Durie B G M, Harousseau J-L, Miguel J S, Bladé J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar S V
Aptium Oncology, Inc., Cedars-Sinai Outpatient Cancer Center, Los Angeles, CA 90048, USA.
Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
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.
需要新的统一反应标准来充分评估骨髓瘤的临床结果。欧洲血液和骨髓移植组/国际骨髓移植登记处的标准已得到扩展、澄清和更新,以提供一个新的综合评估系统。增加了严格完全缓解和非常好的部分缓解类别。纳入血清游离轻链检测以评估寡分泌性疾病患者。澄清了先前标准中的不一致之处,使反应确认和疾病进展更容易进行。重点将事件发生时间和反应持续时间作为关键终点。讨论了将总生存时间作为最终终点所需的条件。预计多发性骨髓瘤国际反应标准将在未来骨髓瘤的临床试验中广泛应用。