肿瘤细胞治疗研究
英文原题：CAR-T versus allogeneic transplantation as consolidation for B-cell acute lymphoblastic leukemia in remission: a propensity-score matched study.
结果表明，在匹配的B-ALL患者中，CAR-T巩固方案的生存期与allo-HSCT相当，这可能支持其作为不适合allo-HSCT的B-ALL患者的一种巩固替代方案。
尽管异基因造血干细胞移植（allo-HSCT）是标准的巩固治疗，但用于缓解期B细胞急性淋巴细胞白血病（B-ALL）时仍受复发和并发症的困扰。虽然CAR-T疗法正在革新后线治疗，但其作为缓解期巩固策略的作用，尤其是对于不适合移植的患者，仍未被探索。本研究比较了CAR-T疗法与allo-HSCT作为巩固治疗对完全缓解（CR）期B-ALL患者的疗效。
一项回顾性、倾向性评分匹配研究于2012年9月1日至2024年12月31日期间进行，纳入75例接受CAR-T或allo-HSCT作为巩固治疗的B-ALL患者。针对时间-事件结局，构建了Firth惩罚似然Cox模型和限制性平均生存时间（RMST）模型。
2年无进展生存（PFS）率和2年总生存（OS）率在CAR-T与HSCT队列之间无显著差异（CR1：2年PFS率：65.8% vs. 88.9%，P = 0.146，2年OS率：83.6% vs. 91.3%，P = 0.512；CR2：2年PFS率：42.2% vs. 64.3%，P = 0.360）。PFS和OS的RMST也无显著差异（CR1：PFS的RMST差异 = -7.738，P = 0.496，OS的RMST差异 = -2.257，P = 0.788；CR2：PFS的RMST差异 = -6.176，P = 0.700，OS的RMST差异 = -8.391，P = 0.477），截断于各队列最大随访时间的最小值（CR1，74.6个月；CR2，75.0个月）。在多因素分析中，接受allo-HSCT治疗的患者在CR1组中具有更好的PFS（HR = 4.579，95%CI，1.020-20.563，P = 0.038）。高危分层是CR期B-ALL患者OS较差的独立因素（CR1：HR = 8.010；95%CI，1.744-36.781，P = 0.048；CR2 HR = 5.110，95%CI，1.167-22.378，P = 0.004）。
BACKGROUND: Despite being a standard consolidation treatment, allogeneic hematopoietic stem cell transplantation (allo-HSCT) for B-cell acute lymphoblastic leukemia (B-ALL) in remission is still hampered by relapse and complications. While CAR-T therapy is revolutionizing later-line treatment, its role as a consolidation strategy in remission, particularly for patients ineligible for transplantation, remains unexplored. This study compared the efficacy of CAR-T therapy with that of allo-HSCT as consolidation for B-ALL patients in complete remission (CR). METHODS: A retrospective, propensity-score matched study was performed from September 1, 2012 to December 31, 2024, including 75 B-ALL patients treated with CAR-T or allo-HSCT as consolidation therapy. Firth penalized likelihood Cox models and restricted mean survival time (RMST) models were built for time-to-event outcomes. RESULTS: The 2-year progression-free survival (PFS) and 2-year overall survival (OS) rates showed no significant differences between the CAR-T and HSCT cohorts (CR1: 2-year PFS rate: 65.8% vs. 88.9%, P = 0.146, 2-year OS rate: 83.6% vs. 91.3%, P = 0.512; CR2: 2-year PFS rate: 42.2% vs. 64.3%, P = 0.360). The RMSTs of PFS and OS also have no significant differences (CR1: RMST of PFS difference = -7.738, P = 0.496, RMST of OS difference = -2.257, P = 0.788; CR2: RMST of PFS difference = -6.176, P = 0.700, RMST of OS difference = -8.391, P = 0.477) truncated at the minimum of the largest follow-up times in each cohort (CR1, 74.6 months; CR2, 75.0 months). In multivariate analysis, patients treated with allo-HSCT had better PFS in CR1 group (HR = 4.579, 95%CI, 1.020-20.563, P = 0.038). High risk stratification was an independent factor associated with worse OS for B-ALL patients in CR (CR1: HR = 8.010; 95%CI, 1.744-36.781, P = 0.048; CR2 HR = 5.110, 95%CI, 1.167-22.378, P = 0.004). CONCLUSION: The results indicated that CAR-T consolidation regimen showed comparable survival to that of allo-HSCT in matched B-ALL patients, which might support its potential as a consolidation alternative for B-ALL patients ineligible for allo-HSCT.
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