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本文引用的文献

1
First-line thalidomide-dexamethasone therapy in preparation for auto-SCT in young patients (<61 years) with symptomatic multiple myeloma.沙利度胺-地塞米松一线治疗用于准备接受自体造血干细胞移植的61岁以下有症状的多发性骨髓瘤年轻患者。
Bone Marrow Transplant. 2009 Jun;43(11):893. doi: 10.1038/bmt.2009.113.
2
Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure.低剂量沙利度胺与泼尼松龙的巩固治疗可延长接受单次自体干细胞移植手术的多发性骨髓瘤患者的生存期。
J Clin Oncol. 2009 Apr 10;27(11):1788-93. doi: 10.1200/JCO.2008.18.8573. Epub 2009 Mar 9.
3
Long-term follow-up results of IFM99-03 and IFM99-04 trials comparing nonmyeloablative allotransplantation with autologous transplantation in high-risk de novo multiple myeloma.IFM99 - 03和IFM99 - 04试验的长期随访结果:高危初发多发性骨髓瘤患者非清髓性同种异体移植与自体移植的比较
Blood. 2008 Nov 1;112(9):3914-5. doi: 10.1182/blood-2008-07-168823.
4
Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma.硼替佐米联合美法仑和泼尼松用于多发性骨髓瘤的初始治疗。
N Engl J Med. 2008 Aug 28;359(9):906-17. doi: 10.1056/NEJMoa0801479.
5
Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities.全疗法2中的沙利度胺组可改善中期细胞遗传学异常的骨髓瘤患者的完全缓解持续时间和生存率。
Blood. 2008 Oct 15;112(8):3115-21. doi: 10.1182/blood-2008-03-145235. Epub 2008 May 20.
6
Sustained complete remissions in multiple myeloma linked to bortezomib in total therapy 3: comparison with total therapy 2.在总治疗方案3中与硼替佐米相关的多发性骨髓瘤持续完全缓解:与总治疗方案2的比较
Br J Haematol. 2008 Mar;140(6):625-34. doi: 10.1111/j.1365-2141.2007.06921.x.
7
Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial.单剂量自体干细胞移植后使用沙利度胺维持治疗在多发性骨髓瘤中优于双剂量自体移植:一项多中心随机临床试验的结果
Blood. 2008 Feb 15;111(4):1805-10. doi: 10.1182/blood-2007-07-101212. Epub 2007 Sep 17.
8
Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA--Italian Multiple Myeloma Network.美法仑、泼尼松和来那度胺治疗新诊断的骨髓瘤:来自GIMEMA(意大利多发性骨髓瘤网络)的报告
J Clin Oncol. 2007 Oct 1;25(28):4459-65. doi: 10.1200/JCO.2007.12.3463. Epub 2007 Sep 4.
9
Long-term outcome results of the first tandem autotransplant trial for multiple myeloma.首例多发性骨髓瘤序贯自体移植试验的长期结果
Br J Haematol. 2006 Oct;135(2):158-64. doi: 10.1111/j.1365-2141.2006.06271.x. Epub 2006 Aug 25.
10
Maintenance therapy with thalidomide improves survival in patients with multiple myeloma.沙利度胺维持治疗可改善多发性骨髓瘤患者的生存率。
Blood. 2006 Nov 15;108(10):3289-94. doi: 10.1182/blood-2006-05-022962. Epub 2006 Jul 27.

自体移植治疗多发性骨髓瘤的长期随访:法国骨髓瘤协作组、西南肿瘤协作组和阿肯色大学医学科学中心进行的方案更新。

Long-term follow-up of autotransplantation trials for multiple myeloma: update of protocols conducted by the intergroupe francophone du myelome, southwest oncology group, and university of arkansas for medical sciences.

机构信息

Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, 4301 West Markham, #816, Little Rock, AR 72205;

出版信息

J Clin Oncol. 2010 Mar 1;28(7):1209-14. doi: 10.1200/JCO.2009.25.6081. Epub 2010 Jan 19.

DOI:10.1200/JCO.2009.25.6081
PMID:20085933
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2834471/
Abstract

PURPOSE

The purpose of this study was to update outcomes of autotransplantation trials for myeloma conducted by the Intergroupe Francophone du Myelome (IFM), the Southwest Oncology Group, and the University of Arkansas for Medical Sciences (Total Therapy [TT]).

METHODS

IFM90 (N = 194), IFM04 (N = 402), IFM9902 (N = 692), IFM9904 (N = 197), S9321 (N = 817), TT1 (N = 231), TT2 (N = 668), and TT3 (N = 303) were updated, and results were compared with original reports.

RESULTS

Superior survival with single transplantation versus standard therapy in IFM90 was confirmed (P = .004), and a trend in favor of tandem versus single transplantation was maintained in IFM94 (P = .08). S9321 data were validated, with comparable survival in single transplantation and standard treatment arms (P = .35). A survival benefit from thalidomide maintenance in IFM9902 was not confirmed (P = .39) but emerged for the thalidomide arm of TT2 (P = .04). On multivariate analysis, survival was superior in TT2, TT3, and IFM9902 (all P < .001); tandem transplantations were superior to both single transplantations and standard therapies (P < .001), as were tandem transplantations with added thalidomide versus trials without thalidomide (P < .001). Postrelapse survival (PRS) was superior when initial event-free survival (EFS) exceeded 1280 days and when tandem transplantations had been administered, whereas PRS was shorter when EFS lasted 803 days or less and when trials had included thalidomide and bortezomib.

CONCLUSION

These long-term follow-up data of transplantation trials provide a crucial framework of reference for outcome reporting of novel agent-based trials reportedly exhibiting remarkable short-term efficacy approaching high-dose therapy results.

摘要

目的

本研究旨在更新由法国骨髓瘤研究组(IFM)、美国西南肿瘤协作组(SWOG)和阿肯色大学医学科学分校(Total Therapy [TT])开展的骨髓瘤自体移植试验的结果。

方法

对 IFM90(N=194)、IFM04(N=402)、IFM9902(N=692)、IFM9904(N=197)、S9321(N=817)、TT1(N=231)、TT2(N=668)和 TT3(N=303)进行了更新,并与原始报告结果进行了比较。

结果

IFM90 中,单次移植优于标准治疗的生存优势得到了确认(P=0.004),IFM94 中仍倾向于串联移植优于单次移植(P=0.08)。S9321 的数据得到了验证,单次移植和标准治疗组的生存情况相当(P=0.35)。在 IFM9902 中,沙利度胺维持治疗并未带来生存获益(P=0.39),但 TT2 的沙利度胺组则出现了获益(P=0.04)。多变量分析显示,TT2、TT3 和 IFM9902 的生存情况均优于其他组(均 P<0.001);串联移植优于单次移植和标准治疗(P<0.001),且添加沙利度胺的串联移植优于无沙利度胺的试验(P<0.001)。当初始无事件生存(EFS)超过 1280 天时,或当进行串联移植时,缓解后生存(PRS)更好,而当 EFS 持续时间为 803 天或更短时,或当试验包括沙利度胺和硼替佐米时,PRS 更短。

结论

这些移植试验的长期随访数据为新型药物试验的结果报告提供了一个重要的参考框架,这些试验显示出显著的短期疗效,接近高剂量治疗的结果。