关键终点。使用总生存期作为最终终点的必要条件进行了讨论。预计多发性骨髓瘤的国际缓解标准将在未来的骨髓瘤临床试验中广泛使用。
New uniform response criteria are required to adequately assess clinical outcomes in myeloma. The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry criteria have been expanded, clarified and updated to provide a new comprehensive evaluation system. Categories for stringent complete response and very good partial response are added. The serum free light-chain assay is included to allow evaluation of patients with oligo-secretory disease. Inconsistencies in prior criteria are clarified making confirmation of response and disease progression easier to perform. Emphasis is placed upon time to event and duration of response as critical end points. The requirements necessary to use overall survival duration as the ultimate end point are discussed. It is anticipated that the International Response Criteria for multiple myeloma will be widely used in future clinical trials of myeloma.