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新型基于药物的方案作为新诊断多发性骨髓瘤患者自体干细胞移植前的诱导治疗:一项随机对照试验的荟萃分析。

Novel agents-based regimens as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: a meta-analysis of randomized controlled trials.

机构信息

E.N.T. department, Weifang People's Hospital of Weifang Medical University, Weifang, China.

出版信息

Hematol Oncol. 2012 Jun;30(2):57-61. doi: 10.1002/hon.1007. Epub 2011 Aug 2.

DOI:10.1002/hon.1007
PMID:21809367
Abstract

To investigate the effect of novel agents like bortezomib, lenalidomide and thalidomide as part of induction treatment prior to autologous stem-cell transplantation (ASCT) for previously untreated patients with multiple myeloma, we performed a meta-analysis of randomized controlled trials (RCTs). Medline, Embase, the Cochrane controlled trials register and the Science Citation Index were searched for RCTs of novel agents as part of induction therapy before ASCT. Three RCTs of bortezomib, two RCTs of thalidomide and no RCT of lenalidomide were identified, covering a total of 2,316 subjects. Due to different mechanisms of action, we performed a subgroup analysis by type of agent (thalidomide or bortezomib). The weighted risk ratios of a complete response (CR) were 4.25 [95% CI: 2.44-7.41] (p < 0.001) for bortezomib and 1.66 [95% CI: 1.15-2.38] (p = 0.007) for thalidomide, respectively. The summary hazard ratios for progression-free survival (PFS) were 0.73 [95% CI: 0.59-0.89] (p = 0.002) for bortezomib and 0.68 [95% CI: 0.59-0.79] (p < 0.001) for thalidomide, respectively. The corresponding ratios for overall survival (OS) were 0.87 [95% CI: 0.64-1.18] (p = 0.37) and 0.88 [95% CI: 0.73-1.05] (p = 0.14), respectively. Additionally, there was a statistically significant heterogeneity between subgroups (thalidomide and bortezomib) for CR (p = 0.005) but nonsignificant for PFS (p = 0.64) and OS (p = 0.97). In conclusion, our analysis showed novel agents as induction treatment prior to ASCT improved CR and PFS but not OS.

摘要

为了研究硼替佐米、来那度胺和沙利度胺等新型药物作为新诊断多发性骨髓瘤患者自体干细胞移植(ASCT)前诱导治疗的一部分的效果,我们对随机对照试验(RCT)进行了荟萃分析。检索了 Medline、Embase、Cochrane 对照试验注册中心和科学引文索引,以寻找新型药物作为 ASCT 前诱导治疗的 RCT。确定了三项硼替佐米 RCT、两项来那度胺 RCT 和一项 lenalidomide RCT,共涵盖了 2316 名受试者。由于作用机制不同,我们按药物类型(沙利度胺或硼替佐米)进行了亚组分析。完全缓解(CR)的加权风险比分别为硼替佐米 4.25 [95% CI:2.44-7.41](p<0.001)和沙利度胺 1.66 [95% CI:1.15-2.38](p=0.007)。无进展生存期(PFS)的汇总风险比分别为硼替佐米 0.73 [95% CI:0.59-0.89](p=0.002)和沙利度胺 0.68 [95% CI:0.59-0.79](p<0.001)。总生存期(OS)的相应比值分别为硼替佐米 0.87 [95% CI:0.64-1.18](p=0.37)和沙利度胺 0.88 [95% CI:0.73-1.05](p=0.14)。此外,CR 亚组(沙利度胺和硼替佐米)之间存在统计学显著异质性(p=0.005),但 PFS(p=0.64)和 OS(p=0.97)无显著异质性。总之,我们的分析表明,新型药物作为 ASCT 前的诱导治疗可提高 CR 和 PFS,但不能提高 OS。

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