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首页> 外文期刊>The New England journal of medicine >Antitumor activity of thalidomide in refractory multiple myeloma (see comments)
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Antitumor activity of thalidomide in refractory multiple myeloma (see comments)

机译：沙利度胺在难治性多发性骨髓瘤中的抗肿瘤活性（见评论）

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BACKGROUND: Patients with myeloma who relapse after high-dose chemotherapy have few therapeutic options. Since increased bone marrow vascularity imparts a poor prognosis in myeloma, we evaluated the efficacy of thalidomide, which has antiangiogenic properties, in patients with refractory disease. METHODS: Eighty-four previously treated patients with refractory myeloma (76 with a relapse after high-dose chemotherapy) received oral thalidomide as a single agent for a median of 80 days (range, 2 to 465). The starting dose was 200 mg daily, and the dose was increased by 200 mg every two weeks until it reached 800 mg per day. Response was assessed on the basis of a reduction of the myeloma protein in serum or Bence Jones protein in urine that lasted for at least six weeks. RESULTS: The serum or urine levels of paraprotein were reduced by at least 90 percent in eight patients (two had a complete remission), at least 75 percent in six patients, at least 50 percent in seven patients, and at least 25 percent in six patients, for a total rate of response of 32 percent. Reductions in the paraprotein levels were apparent within two months in 78 percent of the patients with a response and were associated with decreased numbers of plasma cells in bone marrow and increased hemoglobin levels. The microvascular density of bone marrow did not change significantly in patients with a response. At least one third of the patients had mild or moderate constipation, weakness or fatigue, or somnolence. More severe adverse effects were infrequent (occurring in less than 10 percent of patients), and hematologic effects were rare. As of the most recent follow-up, 36 patients had died (30 with no response and 6 with a response). After 12 months of follow-up, Kaplan-Meier estimates of the mean (+/-SE) rates of event-free survival and overall survival for all patients were 22+/-5 percent and 58+/-5 percent, respectively. CONCLUSIONS: Thalidomide is active against advanced myeloma. It can induce marked and durable responses in some patients with multiple myeloma, including those who relapse after high-dose chemotherapy.
机译：背景：大剂量化疗后复发的骨髓瘤患者几乎没有治疗选择。由于增加的骨髓血管使骨髓瘤的预后较差，因此我们评估了具有抗血管生成特性的沙利度胺在难治性疾病患者中的疗效。方法：八十四例先前接受治疗的难治性骨髓瘤患者（76例在大剂量化疗后复发）接受沙利度胺单药口服治疗，中位数为80天（范围2至465）。起始剂量为每天200 mg，并且剂量每两周增加200 mg，直到达到每天800 mg。根据持续至少六周的血清中骨髓瘤蛋白或尿液中Bence Jones蛋白的减少来评估反应。结果：八名患者的血清或尿中副蛋白水平降低了至少90％（两名已完全缓解），六名患者至少降低了75％，七名患者至少降低了50％，六名中至少降低了25％患者，总缓解率为32％。在78％的有反应的患者中，副蛋白水平在两个月内明显降低，并且与骨髓中浆细胞数量减少和血红蛋白水平升高有关。有反应的患者骨髓的微血管密度没有明显改变。至少三分之一的患者患有轻度或中度便秘，虚弱或疲劳或嗜睡。很少发生更严重的不良反应（发生在不到10％的患者中），血液学影响很少见。截至最近的随访，已有36例患者死亡（30例无反应，6例有反应）。随访12个月后，Kaplan-Meier对所有患者的无事件生存率和总体生存率的平均（+/- SE）估计分别为22 +/- 5％和58 +/- 5％。结论：沙利度胺对晚期骨髓瘤具有活性。在一些多发性骨髓瘤患者中，包括在大剂量化疗后复发的患者中，它可以诱导明显而持久的反应。

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