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
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
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DOI：
10.1200/jco.2009.25.6081
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发表时间：
2010-03-01
影响因子：
45.3
通讯作者：
Harousseau, Jean-Luc
中科院分区：
文献类型：
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作者：
Barlogie, Bart;Attal, Michel;Harousseau, Jean-Luc
目的：本研究的目的是更新骨髓瘤自体移植试验的结果，这些试验由法语骨髓瘤intergroup （IFM）、西南肿瘤小组和阿肯色大学医学科学（Total Therapy [TT]）进行。方法更新sifm90 （N = 194）、IFM04 （N = 402）、IFM9902 （N = 692）、IFM9904 （N = 197）、S9321 （N = 817）、TT1 （N = 231）、TT2 （N = 668）、TT3 （N = 303）的数据，并与原始报告进行比较。结果证实，IFM90患者单次移植比标准治疗生存率更高（P = 0.004）， IFM94患者单次移植比单次移植生存率更高（P = 0.08）。S9321的数据得到了验证，单次移植组和标准治疗组的生存率相当（P = 0.35）。IFM9902中沙利度胺维持的生存获益未得到证实（P = 0.39），但在TT2的沙利度胺组中出现（P = 0.04）。多因素分析显示，TT2、TT3和IFM9902患者的生存率更高（P < 0.001）；串联移植优于单次移植和标准治疗（P = .001），添加沙利度胺的串联移植优于不添加沙利度胺的试验（P < .001）。当初始无事件生存期（EFS）超过1280天并且进行了串联移植时，复发后生存期（PRS）更优越，而当EFS持续803天或更短，并且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重要的参考框架，据报道，这些药物的短期疗效接近大剂量治疗结果。
PurposeThe 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]).MethodsIFM90 (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.ResultsSuperior 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.ConclusionThese 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.