文章：

来那度胺联合地塞米松长期治疗复发/难治性多发性骨髓瘤患者的疗效与安全性

Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma

原文发布日期：2014-11-07

DOI: 10.1038/bcj.2014.77

类型: Original Article

开放获取: 是

英文摘要：

Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ⩾3 years). Patients with long-term benefit of therapy (n=45) had a median duration of treatment of 48.1 months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55%; P=0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age<65 years (P=0.03), β2-microglobulin <2.5 mg/l (P=0.002) and fewer prior therapies (P=0.002). The exposure-adjusted incidence rate (EAIR) of grade 3–4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects.

摘要翻译： 

两项评估来那度胺与地塞米松联合治疗复发/难治性多发性骨髓瘤（RRMM）的三期随机关键试验数据被合并分析，以明确获得长期治疗获益（无进展生存期≥3年）的患者亚组特征。获得长期治疗获益的患者（n=45）中位治疗时间为48.1个月，缓解率达到100%。其中体液免疫指标（非受累免疫球蛋白A）改善更常见（79% vs 55%；P=0.002）。多变量分析显示，长期治疗获益的显著预测因素包括年龄<65岁（P=0.03）、β2-微球蛋白<2.5 mg/l（P=0.002）及既往治疗线数较少（P=0.002）。长期获益患者的3-4级中性粒细胞减少症暴露校正发生率较低（每100患者年13.9例 vs 38.2例），而侵袭性第二原发恶性肿瘤的暴露校正发生率与其他患者相同（每100患者年1.7例）。这些结果表明，RRMM患者通过来那度胺与地塞米松治疗可获得长期获益，且副作用可控。

原文链接：

Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma