肿瘤细胞治疗研究
英文原题：The Great Debate: CAR-T-Cell Therapy Versus Bispecific Antibodies in B-Cell Lymphoma.
The Great Debate: CAR-T-Cell Therapy Versus Bispecific Antibodies in B-Cell Lymphoma.
背景：随着靶向CD19的CAR-T 细胞疗法和CD20 CD3双特异性抗体（BsAbs）的出现，复发/难治性（R/R）大B细胞淋巴瘤（LBCL）的治疗模式已发生重大变化。
背景：随着CD19靶向CAR-T 细胞疗法和CD20 CD3双特异性抗体（BsAbs）的出现，复发/难治性（R/R）大B细胞淋巴瘤（LBCL）的治疗范式已发生重大变化。尽管两种方法在单臂研究中均显示出高缓解率，但缺乏前瞻性随机头对头比较，导致真正的临床均势。 方法：进行了叙述性综合，纳入了关键性及更新的2期和3期试验数据、真实世界证据以及已发表的荟萃分析。 结果：在二线治疗中，与标准治疗化疗-移植方案相比，CAR-T疗法显示出更优的无事件生存期、无进展生存期和总生存期。在三线治疗中，一项汇总荟萃分析表明，与BsAbs相比，CAR-T的完全缓解率显著更高，12个月无进展生存期也更优。BsAbs可即时可用、可及性更高、神经毒性特征更有利，并且对体弱或老年患者可行。真实世界数据显示，BsAb的完全缓解率始终低于临床试验中观察到的结果，而CAR-T的真实世界疗效与关键性试验结果高度一致。关于固定疗程和单药双特异性方案的新兴3期数据表明，在BsAb治疗的完全缓解者中，也可能实现真正的、尽管尚不成熟的治愈比例。 结论：对于适合且符合条件的R/R LBCL患者，CAR-T疗法仍是二线和三线治疗中具有治愈意图的标准治疗，提供更优的缓解深度和持久性，以及日益增长的长期治愈潜力。BsAb 是 CAR-T 不合格患者、疾病快速进展患者、体弱或老年个体以及作为桥接策略的关键治疗替代方案。推荐采用以患者为中心、针对具体场景的临床决策框架。
Background: The treatment paradigm for relapsed/refractory (R/R) large B-cell lymphoma (LBCL) has undergone significant change with the advent of CD19-directed chimeric antigen receptor T-cell (CAR-T) therapies and CD20 CD3 bispecific antibodies (BsAbs). Although both approaches have shown high response rates in single-arm studies, the absence of prospective randomized head-to-head comparisons has resulted in true clinical equipoise. Methods: A narrative synthesis was conducted, incorporating pivotal and updated phase 2 and 3 trial data, real-world evidence, and published meta-analyses. Results: In the second-line setting, CAR-T therapy demonstrates superior event-free survival, progression-free survival, and overall survival compared to standard-of-care chemo-transplant regimens. In the third-line setting, a pooled meta-analysis indicates significantly higher complete response rates for CAR-T compared with BsAbs, as well as superior 12-month progression-free survival. BsAbs provide immediate availability, greater accessibility, more favorable neurotoxicity profiles, and are feasible for frail or elderly patients. Real-world data show that BsAb complete response rates are consistently lower than those observed in clinical trials, whereas CAR-T real-world effectiveness closely aligns with pivotal trial outcomes. Emerging phase 3 data on fixed-duration and monotherapy bispecific regimens suggest that a genuine, if less mature, curative fraction may also be achievable among BsAb-treated complete responders. Conclusions: CAR-T therapy remains the standard of care for fit, eligible patients with R/R LBCL in second- and third-line settings with curative intent, providing superior depth and durability of response and a growing potential for long-term cure. BsAbs constitute a critical therapeutic alternative for patients ineligible for CAR-T, those with rapidly progressive disease, frail or elderly individuals, and as bridging strategies. A patient-centered, scenario-specific clinical decision framework is recommended.
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