Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma
Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma
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DOI：
10.1182/blood-2011-05-355081
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发表时间：
2011-11-24
期刊：
影响因子：
20.3
通讯作者：
Harousseau, Jean-Luc
中科院分区：
文献类型：
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作者：
Moreau, Philippe;Avet-Loiseau, Herve;Harousseau, Jean-Luc
Intergroupe Francophone du Myelome 进行了一项随机试验，比较多发性骨髓瘤患者在高剂量治疗 (HDT) 和自体干细胞移植 (ASCT) 前诱导使用的硼替佐米-地塞米松 (VD) 与减少剂量的硼替佐米和沙利度胺加地塞米松 (vtD) 的组合。总体而言，共有 199 名患者被集中随机分配接受 VD 或 vtD。 4 个周期后，两组的完全缓解 (CR) 率相同（vtD 组为 13%，VD 组为 12%，P = .74）。然而，vtD 组的 CR 加上非常好的部分缓解 (VGPR) 率显着更高（49% vs 36%，P = .05）。 ASCT 后，vtD 组的 CR 加 VGPR 率显着更高（74% vs 58%，P = .02）。硼替佐米和沙利度胺剂量的减少转化为周围神经病变 (PN) 发生率的降低：据报道，VD 组中 34% 的 PN 级≥2 级，而 vtD 组中这一比例为 14% (P = .001)。 vtD，包括减少硼替佐米和沙利度胺的剂量，与 VD 相比，可产生更高的 VGPR 率，可被视为 HDT/ASCT 前新的有效三联组合。这项研究在 www.clinicaltrials.gov 上注册为#NCT00910897，在 EudraCT 上注册为#2007-005204-40。 （血。2011；118(22):5752-5758）
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. This study was registered with www.clinicaltrials.gov as #NCT00910897 and EudraCT as #2007-005204-40. (Blood. 2011;118(22):5752-5758)