Universidade Federal do Rio de Janeiro, Brazil.
Am J Hematol. 2012 Oct;87(10):948-52. doi: 10.1002/ajh.23274. Epub 2012 Jun 23.
Despite the good response of stem cell transplant (SCT) in the treatment of multiple myeloma (MM), most patients relapse or do not achieve complete remission, suggesting that additional treatment is needed. We assessed the impact of thalidomide in maintenance after SCT in untreated patients with MM. A hundred and eight patients (<70 years old) were randomized to receive maintenance with dexamethasone (arm A; n = 52) or dexamethasone with thalidomide (arm B; n = 56; 200 mg daily) for 12 months or until disease progression. After a median follow-up of 27 months, an intention to treat analysis showed a 2-year progression-free survival (PFS) of 30% in arm A (95% CI 22-38) and 64% in arm B (95% CI 57-71; P = 0.002), with median PFS of 19 months and 36 months, respectively. In patients who did not achieve at least a very good partial response, the PFS at 2 years was significantly higher when in use of thalidomide (19 vs. 59%; P = 0.002). Overall survival at 2 years was not significantly improved (70 vs. 85% in arm A and arm B, respectively; P = 0.27). The addition of thalidomide to dexamethasone as maintenance improved the PFS mainly in patients who did not respond to treatment after SCT.
尽管干细胞移植（SCT）在多发性骨髓瘤（MM）的治疗中反应良好，但大多数患者仍会复发或未达到完全缓解，这表明需要额外的治疗。我们评估了沙利度胺在未经治疗的 MM 患者 SCT 后维持治疗中的作用。108 名（<70 岁）患者被随机分为接受地塞米松维持治疗（A 组，n = 52）或地塞米松联合沙利度胺（B 组，n = 56；每天 200mg）维持治疗 12 个月或直至疾病进展。中位随访 27 个月后，意向治疗分析显示 A 组 2 年无进展生存率（PFS）为 30%（95%CI 22-38），B 组为 64%（95%CI 57-71；P = 0.002），中位 PFS 分别为 19 个月和 36 个月。在未达到至少非常好的部分缓解的患者中，使用沙利度胺的 PFS 明显更高（2 年时分别为 19%和 59%；P = 0.002）。2 年总生存率无显著改善（A 组和 B 组分别为 70%和 85%；P = 0.27）。沙利度胺联合地塞米松作为维持治疗可改善 PFS，主要在 SCT 后未对治疗有反应的患者中。
