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