CELL INTELLIGENCE · 肿瘤细胞治疗研究

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意向性治疗与改良意向性治疗分析在 BCMA 和 CD19 嵌合抗原受体试验中的比较：一项系统评价和 meta 分析

英文原题：Intention to treat versus modified intention-to-treat analysis in B-cell maturation antigen and CD19 chimeric antigen receptor trials: A systematic review and meta-analysis.

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Intention to treat versus modified intention-to-treat analysis in B-cell maturation antigen and CD19 chimeric antigen receptor trials: A systematic review and meta-analysis.

PubMed 2021/08/26（内容时间） Eur J Cancer Q1 · IF 7.9（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。

靶点：CD19靶点：BCMA技术：CAR-T淋巴瘤地区：美国
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研究概要

在 BCMA 和 CD19 CAR-T 试验中，改良分析与 iTT 分析之间的 ORR 差异高达 8-12%，并且关于患者未接受预期研究治疗的原因信息匮乏。

研究思路结论见上方概要

背景

CAR-T 细胞疗法（CAR-T）已彻底改变了血液系统恶性肿瘤的治疗；然而，目前的报告使用改良意向性治疗分析（mITT），这高估了疗效。我们通过对mITT和意向性治疗（iTT）总体缓解率（ORR）进行荟萃分析，评估了CD19和B细胞成熟抗原（BCMA）CAR-T 试验中报告入组后未接受CAR-T 的患者数量的比例。

方法

检索了PubMed/MEDLINE、EMBASE和Cochrane数据库。纳入2013年1月1日至2020年11月1日期间所有针对CD19和BCMA靶向CAR-T、招募2名或以上患者的前瞻性临床试验。

结果

共识别出28项BCMA CAR-T 试验和74项CD19 CAR-T 试验。其中，10项BCMA CAR-T 试验（35.7%）和52项CD19 CAR-T 试验（70.2%）报告了入组患者总数及接受CAR-T 治疗的患者数。对于该试验队列，BCMA CAR-T 的mITT ORR为78.0%（95% CI = 67.0-89.0%），iTT ORR为70.0%（95% CI = 59.0-80.0%）。对于CD19白血病CAR-T，mITT ORR为87.2%（95% CI = 83.1-91.2），iTT ORR为74.9（95% CI = 64.8-85.0）。对于CD19淋巴瘤CAR-T，mITT ORR为70.7%（95% CI = 63.9-77.5），iTT ORR为58.7%（95% CI = 49.7-67.7）。

展开英文摘要原文
METHODS

PubMed/MEDLINE, EMBASE and Cochrane databases were searched. All prospective clinical trials of CD19 and BCMA-targeting CART enrolling two or greater patients from 1st January 2013 to 1st November 2020 were included.

RESULTS

A total of 28 BCMA CART and 74 CD19 CART trials were identified. These included 10 BCMA CART (35.7%) and 52 (70.2%) CD19 CART trials reporting total number of patients enrolled and number of patients treated with CART. For this cohort of trials, the mITT ORR for BCMA CART was 78.0% (95% confidence interval (CI) = 67.0-89.0%), and the iTT ORR was 70.0% (95% CI = 59.0-80.0%). For CD19 leukaemia CART, the mITT ORR was 87.2% (95% CI = 83.1-91.2), and the iTT ORR was 74.9 (95% CI = 64.8-85.0). For CD19 lymphoma CART, the mITT ORR was 70.7% (95% CI = 63.9-77.5), and the iTT ORR was 58.7% (95% CI = 49.7-67.7).

CONCLUSION

Across BCMA and CD19 CART trials, there is a difference of up to 8-12% in the ORR between modified and iTT analyses and a paucity of information regarding reasons why patients did not receive the intended study treatment.

论文信息

作者
Mohyuddin GR、Atieh T、Ahmed N、Sborov D、McClune B、Abdallah AO、Goodman AM、Aziz M
单位
Division of Hematology and Hematological Malignancies, University of Utah, United States. Electronic address: g.mohyuddin@hci.utah.edu.United States
文献类型
荟萃分析 · 系统综述
期刊
European journal of cancer (Oxford, England : 1990)2021 Oct
原文标识
PubMed 34454318　·　DOI 10.1016/j.ejca.2021.07.036

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