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CAR-T 细胞治疗作为大 B 细胞淋巴瘤二线治疗优于标准治疗:一项系统综述与荟萃分析

英文原题:Chimeric antigen receptor T-cell therapy is superior to standard of care as second-line therapy for large B-cell lymphoma: A systematic review and meta-analysis.

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Chimeric antigen receptor T-cell therapy is superior to standard of care as second-line therapy for large B-cell lymphoma: A systematic review and meta-analysis.

PubMed 2022/06/28(内容时间) Br J Haematol Q2 · IF 3.6(JCR 2025)

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中文摘要

大剂量化疗后自体干细胞移植(ASCT)被视为复发/难治性大B细胞淋巴瘤(LBCL)的标准二线治疗,但结局仍未理想。本研究系统综述和荟萃分析随机对照试验,比较标准治疗(SOC)与CAR-T 细胞作为难治或12个月内复发LBCL患者二线治疗的疗效和安全性。结局包括总生存期(OS)、无事件生存期(EFS)、总缓解率(ORR)和安全性。2021年发表的3项试验(共865名参与者)符合纳入标准。与SOC相比,CAR-T 显著改善EFS和OS,风险比分别为0.57(95%置信区间0.49–0.68)和0.77(95%置信区间0.60–0.98)。CAR-T 的ORR也显著较高,相对风险为1.55(95%置信区间1.12–2.13,P=0.001)。两组III/IV级不良事件风险相近(相对风险1.03,95%置信区间0.93–1.14)。

总之,对于12个月内复发或难治LBCL患者,CAR-T 疗效优于SOC且毒性未增加。仍需更长随访以确认结果,并确定CAR-T 在LBCL管理中的最佳治疗顺序。

展开英文摘要原文

Treatment with high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is considered standard of care (SOC) second-line treatment for relapsed or refractory large B-cell lymphoma (LBCL).

However, outcomes remain suboptimal. A systematic review and meta-analysis of randomised controlled trials comparing efficacy and safety of SOC versus chimeric antigen receptor T-cell (CAR-T) therapy as second-line for patients with LBCL refractory or relapsing within 12 months. Outcomes included overall survival (OS), event-free survival (EFS), overall response rate (ORR) and safety. Three trials published in 2021 (involving 865 participants) fulfilled the eligibility criteria. EFS as well as OS were significantly improved with CAR-T therapy as compared to SOC, hazard ratio (HR) 0.

57 (95% confidence interval [CI] 0. 49-0. 68) and HR 0. 77 (95% CI 0. 60-0. 98) respectively. CAR-T therapy was associated with significantly better ORR, relative risk (RR) 1. 55 (95% CI 1. 12-2. 13, p = 0. 001). The risk of Grade III/IV adverse event was comparable between the two arms, RR 1. 03 (95% CI 0.

93-1. 14). In summary, CAR-T therapy has superior outcomes as compared to SOC in patients with LBCL refractory or relapsing within 12 months, without excess of toxicity. Longer follow-up is needed to confirm these results and determine the optimal sequencing of CAR-T therapy in the management of LBCL.

论文信息

作者
Shargian L、Raanani P、Yeshurun M、Gafter-Gvili A、Gurion R
单位
Institute of Haematology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel.Israel
文献类型
荟萃分析 · 系统综述 · 非美国政府资助研究
期刊
British journal of haematology2022 Sep
原文标识
PubMed 35765220 · DOI 10.1111/bjh.18335