文章：

卡非佐米-来那度胺-地塞米松对比来那度胺-地塞米松用于既往治疗过的复发性多发性骨髓瘤

Carfilzomib–lenalidomide–dexamethasone vs lenalidomide–dexamethasone in relapsed multiple myeloma by previous treatment

原文发布日期：2017-04-21

DOI: 10.1038/bcj.2017.31

类型: Original Article

开放获取: 是

英文摘要：

Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide–dexamethasone (Rd) for relapsed or refractory multiple myeloma. The approval of carfilzomib–lenalidomide–dexamethasone (KRd) was based on results from the randomized, phase 3 study ASPIRE (NCT01080391), which showed KRd significantly improved progression-free survival (PFS) vs Rd (median 26.3 vs 17.6 months; hazard ratio (HR)=0.690; P=0.0001). This subgroup analysis of ASPIRE evaluated KRd vs Rd by number of previous lines of therapy and previous exposure to bortezomib, thalidomide or lenalidomide. Treatment with KRd led to a 12-month improvement in median PFS vs Rd after first relapse (HR 0.713) and a 9-month improvement after ⩾2 previous lines of therapy (HR 0.720). Treatment with KRd led to an approximate 8-month improvement vs Rd in median PFS in bortezomib-exposed patients (HR 0.699), a 15-month improvement in thalidomide-exposed patients (HR 0.587) and a 5-month improvement in lenalidomide-exposed patients (HR 0.796). Objective response and complete response or better rates were higher with KRd vs Rd, irrespective of previous treatment. KRd had a favorable benefit–risk profile and should be considered an appropriate treatment option for patients with 1 or ⩾2 previous lines of therapy and those previously exposed to bortezomib, thalidomide or lenalidomide.

摘要翻译： 

卡非佐米是一种蛋白酶体制剂，获批作为单药治疗以及与地塞米松或来那度胺-地塞米松（Rd）联合治疗复发或难治性多发性骨髓瘤。卡非佐米-来那度胺-地塞米松（KRd）方案的获批基于随机3期研究ASPIRE（NCT01080391）的结果，该研究显示与Rd相比，KRd显著改善了无进展生存期（PFS）（中位PFS 26.3个月 vs 17.6个月；风险比[HR]=0.690；P=0.0001）。本次对ASPIRE研究的亚组分析根据既往治疗线数以及既往硼替佐米、沙利度胺或来那度胺暴露情况评估了KRd与Rd的疗效。在首次复发后，KRd治疗相比Rd使中位PFS延长12个月（HR 0.713），在既往接受过≥2线治疗的患者中延长9个月（HR 0.720）。在硼替佐米暴露过的患者中，KRd治疗相比Rd使中位PFS延长约8个月（HR 0.699），在沙利度胺暴露过的患者中延长15个月（HR 0.587），在来那度胺暴露过的患者中延长5个月（HR 0.796）。无论既往接受何种治疗，KRd组的客观缓解率及完全缓解或更佳缓解率均高于Rd组。KRd具有有利的获益-风险特征，应考虑作为既往接受过1线或≥2线治疗以及既往暴露于硼替佐米、沙利度胺或来那度胺的患者的合适治疗选择。

原文链接：

Carfilzomib–lenalidomide–dexamethasone vs lenalidomide–dexamethasone in relapsed multiple myeloma by previous treatment