肿瘤细胞治疗研究
英文原题：Meta-analysis of comparing CAR-T and bispecific antibody therapy in relapsed/refractory indolent B-cell non-Hodgkin's lymphomas.
与双特异性抗体相比，CAR-T 疗法在 R/R 惰性 B-NHL 中提供了更优的疗效和生存，但不良事件增加，这凸显了仔细筛选患者和进行毒性管理的必要性。
背景：惰性B细胞非霍奇金淋巴瘤（B-NHL），包括滤泡性淋巴瘤（FL）和边缘区淋巴瘤（MZL），通常进展缓慢，但接受常规治疗后常呈复发缓解过程。CAR-T 细胞和双特异性抗体（BsAb）疗法已革新复发/难治性（R/R）B-NHL的治疗，但在惰性B-NHL中直接比较二者疗效的数据仍有限。本荟萃分析系统评估两种创新疗法用于R/R FL和MZL患者的疗效与安全性。方法：检索MEDLINE、Embase、Cochrane对照试验注册库及国际会议摘要（截至2025年6月30日），纳入评估CAR-T或BsAb治疗R/R FL和MZL的研究。主要结局为合并完全缓解（CR）率；其他结局包括2年无进展生存期（PFS）、2年总生存期（OS）、非复发死亡（NRM）及不良事件（AE）。采用荟萃回归校正相关临床协变量。结果：共纳入19篇研究（1,760例患者），其中CAR-T研究10项、BsAb研究9项。单臂荟萃分析显示，与BsAb相比，CAR-T疗效更优：合并CR率为80.73%比67.14%（p=0.0003），2年PFS为68.84%比47.71%（p=0.0006），2年OS为88.37%比75.26%（p=0.049）。两种疗法每100人年NRM相近（3.89比3.86，p=0.9871）。CAR-T的获益在三线及以后治疗中仍存在，在仅纳入临床试验数据的分析中也一致。多变量荟萃回归证实，CR方面CAR-T的优势独立于中位年龄。安全性分析显示，CAR-T组3级神经毒性（7.48%比0.23%，p=0.0029）、中性粒细胞减少（58.90%比26.21%，p=0.007）和血小板减少（16.77%比5.00%，p=0.005）发生率较高，但每100人月3级感染发生率较低（0.38比0.91，p=0.040）。两组3级CRS或贫血发生率无差异。结论：与BsAb相比，CAR-T可为R/R惰性B-NHL带来更优疗效和生存，但不良事件增加，因此需谨慎选择患者并管理毒性。
BACKGROUND: Indolent B-cell non-Hodgkin s lymphomas (B-NHLs), including follicular lymphoma (FL) and marginal zone lymphoma (MZL), typically demonstrate slow progression but frequently follow a relapsing-remitting course with conventional therapies. Chimeric antigen receptor T-cell (CAR-T) and bi-specific antibodies (BsAbs) therapies have revolutionized treatment for relapsed/refractory (R/R) B-NHLs. However comparative data on the efficacy of CAR-T therapy versus BsAbs in indolent B-NHLs remain limited. This meta-analysis systematically evaluated the efficacy and safety profiles of these two innovative treatments in patients with R/R FL and MZL. METHODS: We conducted a comprehensive search of MEDLINE, Embase, Cochrane Central Register of Controlled Trial databases, and international conference abstracts (through June 30, 2025) for studies investigating CAR-T or BsAb therapies in R/R FL and MZL. Primary outcome was pooled complete response (CR) rate. Other outcomes included 2-year progression-free survival (PFS), 2-year overall survival (OS), non-relapse mortality (NRM), and adverse events (AEs). Meta-regression analyses were performed to adjust for relevant clinical covariates. RESULTS: Our analysis included 19 publications (n = 1,760 patients), comprising 10 CAR-T and 9 BsAbs studies. The single-arm meta-analysis showed that CAR-T therapy demonstrated superior efficacy, with higher pooled CR rate (80.73% vs. 67.14%; p = 0.0003), 2-year PFS (68.84% vs. 47.71%; p = 0.0006), and 2-year OS (88.37% vs. 75.26%; p = 0.049) compared to BsAbs. NRM per 100 person-years was similar between two modalities (3.89 vs 3.86, p = 0.9871). CAR-T benefits persisted in third-line or later settings, as well as in analyses restricted to clinical trial data. Multivariate meta-regression confirmed CAR-T s superiority for CR independent of median age. Safety analysis revealed CAR-T group had higher incidence of grade 3 neurotoxicity (7.48% vs. 0.23%, p = 0.0029), neutropenia (58.90% vs. 26.21%; p = 0007), thrombocytopenia (16.77% vs. 5.00%; p = 0.005), but lower incidence of grade 3 infection per 100 person-months (0.38 vs. 0.91, p = 0.040) than BsAb group. No differences were observed in grade 3 cytokine release syndrome or anemia. CONCLUSION: CAR-T therapy offered superior efficacy and survival in R/R indolent B-NHLs compared to BsAbs, albeit with increased AEs, highlighting the need for careful patient selection and toxicity management.
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