文章：

伊沙佐米治疗对硼替佐米未耐药的复发性多发性骨髓瘤患者的II期试验

Phase 2 trial of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib

原文发布日期：2015-08-14

DOI: 10.1038/bcj.2015.60

类型: Original Article

开放获取: 是

英文摘要：

This phase 2 trial was designed to evaluate ixazomib, an orally bioavailable proteasome inhibitor, in patients with myeloma who have limited prior exposure to bortezomib. Thirty-three patients with relapsed multiple myeloma were enrolled. Ixazomib was given at 5.5 mg weekly for 3 of 4 weeks. Dexamethasone was added for lack of a minor response (MR) by end of cycle 2 or lack of a partial response (PR) by end of cycle 4 or for disease progression at any time. Median age was 69 years; patients had a median of two prior therapies (range 1–7). A grade 3 or 4 adverse event considered at least possibly related to drug was seen in 19 (59%) and 6 (19%) patients, respectively. The most common adverse events were thrombocytopenia, fatigue, nausea and diarrhea. Dexamethasone was initiated in 22 (67%) patients, 17 for not reaching the desired response and 5 for progression. Response (⩾PR) to single agent was seen in five patients within four cycles of therapy including three patients with PR, one patient with complete response (CR) and one patient with stringent CR. Six additional patients with either an MR (2) or SD (4) achieved a PR after addition of dexamethasone, translating to an overall response rate of 34%.

摘要翻译： 

该项II期试验旨在评估ixazomib（一种口服生物可利用的蛋白酶体抑制剂）在既往硼替佐米暴露有限的多发性骨髓瘤患者中的疗效。研究入组了33例复发多发性骨髓瘤患者。Ixazomib给药方案为5.5mg每周一次，每4周给药3周。若患者在2周期末未达到微小缓解（MR），或4周期末未达到部分缓解（PR），或任意时间出现疾病进展，则联合使用地塞米松。患者中位年龄69岁，既往中位治疗线数为2线（范围1-7）。19例（59%）和6例（19%）患者分别出现3级或4级不良事件，评估认为至少可能与药物相关。最常见不良事件为血小板减少、疲劳、恶心和腹泻。22例（67%）患者启用地塞米松治疗，其中17例因未达到预期疗效，5例因疾病进展。单药治疗4个周期内，5例患者获得缓解（≥PR），包括3例PR、1例完全缓解（CR）和1例严格完全缓解。另有6例患者（2例MR，4例疾病稳定）加用地塞米松后达到PR，总体缓解率为34%。

原文链接：

Phase 2 trial of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib