Suppr超能文献

硼替佐米和来那度胺难治性多发性骨髓瘤患者接受泊马度胺联合低剂量地塞米松治疗:法国骨髓瘤协作组 2009-02 研究。

Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myélome 2009-02.

机构信息

Hôpital Huriez, CHRU, Lille, France.

出版信息

Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

Abstract

The combination of pomalidomide and dexamethasone can be safely administered to patients with multiple myeloma (MM) and has significant efficacy, although the optimal regimen remains to be determined. Patients with MM whose disease progressed after multiple lines of therapy have limited treatment options. We designed a multicenter, phase 2 randomized study assessing two different dose regimens of pomalidomide and dexamethasone in advanced MM. Treatment response was assessed centrally. Pomalidomide (4 mg) was given orally on days 1 to 21 (arm 21/28) or continuously (arm 28/28) over a 28-day cycle, plus dexamethasone given weekly. Eighty-four patients (43, arm 21/28 and 41, arm 28/28) were randomized. The median number of prior lines was 5. Overall response rate was 35% (arm 21/28) and 34% (arm 28/28), independent of the number of prior lines and level of refractoriness. Median duration of response, time to disease progression, and progression-free survival was 7.3, 5.4, and 4.6 months, respectively, which was similar across cohorts. At 23 months follow-up, median overall survival was 14.9 months, with 44% of the patients alive at 18 months. Toxicity consisted primarily of myelosuppression, which was manageable. The efficacy and safety data presented here, along with data from other phase 2 trials, suggest that pomalidomide 4 mg per day on days 1 to 21 of 28 with dexamethasone should be investigated in future trials. This trial is registered at ClinicalTrials.gov (No. NCT01053949).

摘要

泊马度胺联合地塞米松可安全用于多发性骨髓瘤(MM)患者,且疗效显著,尽管最佳方案仍有待确定。经过多线治疗后疾病进展的 MM 患者治疗选择有限。我们设计了一项多中心、2 期随机研究,评估了两种不同剂量方案的泊马度胺联合地塞米松在晚期 MM 中的应用。采用中心评估治疗反应。泊马度胺(4 mg)在第 1 至 21 天(21/28 组)或连续(28/28 组)口服,每 28 天为一个周期,同时给予地塞米松每周给药。84 例患者(43 例接受 21/28 方案,41 例接受 28/28 方案)被随机分组。既往治疗线数中位数为 5 条。总体缓解率分别为 35%(21/28 组)和 34%(28/28 组),与既往治疗线数和难治程度无关。中位缓解持续时间、疾病进展时间和无进展生存期分别为 7.3、5.4 和 4.6 个月,各队列间相似。23 个月随访时,中位总生存期为 14.9 个月,18 个月时仍有 44%的患者存活。毒性主要为骨髓抑制,但可管理。本文提供的疗效和安全性数据,以及其他 2 期试验的数据,表明在未来的试验中应进一步研究泊马度胺 4 mg 每日 1 次连用 21 天,与地塞米松联合应用,28 天为一个周期。该试验在 ClinicalTrials.gov 注册(编号 NCT01053949)。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验