Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, 4301 West Markham, #816, Little Rock, AR 72205;
J Clin Oncol. 2010 Mar 1;28(7):1209-14. doi: 10.1200/JCO.2009.25.6081. Epub 2010 Jan 19.
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]).
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.
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.
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.
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。
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。
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。
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。