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CAR-T 细胞治疗复发/难治性 B 细胞非霍奇金淋巴瘤的真实世界证据:单中心经验

英文原题:Real World Evidence of CAR T-Cell Therapies for the Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma: A Monocentric Experience.

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Real World Evidence of CAR T-Cell Therapies for the Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma: A Monocentric Experience.

PubMed 2021/09/24(内容时间) Cancers (Basel) Q2 · IF 4.8(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

中文摘要

大B细胞淋巴瘤(LBCL)是非霍奇金淋巴瘤最常见的类型。尽管由于引入了以利妥昔单抗为基础的化学免疫治疗,预后有所改善,但某些LBCL由于初始治疗耐药或反复复发,仍然是一个挑战。Axicabtagene ciloleucel(axi-cel)和tisagenlecleucel(tisa-cel)是第二代自体CD19靶向嵌合抗原受体(CAR)T细胞疗法,基于II期关键性单臂试验ZUMA-1(针对axi-cel)和JULIET(针对tisa-cel)的结果,获批用于复发/难治性(R/R)LBCL患者。

在此,我们报告了在我们机构接受axi-cel和tisa-cel标准治疗(SoC)的R/R LBCL患者的结局。数据收集自2019年8月至2021年2月期间接受白细胞采集的患者。毒性根据机构指南进行分级和管理。疗效根据Lugano 2014分类进行评估。在30例接受白细胞采集的患者中,18例(60%)接受了axi-cel,而12例(40%)接受了tisa-cel。3级或以上细胞因子释放综合征和神经毒性分别发生于10%和16%的患者。最佳客观缓解率和完全缓解率分别为73.3%和40%。在SoC环境下使用CD19 CAR-T 细胞疗法治疗R/R LBCL显示出可控的安全性特征和高客观缓解率。

展开英文摘要原文

Large B-cell lymphomas (LBCL) are the most common types of non-Hodgkin lymphoma. Although outcomes have improved thanks to the introduction of rituximab-based chemoimmunotherapy, certain LBCL still represents a challenge because of initial resistance to therapy or recurrent relapses.

Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are second-generation autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapies approved for patients with relapsed/refractory (R/R) LBCL, based on the results of phase II pivotal single-arm trials ZUMA-1 (for axi-cel) and JULIET (for tisa-cel).

Here, we report patients outcomes with axi-cel and tisa-cel in the standard of care (SoC) setting for R/R LBCL, treated at our Institution. Data were collected from patients who underwent leukapheresis between August 2019 and February 2021. Toxicities were graded and managed according to the institution's guidelines. Responses were assessed as per Lugano 2014 classification.

Of the 30 patients who underwent leukapheresis, 18 (60%) received axi-cel, while 12 (40%) tisa-cel. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 10% and 16% patients, respectively. Best objective and complete response rates were 73. 3% and 40%, respectively. Treatment in SoC setting with CD19 CAR T-cell therapies for R/R LBCL showed a manageable safety profile and high objective response rate.

论文信息

作者
Casadei B、Argnani L、Guadagnuolo S、Pellegrini C、Stefoni V、Broccoli A、Nanni L、Morigi A
单位
Istituto di Ematologia "Seràgnoli", IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.Italy
期刊
Cancers2021 Sep 24
原文标识
PubMed 34638273 · DOI 10.3390/cancers13194789