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Axicabtagene Ciloleucel 与 Tisagenlecleucel 在欧洲大 B 细胞淋巴瘤患者中的疗效和毒性比较:系统综述与荟萃分析

英文原题:Comparative efficacy and toxicity of Axicabtagene Ciloleucel versus Tisagenlecleucel in European patients with large B-cell lymphoma: a systematic review and meta-analysis.

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Comparative efficacy and toxicity of Axicabtagene Ciloleucel versus Tisagenlecleucel in European patients with large B-cell lymphoma: a systematic review and meta-analysis.

PubMed 2026/07/06(内容时间) PeerJ Q2 · IF 2.9(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。

研究概要

在 LBCL 欧洲患者中,Axi-cel 相比 Tisa-cel 表现出更优的短期疗效,但在某些中期疗效终点上表现较差,且通常与更大的毒性和更高的医疗资源利用相关。CAR-T 方案的选择应个体化,需仔细权衡疗效、毒性和成本。未来需要随访时间更长的高质量研究来评估长期结局并验证本分析的结果。

研究思路结论见上方概要

大B细胞淋巴瘤(LBCL)是一种常见且侵袭性强的非霍奇金淋巴瘤(NHL),以成熟B淋巴细胞异常增殖为特征,在欧洲人群中10年患病率高达每10万人45例,且呈持续上升趋势。Axicabtagene ciloleucel(Axi-cel)和Tisagenlecleucel(Tisa-cel)是两种最成熟的用于LBCL的CAR-T 细胞治疗产品,然而在欧洲人群中对其疗效和安全性的系统比较一直缺乏。本系统综述和meta分析旨在通过全面评估Axi-cel与Tisa-cel在欧洲LBCL患者中治疗效果和不良事件的差异来填补这一空白。

我们检索了PubMed、Cochrane Library、Scopus及其他数据库,纳入2020年1月至2026年2月间发表的研究,最终纳入8项欧洲队列研究,共2,178例患者。疗效和生存结局包括3个月总体缓解(OR)、3个月完全缓解(CR)、12个月无进展生存期(PFS)和12个月总生存期(OS)。毒性结局包括12个月非复发死亡率(NRM)、所有级别和3级细胞因子释放综合征(CRS)、所有级别和3级免疫效应细胞相关神经毒性综合征(ICANS)、所有级别和3级中性粒细胞减少、血小板减少和贫血,以及托珠单抗使用和ICU支持。采用随机效应模型进行汇总分析,对存在显著异质性的结局进行敏感性分析。

在疗效方面,与Tisa-cel相比,Axi-cel与显著更高的3个月OR率和3个月CR率相关,而Axi-cel组的12个月PFS较低。在毒性方面,Axi-cel的all-grade CRS、all-grade ICANS和grade 3 ICANS发生率显著更高,且tocilizumab使用更频繁。其余结局未观察到统计学显著差异。

展开英文摘要原文

We searched PubMed, Cochrane Library, Scopus, and other databases for studies published between January 2020 and February 2026, ultimately including eight European cohort studies with a total of 2,178 patients. Efficacy and survival outcomes comprised 3-month overall response (OR), 3-month complete response (CR), 12-month progression-free survival (PFS), and 12-month overall survival (OS). Toxicity outcomes included 12-month non-relapse mortality (NRM), all-grade and grade 3 cytokine release syndrome (CRS), all-grade and grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), all-grade and grade 3 neutropenia, thrombocytopenia, and anemia, as well as tocilizumab use and ICU support. A random-effects model was used for pooled analysis, with sensitivity analyses performed for outcomes exhibiting substantial heterogeneity.

Regarding efficacy, Axi-cel was associated with significantly higher 3-month OR and 3-month CR rates compared with Tisa-cel, whereas 12-month PFS was lower in the Axi-cel group. In terms of toxicity, the incidences of all-grade CRS, all-grade ICANS, and grade 3 ICANS were significantly higher with Axi-cel, and tocilizumab use was more frequent. No statistically significant differences were observed for the remaining outcomes.

In European patients with LBCL, Axi-cel demonstrated superior short-term efficacy compared with Tisa-cel, but showed inferior performance on certain intermediate-term efficacy endpoints and was generally associated with greater toxicity and higher healthcare resource utilization. Clinical selection of a CAR-T regimen should be individualized, with careful consideration of efficacy, toxicity, and cost. Future high-quality studies with longer follow-up are needed to evaluate long-term outcomes and to validate the findings of this analysis.

论文信息

作者
Li H、Liu Y、Wang T、Zhong K、Xiao J、Huang X
第一作者单位
School of Basic Medicine, Capital Medical University, Beijing, China.China
通讯作者单位
Beijing Shijitan Hospital, Capital Medical University, Beijing, China.China
文献类型
系统综述 · 荟萃分析 · 对照研究
期刊
PeerJ2026
原文标识
PubMed 42428526 · DOI 10.7717/peerj.21410