Efficacy and Safety Profile of Long-Term Exposure to Lenalidomide in Patients With Recurrent Multiple Myeloma
Efficacy and Safety Profile of Long-Term Exposure to Lenalidomide in Patients With Recurrent Multiple Myeloma
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DOI：
10.1002/cncr.28274
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发表时间：
2013-10-15
期刊：
影响因子：
6.2
通讯作者：
Leleu, Xavier
中科院分区：
文献类型：
--
作者：
Fouquet, Guillemette;Tardy, Stephanie;Leleu, Xavier
背景来那度胺联合地塞米松（Len/Dex）适用于既往接受过1种治疗直至出现疾病进展证据的复发性/难治性多发性骨髓瘤（RRMM）患者。本研究的目的是确定长期暴露于Len/Dex的疗效和安全性。方法共有50例RRMM患者接受了2年的长期Len治疗，这些患者来自2个Intergroupe Francophone du Myelome（IFM）中心（里尔和南希）被包括在本研究中。患者的中位年龄为58岁，其中30%的患者年龄>65岁，49%的患者国际分期系统分期为2期和3期，12%的患者有严重的肾功能不全，8%的患者在荧光原位杂交上显示出不良结果。约56%的患者接受Len/Dex治疗3年。Len/Dex治疗的中位持续时间为3年（范围：2年-7年）。总体队列的部分缓解或更好和非常好的部分缓解或更好的缓解率分别为96%和74%，这与暴露于Len 3年的患者相似。中位随访时间为4年，19例（38%）患者停止了Len/Dex治疗。在暴露于Len 2年的患者中，37个月时的疾病进展率分别为78%和91%，
BACKGROUNDLenalidomide in combination with dexamethasone (Len/Dex) is indicated for patients with recurrent/refractory multiple myeloma (RRMM) who were treated with 1 prior therapy until evidence of disease progression. The objective of the current study was to determine the efficacy and safety profile of long-term exposure to Len/Dex.METHODSA total of 50 patients with RRMM who were treated with long-term Len for 2 years from 2 Intergroupe Francophone du Myelome (IFM) centers (Lille and Nancy) were included in the current study.RESULTSThe median age of the patients was 58 years, with 30% of the patients aged >65 years, 49% having an International Staging System stage of 2 and 3, 12% having severe renal insufficiency, and 8% demonstrating an adverse result on fluorescence in situ hybridization. Approximately 56% of the patients received treatment with Len/Dex for 3 years. The median duration of treatment with Len/Dex was 3 years (range, 2 years-7 years). The response rates for partial response or better and very good partial response or better for the overall cohort were 96% and 74%, respectively, which is similar to patients exposed to Len for 3 years. With a median follow-up of 4 years, 19 (38%) patients had stopped treatment with Len/Dex. The time to disease progression rate at 37 months was 78% and 91%, respectively, in patients exposed to Len for 2 years to