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一项关于苯达莫司汀、卡铂和地塞米松用于难治性或复发性外周T细胞淋巴瘤的II期试验(BENCART试验)。

A phase II trial of bendamustine, carboplatin, and dexamethasone for refractory or relapsed peripheral T-cell lymphoma (BENCART trial).

作者信息

Park Byeong-Bae, Kim Won Seog, Suh Cheolwon, Hong Jung Yong, Yang Deok-Hwan, Lee Won Sik, Do Young Rok, Koh Young Il, Won Jong-Ho, Kim Min Kyoung, Jo Jae-Cheol, Hyun Shin Young, Kim Jeong-A, Oh Young Ha, Lee Seung-Sook

机构信息

Department of Internal Medicine, Division of Hematology/Oncology, Hanyang University College of Medicine, Seoul, Korea.

Department of Medicine, Division of Hematology/Oncology, Samsung Medical Center, Sungkyunkwan, University School of Medicine, Seoul, Korea.

出版信息

Leuk Lymphoma. 2019 Dec;60(13):3251-3257. doi: 10.1080/10428194.2019.1622100. Epub 2019 Jun 6.

Abstract

This trial was designed to investigate the efficacy and toxicity of bendamustine, carboplatin, and dexamethasone (BCD) for relapsed or refractory peripheral T-cell lymphomas (PTCLs), which would be expected to exhibit more promising clinical outcomes compared with bendamustine therapy alone. After treatments with BCD, eight patients exhibited a complete response (CR; 29%) and seven exhibited a partial response (PR; 25%). The overall response rate (ORR) was 54%. Five patients proceeded to ASCT and three patients finally achieved CR. The median progression-free survival (PFS) was 4.4 months (2.8-6.0, 95% CI). For a total of 85 cycles of BCD, grade 3 or 4 neutropenia, thrombocytopenia, and anemia occurred in 17.6, 38.8, and 16.5% of cycles, respectively. Only one patient experienced febrile neutropenia. BCD was a considerable salvage regimen for relapsed or refractory PTCLs with acceptable toxicity; AITL or ASCT eligible patients were more effective to BCD.NCT02424045.

摘要

本试验旨在研究苯达莫司汀、卡铂和地塞米松(BCD)用于复发或难治性外周T细胞淋巴瘤(PTCL)的疗效和毒性,预计与单独使用苯达莫司汀治疗相比,其临床结果更具前景。接受BCD治疗后,8例患者出现完全缓解(CR;29%),7例出现部分缓解(PR;25%)。总缓解率(ORR)为54%。5例患者进行了自体造血干细胞移植(ASCT),3例患者最终实现CR。无进展生存期(PFS)的中位数为4.4个月(2.8 - 6.0,95%置信区间)。在总共85个BCD治疗周期中,3或4级中性粒细胞减少、血小板减少和贫血分别发生在17.6%、38.8%和16.5%的周期中。仅1例患者发生发热性中性粒细胞减少。BCD是一种对复发或难治性PTCL具有可观疗效且毒性可接受的挽救方案;符合AITL或ASCT标准的患者对BCD治疗更有效。NCT02424045。

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