Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma
Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma
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DOI：
10.1182/blood-2012-02-408898
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发表时间：
2012-07-05
期刊：
影响因子：
20.3
通讯作者：
Palumbo, Antonio
中科院分区：
文献类型：
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作者：
Cavo, Michele;Pantani, Lucia;Palumbo, Antonio
在一项随机的3期研究中，对于新诊断的骨髓瘤患者，在双次自体干细胞移植前和之后的诱导治疗中，波特佐米-沙利度胺-地塞米松(VTD)和沙利度胺-地塞米松(TD)作为诱导治疗，以及巩固后，显示出更高的完全/接近完全缓解(CR/NCR)率和延长的无进展生存期(意向治疗分析；VTD，n=236；TD，n=238)。这项按方案进行的分析(VTD，n=160；TD，n=161)专门评估了VTD或TD巩固的有效性和安全性。在开始巩固前，VTD组和TD组的CR/NCR率差异无统计学意义(63.1%和54.7%)。合并后，VTD组的CR率(60.6%比46.6%)和CR/NCR率(73.1%比60.9%)显著高于TD组。VTD合并显著增加CR率和CR/NCR率，而TD无显著差异(McNemar检验)。从合并开始的中位随访期为30.4个月，VTD组的3年无进展生存期显著长于TD组(60%比48%)。VTD合并2级或3级周围神经病变(8.1%比2.4%)比合并TD更常见(3级，0.6%)。两次自体移植后，尽管给予巩固治疗，VTD的诱导效果仍优于TD。VTD巩固疗法显著改善了随机分配到研究VTD组的患者的临床结果。这项研究在www.Clinicaltrials.gov上注册为#NCT01134484。(血。2012年；120(1)：9-19)
In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484. (Blood. 2012;120(1):9-19)