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首页> 外文期刊>Cancer investigation >Randomized Phase II trial of thalidomide alone versus thalidomide plus interferon alpha in patients with refractory multiple myeloma.
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Randomized Phase II trial of thalidomide alone versus thalidomide plus interferon alpha in patients with refractory multiple myeloma.

机译：难治性多发性骨髓瘤患者单独使用沙利度胺与沙利度胺加干扰素α的II期随机试验。

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The potential synergistic anti-myeloma effect for thalidomide combining with interferon alpha was not yet clear clinically. From March 2001 to January 2004, a total of 28 heavily pretreated multiple myleoma (MM) patients were enrolled in this open-labeled, randomized Phase II study. Patients with refractory MM were randomized to receive either thalidomide alone (200 mg/day up to the maximum dose 800 mg/day, arm B) or the combination of thalidomide and interferon alpha (3 MIU/m(2) subcutaneous injection 3 times weekly, arm A). The objective of this study was to compare the safety and efficacy of thalidomide alone to combined regimen. The patients' characteristics were similar between the 2 arms. However, the average treatment duration was significantly longer in the arm B than the arm A (236 days versus 101 days, p = 0.029). Serum levels of paraprotein decline >/= 25 percent were obtained in 6 of 12 patients (50.0 percent) treated with arm B and 3 of the 16 patients (18.8 percent) treated with arm A. The estimated time to event was 7.9 months (95 percent confidence interval [95%CI], 0.5-15.4) for arm B and 1.5 months (95%CI, 0.0-3.4) for arm A (log-rank test, p = 0.0193). The major adverse events in both arms consisted of neutropenia, anemia, thrombocytopenia, constipation, somnolence, and skin rash. Our study showed that thalidomide alone was effective and tolerated in patients with relapsed or refractory MM. The thalidomide combined with interferon alpha resulted in a lower frequency of paraprotein response, shorter treatment-duration and 25 percent of patients' refusing rate. It may be concluded that the combined regimen is not well tolerated in our patients and needed to be further evaluated in the future.
机译：沙利度胺与干扰素α联合使用的潜在协同抗骨髓瘤作用在临床上尚不清楚。从2001年3月到2004年1月，共有28位经过严格预处理的多发性骨髓瘤（MM）患者参加了这项开放标签的随机II期研究。难治性MM患者被随机分配接受沙利度胺（200 mg /天，最大剂量800 mg /天，B组）或沙利度胺和干扰素α的组合（3 MIU / m（2）每周皮下注射3次） ，手臂A）。这项研究的目的是比较单独使用沙利度胺与联合用药的安全性和有效性。两个手臂之间的患者特征相似。但是，手臂B的平均治疗时间明显长于手臂A（236天vs 101天，p = 0.029）。接受B组治疗的12名患者中有6名（50.0％）和接受A组治疗的16名患者中有3名（18.8％）的血清副蛋白水平下降≥25％ B组的可信度百分比区间[95％CI]为0.5-15.4），A组为1.5个月（95％CI为0.0-3.4）（对数秩检验，p = 0.0193）。两只手臂的主要不良事件包括中性粒细胞减少，贫血，血小板减少，便秘，嗜睡和皮疹。我们的研究表明，单独使用沙利度胺对复发或难治性MM患者有效且可耐受。沙利度胺与干扰素α的结合可降低副蛋白反应的频率，缩短治疗时间，并降低25％的患者拒绝率。可以得出结论，我们的患者对联合疗法的耐受性不佳，将来需要进一步评估。

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