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大 B 细胞淋巴瘤中的 CAR-T 细胞:基于重建患者水平数据的总生存期分析

英文原题:Chimeric Antigen Receptor T Cells in Large B-Cell Lymphoma: Analysis of Overall Survival Based on Reconstructed Patient-Level Data.

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Chimeric Antigen Receptor T Cells in Large B-Cell Lymphoma: Analysis of Overall Survival Based on Reconstructed Patient-Level Data.

PubMed 2022/12/09(内容时间) Clin Ther Q2 · IF 3.7(JCR 2025)

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研究概要

我们的结果有助于确定 CAR-T 细胞在这 2 种疾病状况中的治疗地位,并初步提示成本效果的估计。我们分析的一个优势是,间接比较中纳入的治疗方案有大量信息可用。主要不足是 Shiny 方法无法进行多变量分析。

研究思路结论见上方概要

嵌合抗原受体(CAR)T细胞产品(如 tisagenlecleucel [tisa]、axicabtagene ciloleucel [axi])已用于复发/难治性大B细胞淋巴瘤(LBCL)患者以及成人急性淋巴细胞白血病(ALL)患者。在近期LBCL长期随访数据发表后,有必要对该主题的证据进行回顾。本工作的目的是研究CAR-T 细胞产品在LBLC和ALL中报告的总生存期(OS)模式。

进行了标准文献检索。通过一种人工智能技术(Shiny法)研究OS,该技术从已发表的Kaplan-Meier曲线中重建个体患者数据。对这些重建数据进行了标准统计学分析以及间接比较。间接比较聚焦于LBCL和ALL中CAR-T 细胞与化疗的比较;在LBCL中进一步对tisa和axi进行了间接比较。

纳入7项试验(4项针对LBCL,3项针对ALL)。其他人群被选为对照组。我们分析的主要结果为:(1)CAR-T 细胞在成人ALL患者中的生存优势大于LBCL患者;(2)对于LBCL,axi相比tisa的生存获益更为显著。

展开英文摘要原文

Chimeric antigen receptor (CAR) T-cell products (eg, tisagenlecleucel [tisa], axicabtagene ciloleucel [axi]) have been used in patients with relapsed/refractory large B-cell lymphoma (LBCL) and in adult patients with acute lymphoblastic leukemia (ALL). After the recent publication of long-term follow-up data in LBCL, reviewing the evidence on this topic is worthwhile. The aim of the present work was to study the pattern of overall survival (OS) reported for CAR T-cell products in LBLC and ALL.

A standard literature search was performed. OS was studied through an artificial intelligence technique (the Shiny method) that reconstructs individual patient data from published Kaplan-Meier curves. Standard statistics along with indirect comparisons were performed on these reconstructed data. Indirect comparisons focused on CAR T cells versus chemotherapy in LBCL and ALL; tisa and axi were further indirectly compared in LBCL.

Seven trials were included (4 for LBCL, 3 for ALL). Other populations were selected as control groups. The main results of our analysis were: (1) the survival advantage of CAR T cells is greater in adult patients with ALL than in patients with LBCL; and (2) for LBCL, the survival gain is more substantial for axi compared with tisa. IMPLICATIONS: Our results are helpful to define the place in therapy of CAR T cells in these 2 disease conditions and also suggest preliminary estimates of cost-effectiveness. One strength of our analysis is that extensive information was available for the treatment options included in indirect comparisons. The main weakness is the inability of the Shiny method to perform multivariate analyses.

论文信息

作者
Messori A、Chiumente M、Mengato D
单位
HTA Unit, Regione Toscana, Firenze, Italy. Electronic address: andrea.messori.it@gmail.com.Italy
文献类型
非美国政府资助研究
期刊
Clinical therapeutics2022 Dec
原文标识
PubMed 36503735 · DOI 10.1016/j.clinthera.2022.11.002