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硼替佐米联合地塞米松与低剂量硼替佐米、沙利度胺联合地塞米松作为新诊断多发性骨髓瘤患者自体干细胞移植前的诱导治疗。

Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma.

机构信息

University Hospital, Nantes, France.

出版信息

Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.

DOI:10.1182/blood-2011-05-355081
PMID:21849487
Abstract

The Intergroupe Francophone du Myelome conducted a randomized trial to compare bortezomib-dexamethasone (VD) as induction before high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) to a combination consisting of reduced doses of bortezomib and thalidomide plus dexamethasone (vtD) in patients with multiple myeloma. Overall, a total of 199 patients were centrally randomly assigned to receive VD or vtD. After 4 cycles, the complete response (CR) rate was the same in both groups (13% in the vtD arm, 12% in the VD arm, P = .74). However, the CR plus very good partial response (VGPR) rate was significantly higher in the vtD arm (49% vs 36%, P = .05). After ASCT, the CR plus VGPR rate was significantly higher in the vtD arm (74% vs 58%, P = .02). The reduced doses of bortezomib and thalidomide translated into a reduced incidence of peripheral neuropathy (PN): grade ≥ 2 PN were reported in 34% in the VD arm versus 14% in the vtD arm (P = .001). vtD, including reduced doses of bortezomib and thalidomide, yields higher VGPR rates compared with VD and can be considered a new effective triplet combination before HDT/ASCT.

摘要

法国骨髓瘤协作组进行了一项随机试验,比较硼替佐米-地塞米松(VD)作为高强度治疗(HDT)和自体干细胞移植(ASCT)前诱导方案与包含低剂量硼替佐米、沙利度胺和地塞米松的联合方案(vtD)在多发性骨髓瘤患者中的疗效。共有 199 名患者接受中心随机分组,分别接受 VD 或 vtD 方案治疗。4 个周期后,两组完全缓解(CR)率相同(vtD 组 13%,VD 组 12%,P =.74)。但 vtD 组的 CR 加非常好的部分缓解(VGPR)率显著更高(49% vs 36%,P =.05)。ASCT 后,vtD 组的 CR 加 VGPR 率显著更高(74% vs 58%,P =.02)。低剂量硼替佐米和沙利度胺导致周围神经病变(PN)发生率降低:VD 组有 34%报告出现≥2 级 PN,而 vtD 组为 14%(P =.001)。与 VD 相比,包含低剂量硼替佐米和沙利度胺的 vtD 方案可获得更高的 VGPR 率,可被视为 HDT/ASCT 前的一种新的有效三联方案。

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