Jiangxi Provincial Key Laboratory of Hematological Diseases, Department of Hematology, The 2nd Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi, China.
Front Immunol. 2024 Sep 6;15:1435127. doi: 10.3389/fimmu.2024.1435127. eCollection 2024.
Chimeric antigen receptor (CAR) T-cell therapy (CAR-T therapy) has demonstrated significant efficacy in the ZUMA-2 study. After regulatory approvals, several clinical trials and real-world studies on CAR-T therapy for relapsed or refractory mantle cell lymphoma (R/R MCL) were conducted. However, data on clinical safety and efficacy are inconsistent. In this study, we aimed to conduct a systematic analysis of the effectiveness and safety of CAR-T therapy across a wider and more representative cohort of patients with R/R MCL.
We performed a systematic review and meta-analysis of studies on patients with R/R MCL who received CAR-T cell therapy. Data were extracted and consolidated, with primary focus on the evaluation of safety and efficacy outcome measures. This study has not been registered with PROSPERO.
This meta-analysis identified and included 16 studies with 984 patients. The pooled estimate for overall response rate (ORR) was 89%; complete remission (CR) rate was 74%. The 6-month and 12-month progression-free survival (PFS) rates were 69% and 53%, respectively, while the overall survival (OS) rates were 80% and 69%, respectively. Cytokine release syndrome (CRS) of grade 3 or higher was observed in 8% of patients, whereas neurotoxicity of grade 3 or higher was observed in 22% of patients. The risk of bias was assessed as low in 9 studies and moderate in 7 studies.
CAR-T therapy exhibited promising efficacy and manageable adverse reactions in patients with R/R MCL.
嵌合抗原受体（CAR）T 细胞疗法（CAR-T 疗法）在 ZUMA-2 研究中显示出显著疗效。监管批准后，针对复发或难治性套细胞淋巴瘤（R/R MCL）的 CAR-T 疗法进行了几项临床试验和真实世界研究。然而，关于 CAR-T 疗法的临床安全性和疗效的数据不一致。在这项研究中，我们旨在对更广泛和更具代表性的 R/R MCL 患者队列中 CAR-T 疗法的有效性和安全性进行系统分析。
我们对接受 CAR-T 细胞治疗的 R/R MCL 患者的研究进行了系统评价和荟萃分析。提取并整合了数据，主要侧重于评估安全性和疗效结局指标。本研究未在 PROSPERO 上注册。
这项荟萃分析确定并纳入了 16 项研究，共 984 例患者。总体缓解率（ORR）的汇总估计值为 89%；完全缓解（CR）率为 74%。6 个月和 12 个月无进展生存率（PFS）分别为 69%和 53%，而总生存率（OS）分别为 80%和 69%。有 8%的患者发生 3 级或更高级别的细胞因子释放综合征（CRS），有 22%的患者发生 3 级或更高级别的神经毒性。9 项研究的偏倚风险评估为低，7 项研究的偏倚风险评估为中。
CAR-T 疗法在 R/R MCL 患者中表现出有前景的疗效和可管理的不良反应。
