Thalidomide and hematopoietic-cell transplantation for multiple myeloma
Thalidomide and hematopoietic-cell transplantation for multiple myeloma
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DOI：
10.1056/nejmoa053583
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发表时间：
2006-03-09
影响因子：
158.5
通讯作者：
Crowley, J
中科院分区：
文献类型：
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作者：
Barlogie, B;Tricot, G;Crowley, J
背景：高剂量马法兰治疗可以延长多发性骨髓瘤患者的生存期。我们评估了添加具有抗晚期和难治性骨髓瘤活性的沙利度胺是否会进一步提高生存率。 方法：1998 年 10 月至 2004 年 2 月，668 名新诊断的多发性骨髓瘤患者接受了两个周期的基于马法兰的强化化疗，每个周期均辅以自体造血干细胞移植。共有 323 名患者被随机分配从一开始就接受沙利度胺治疗，直至疾病进展或出现过度不良反应，另外 345 名患者没有接受沙利度胺治疗。主要终点是五年无事件生存率。次要终点是完全缓解和总生存率。 结果：在幸存者中位随访 42 个月后，沙利度胺组和对照组的完全缓解率分别为 62% 和 43%（P
BACKGROUND:High-dose therapy with melphalan can prolong survival among patients with multiple myeloma. We assessed whether the addition of thalidomide, which has activity against advanced and refractory myeloma, would further improve survival.METHODS:Between October 1998 and February 2004, 668 patients with newly diagnosed multiple myeloma received two cycles of intensive melphalan-based chemotherapy, each supported by autologous hematopoietic stem-cell transplantation. A total of 323 were randomly assigned to receive thalidomide from the outset until disease progression or undue adverse effects, and 345 did not receive thalidomide. The primary end point was the five-year event-free survival rate. Secondary end points were complete response and overall survival.RESULTS:After a median follow-up of 42 months among survivors, the thalidomide and control groups had rates of complete response of 62 percent and 43 percent, respectively (P