肿瘤细胞治疗研究
英文原题：Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma.
Indirect treatment comparison of brexucabtagene autoleucel (ZUMA-2) versus standard of care (SCHOLAR-2) in relapsed/refractory mantle cell lymphoma.
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SCHOLAR-2回顾性研究显示，既往接受共价布鲁顿酪氨酸激酶抑制剂（BTKi）失败的复发/难治性（R/R）套细胞淋巴瘤（MCL）患者接受标准治疗（SOC）后的总生存期（OS）较差。ZUMA-2单臂试验中，既往接受BTKi治疗的R/R MCL患者使用自体抗CD19 CAR-T 疗法布瑞基奥仑赛（brexu-cel）后，获得较高比例持久应答。
本研究采用三种调整人群间预后因素失衡的方法，比较ZUMA-2与SCHOLAR-2的OS：逆概率加权（IPW）、回归调整（RA）及双重稳健（DR）分析。无论未经调整还是调整后比较，brexu-cel均与较SOC改善OS相关。各方法估算的风险比（95%置信区间）分别为：IPW 0.38（0.23–0.61）、RA 0.45（0.28–0.74）、DR 0.37（0.23–0.59）。结果提示，对于既往接受BTKi治疗的R/R MCL患者，与SOC相比，brexu-cel可带来显著生存获益。
The SCHOLAR-2 retrospective study highlighted poor overall survival (OS) with standard of care (SOC) regimens among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) who failed a covalent Bruton tyrosine kinase inhibitor (BTKi). In the ZUMA-2 single-arm trial, brexucabtagene autoleucel (brexu-cel; autologous anti-CD19 CAR T-cell therapy) demonstrated high rates of durable responses in patients with R/R MCL who had previous BTKi exposure.
Here, we compared OS in ZUMA-2 and SCHOLAR-2 using three different methods which adjusted for imbalances in prognostic factors between populations: inverse probability weighting (IPW), regression adjustment (RA), and doubly robust (DR). Brexu-cel was associated with improved OS compared to SOC across all unadjusted and adjusted comparisons.
Hazard ratios (95% confidence intervals) were 0. 38 (0. 23, 0. 61) for IPW, 0. 45 (0. 28, 0. 74) for RA, and 0. 37 (0. 23, 0. 59) for DR. These results suggest a substantial survival benefit with brexu-cel versus SOC in patients with R/R MCL after BTKi exposure.
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