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真实世界中 polatuzumab vedotin 联合 bendamustine 与 rituximab 治疗复发/难治性弥漫大 B 细胞淋巴瘤患者

英文原题:Polatuzumab vedotin plus bendamustine and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma in the real world.

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Polatuzumab vedotin plus bendamustine and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma in the real world.

PubMed 2022/05/11(内容时间) Eur J Haematol Q2 · IF 2.6(JCR 2025)

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研究概要

尽管患者结局比 GO29365 试验更差,但真实世界中 Pola-BR 方案的应用显示,在不适合移植的复发/难治性弥漫大 B 细胞淋巴瘤患者中具有可耐受的毒性特征和疗效。

中文摘要

维泊妥珠单抗维多汀联合苯达莫司汀和利妥昔单抗(Pola-BR)已获批用于不适合移植的复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)患者。然而,GO29365试验及其扩展队列纳入患者数量有限,仍需更多数据评估该方案疗效。

分析21例R/R DLBCL患者,评估Pola-BR方案在真实世界中的疗效和安全性。所有患者数据均录入NiHiL项目数据库(NCT03199066)。

总生存期中位数为8.7个月,无进展生存期中位数为3.8个月,总缓解率为33%。3~4级中性粒细胞减少发生率为29%,血小板减少为38%,贫血为19%,感染为24%,周围神经病变为5%。治疗中断原因包括疾病进展(50%)、不良事件(31%)及计划将患者桥接至CAR-T 治疗(19%)。

尽管该真实世界队列患者结局不如GO29365试验,但Pola-BR方案在不适合移植的R/R DLBCL患者中显示出可耐受的毒性特征和一定疗效。此外,该方案可能是桥接CAR-T 治疗的一种选择。

展开英文摘要原文

Polatuzumab vedotin with bendamustine and rituximab (Pola-BR) was approved for treatment of transplant-ineligible patients with relapsed/refractory DLBCL (R/R DLBCL). However, the number of patients treated in the GO29365 trial including the extension cohort was limited, and more data evaluating the efficacy of this treatment regimen is needed.

We analyzed 21 patients with R/R DLBCL to determine real-life efficacy and safety of Pola-BR regimen. Data of all patients entered the database of the NiHiL project (NCT03199066).

Median overall survival was 8.7 months, and progression-free survival 3.8 months. The overall response rate was 33%. Grade 3-4 neutropenia was detected in 29%, thrombocytopenia in 38%, anemia in 19%, infections in 24% cases, and peripheral neuropathy in 5%. Discontinuation of treatment was caused by progression in 50%, adverse events in 31%, and intended bridging to CAR-T therapy in 19%.

Although the outcome of patients is worse than in GO29365 trial, the use of Pola-BR regimen in the real world demonstrates tolerable toxicity profile and efficacy in transplant-ineligible patients with R/R DLBCL. Moreover, this regimen might represent a perspective option as a bridge to CAR-T therapy.

论文信息

作者
Vodicka P、Benesova K、Janikova A、Prochazka V、Belada D、Mocikova H、Steinerova K、Duras J
单位
First Department of Medicine, Charles University and General University Hospital, Prague, Czech Republic.Czechia
文献类型
临床试验
期刊
European journal of haematology2022 Aug
原文标识
PubMed 35502609 · DOI 10.1111/ejh.13784