文章：

苯达莫司汀、硼替佐米和地塞米松在复发难治性多发性骨髓瘤患者中的疗效和耐受性：一项II期研究

Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

原文发布日期：2013-11-22

DOI: 10.1038/bcj.2013.58

类型: Original Article

开放获取: 是

英文摘要：

Bendamustine demonstrated synergistic efficacy with bortezomib against multiple myeloma (MM) cells in vitro and seems an effective treatment for relapsed-refractory MM (rrMM). This phase II study evaluated bendamustine plus bortezomib and dexamethasone (BVD) administered over six 28-day cycles and then every 56 days for six further cycles in patients with rrMM treated with ⩽4 prior therapies and not refractory to bortezomib. The primary study end point was the overall response rate after four cycles. In total, 75 patients were enrolled, of median age 68 years. All patients had received targeted agents, 83% had 1–2 prior therapies and 33% were refractory to the last treatment. The response rate⩾partial response (PR) was 71.5% (16% complete response, 18.5% very good PR, 37% partial remission). At 12 months of follow-up, median time-to-progression (TTP) was 16.5 months and 1-year overall survival was 78%. According to Cox regression analysis, only prior therapy with bortezomib plus lenalidomide significantly reduced TTP (9 vs 17 months; hazard ratio=4.5; P=0.005). The main severe side effects were thrombocytopenia (30.5%), neutropenia (18.5%), infections (12%), neuropathy (8%) and gastrointestinal and cardiovascular events (both 6.5%). The BVD regimen is feasible, effective and well-tolerated in difficult-to-treat patients with rrMM.

摘要翻译： 

苯达莫司汀在体外与硼替佐米对多发性骨髓瘤细胞展现出协同疗效，似乎是治疗复发难治性多发性骨髓瘤的有效方案。这项II期研究评估了苯达莫司汀联合硼替佐米与地塞米松方案，针对既往接受≤4线治疗且对硼替佐米不耐药的复发难治性多发性骨髓瘤患者：先进行6个周期（每28天为一周期）治疗，随后每56天一次再完成6个周期。主要研究终点为4个周期后的总缓解率。共入组75例中位年龄68岁的患者，所有患者均接受过靶向药物治疗，83%曾有1-2线治疗史，33%对末次治疗耐药。总缓解率（达到部分缓解及以上）达71.5%（完全缓解16%，非常好的部分缓解18.5%，部分缓解37%）。中位随访12个月时，中位无进展生存期为16.5个月，1年总生存率为78%。Cox回归分析显示，既往接受硼替佐米联合来那度胺治疗会显著缩短无进展生存期（9个月 vs 17个月；风险比=4.5；P=0.005）。主要严重不良反应包括血小板减少症（30.5%）、中性粒细胞减少症（18.5%）、感染（12%）、神经病变（8%）、胃肠及心血管事件（各6.5%）。对于难治性复发难治性多发性骨髓瘤患者，苯达莫司汀联合硼替佐米与地塞米松方案具有可行性、有效性及良好耐受性。

原文链接：

Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study