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在复发/难治性多发性骨髓瘤中,伊沙佐米来那度胺和地塞米松联合的真实世界疗效和安全性结果:来自匈牙利伊沙佐米命名患者项目的数据收集。

Real World Efficacy and Safety Results of Ixazomib Lenalidomide and Dexamethasone Combination in Relapsed/Refractory Multiple Myeloma: Data Collected from the Hungarian Ixazomib Named Patient Program.

机构信息

3rd Department of Internal Medicine, Semmelweis University, H-1125, Kútvölgyi út 4, Budapest, Hungary.

1st Department of Internal Medicine, Semmelweis University, Budapest, Hungary.

出版信息

Pathol Oncol Res. 2019 Oct;25(4):1615-1620. doi: 10.1007/s12253-019-00607-2. Epub 2019 Feb 2.

DOI:10.1007/s12253-019-00607-2
PMID:30712192
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6815275/
Abstract

Ixazomib-Revlimid-Dexamethasone is an all-oral treatment protocol for multiple myeloma with a manageable tolerability profile which was available through a named patient program for Hungarian patients from December 2015 to April 2017. We analyzed the clinical characteristics and survival of 77 patients treated at 7 centers within this program. The majority of patients responded, we found complete response in 9, very good partial response in 8, partial response in 32, minor response or stable disease in 13 and progressive disease in 11 patients. Progression free survival was 11.4 months. There was a trend of longer progression free survival in those with 1 vs. >1 prior treatment, with equally good effectivity in standard risk and high risk cytogenetic groups. The adverse events were usually mild, none leading to permanent drug interruptions. There were 5 fatalities: 3 infections and 2 pulmonary embolisms. Our real word data support the use of Ixazomib-Revlimid-Dexamethasone as a highly effective and well tolerated oral treatment protocol for relapsed myeloma.

摘要

来那度胺-硼替佐米-地塞米松是一种用于多发性骨髓瘤的全口服治疗方案,具有可管理的耐受性,在 2015 年 12 月至 2017 年 4 月期间,通过匈牙利患者的患者指定计划可获得。我们分析了在该计划的 7 个中心接受治疗的 77 名患者的临床特征和生存情况。大多数患者有反应,我们发现 9 例完全缓解,8 例非常好的部分缓解,32 例部分缓解,13 例轻微缓解或稳定疾病,11 例疾病进展。无进展生存期为 11.4 个月。与之前接受治疗 >1 次的患者相比,1 次接受治疗的患者无进展生存期更长,标准风险和高风险细胞遗传学组的疗效同样良好。不良反应通常较轻,没有导致药物永久性中断。有 5 例死亡:3 例感染和 2 例肺栓塞。我们的真实数据支持来那度胺-硼替佐米-地塞米松作为一种有效且耐受性良好的复发性骨髓瘤口服治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafe/6815275/4990f16ee32c/12253_2019_607_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafe/6815275/036221b44adc/12253_2019_607_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafe/6815275/4990f16ee32c/12253_2019_607_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafe/6815275/036221b44adc/12253_2019_607_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bafe/6815275/4990f16ee32c/12253_2019_607_Fig2_HTML.jpg

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Healthcare resource utilization with ixazomib or placebo plus lenalidomide-dexamethasone in the randomized, double-blind, phase 3 TOURMALINE-MM1 study in relapsed/refractory multiple myeloma.在复发/难治性多发性骨髓瘤的随机、双盲、3期TOURMALINE-MM1研究中,使用伊沙佐米或安慰剂联合来那度胺-地塞米松的医疗资源利用情况。
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