Consolidation Therapy With Low-Dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a Single Autologous Stem-Cell Transplantation Procedure
Consolidation Therapy With Low-Dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a Single Autologous Stem-Cell Transplantation Procedure
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DOI：
10.1200/jco.2008.18.8573
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发表时间：
2009-04-10
影响因子：
45.3
通讯作者：
Kennedy, Nola
中科院分区：
文献类型：
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作者：
Spencer, Andrew;Prince, H. Miles;Kennedy, Nola
目的沙利度胺治疗初治和复发/难治性多发性骨髓瘤（MM）有效。然而，沙利度胺在自体干细胞移植（ASCT）后的作用仍不清楚.这项研究评估是否增加沙利度胺巩固ASCT后将提高持久性的反应实现和总survival.Patients和MethodsBetween 2002年1月和2005年3月，269例新诊断的MM谁实现疾病稳定或更好的常规诱导化疗接受了单次高剂量美法仑条件ASCT。ASCT后，129例患者被随机分配接受无限期泼尼松龙维持治疗（对照组），114例患者在接受12个月沙利度胺巩固治疗（沙利度胺组）的基础上接受泼尼松龙维持治疗。主要研究终点为无进展生存期（PFS）和总生存期（OS）.结果中位随访3年后，随机化后3年PFS率分别为42%和23（P <0.001;风险比[HR]，0.5; 95%CI，0.35 - 0.71），OS率分别为86%和75%。（P <0.004; HR，0.41; 95%CI，0.22 - 0.76）。疾病进展后12个月，两组之间的生存率没有差异（79% vs77%; P = 0.237）。神经系统毒性反应更常见的沙利度胺组，但有没有手臂之间的差异血栓embolic events.ConclusionConsolidation治疗与12个月的沙利度胺联合泼尼松龙生存期后，一个单一的高剂量治疗支持ASCT新诊断的MM患者。此外，沙利度胺巩固治疗没有不利影响生存在随后的挽救设置。J Clin Oncol 27：1788 - 1793. (C)2009年美国临床肿瘤学会
PurposeThalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma ( MM). However, the role of thalidomide in the post- autologous stem cell transplantation ( ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival.Patients and MethodsBetween January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better with conventional induction chemotherapy received a single high- dose melphalan conditioned ASCT. Post- ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy ( control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation ( thalidomide group). The primary study end points were progression- free survival ( PFS) and overall survival ( OS). The secondary end point was tolerability.ResultsAfter a median follow- up of 3 years, the postrandomization 3- year PFS rates were 42% and 23% ( P < .001; hazard ratio [ HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% ( P < .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression ( 79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events.ConclusionConsolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high- dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting. J Clin Oncol 27: 1788-1793. (C) 2009 by American Society of Clinical Oncology