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依鲁替尼、泊马度胺和地塞米松是一种耐受性非常好的方案,即使在非常晚期的骨髓瘤中也能产生持久缓解:来自两个学术中心的回顾性研究。

Elotuzumab, pomalidomide, and dexamethasone is a very well tolerated regimen associated with durable remission even in very advanced myeloma: a retrospective study from two academic centers.

机构信息

Division of Hematology, Wuerzburg University Medical Center, Würzburg, Germany.

Division of Psychosomatic Medicine, Wuerzburg University Medical Center, Würzburg, Germany.

出版信息

J Cancer Res Clin Oncol. 2021 Jan;147(1):205-212. doi: 10.1007/s00432-020-03323-6. Epub 2020 Jul 18.

Abstract

BACKGROUND

The anti-SLAMF7 monoclonal antibody, elotuzumab (elo), plus lenalidomide (len) and dexamethasone (dex) is approved for relapsed/refractory MM in the U.S. and Europe. Recently, a small phase 2 study demonstrated an advantage in progression-free survival (PFS) for elo plus pomalidomide (pom)/dex compared to pom/dex alone and resulted in licensing of this novel triplet combination, but clinical experience is still limited.

PURPOSE

To analyze the efficacy and safety of elo/pom/dex in a "real world" cohort of patients with advanced MM, we queried the databases of the university hospitals of Würzburg and Vienna.

FINDINGS

We identified 22 patients with a median number of five prior lines of therapy who received elo/pom/dex prior to licensing within an early access program. Patients received a median number of 5 four-week treatment cycles. Median PFS was 6.4 months with 12-month and 18-month PFS rates of 35% and 28%, respectively. The overall response rate was 50% and 64% of responding patients who achieved a longer PFS with elo/pom/dex compared to their most recent line of therapy. Objective responses were also seen in five patients who had been pretreated with pomalidomide. Low tumor burden was associated with improved PFS (13.5 months for patients with ISS stage I/II at study entry v 6.4 months for ISS III), although this difference did not reach statistical significance. No infusion-related reactions were reported. The most frequent grade 3/4 adverse events were neutropenia and pneumonia.

CONCLUSION

Elo/pom/dex is an active and well-tolerated regimen in highly advanced MM even after pretreatment with pomalidomide.

摘要

背景

抗 SLAMF7 单克隆抗体依洛珠单抗(elo)联合来那度胺(len)和地塞米松(dex)在美国和欧洲获批用于治疗复发/难治性多发性骨髓瘤。最近,一项小型 2 期研究表明,elo 联合泊马度胺(pom)/dex 与单独使用 pom/dex 相比,无进展生存期(PFS)有优势,并因此获得了这一新三联疗法的许可,但临床经验仍有限。

目的

为了分析依洛珠单抗/泊马度胺/地塞米松(elo/pom/dex)在晚期多发性骨髓瘤的“真实世界”患者队列中的疗效和安全性,我们查询了维尔茨堡大学医院和维也纳大学医院的数据库。

发现

在早期准入计划中,我们在获得许可之前,共确定了 22 名接受过 elo/pom/dex 治疗的患者,这些患者的中位治疗线数为 5 条,中位接受了 5 个 4 周的治疗周期。中位 PFS 为 6.4 个月,12 个月和 18 个月的 PFS 率分别为 35%和 28%。总缓解率为 50%,64%的缓解患者与最近的治疗线相比,PFS 更长。在先前接受过泊马度胺治疗的 5 名患者中也观察到了客观缓解。肿瘤负荷低与 PFS 改善相关(研究入组时 ISS 分期 I/II 的患者 PFS 为 13.5 个月,ISS 分期 III 的患者为 6.4 个月),尽管这一差异没有达到统计学意义。未报告与输注相关的反应。最常见的 3/4 级不良事件是中性粒细胞减少和肺炎。

结论

即使在先前接受过泊马度胺治疗的情况下,elo/pom/dex 对晚期多发性骨髓瘤也是一种有效且耐受良好的治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f3a/11802014/ea10250a9793/432_2020_3323_Fig1_HTML.jpg

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