肿瘤细胞治疗研究
英文原题：Clinical outcomes with ciltacabtagene autoleucel among patients with relapsed/refractory multiple myeloma after four or more prior lines of therapy overall and among subgroups based on age, frailty, and CRAB symptoms.
Clinical outcomes with ciltacabtagene autoleucel among patients with relapsed/refractory multiple myeloma after four or more prior lines of therapy overall and among subgroups based on age, frailty, and CRAB symptoms.
本研究表明，在临床实践中，既往接受过4线治疗的RRMM患者接受cilta-cel治疗后获得了良好的结局，包括年龄较大、衰弱指数评分较高以及近期出现CRAB症状的患者。
西达基奥仑赛（cilta-cel）是一种靶向B细胞成熟抗原的CAR-T 细胞疗法，在复发/难治性多发性骨髓瘤（RRMM）的临床试验中已显示出深度且持久的缓解。本研究旨在对接受cilta-cel治疗的患者在临床实践中的结局进行描述性评估，包括根据可能影响结局的患者特征划分的亚组。
这项回顾性研究使用了Loopback Analytics电子病历（2021年2月至2025年6月）来识别在接受4线既往治疗（LOT）后接受cilta-cel治疗的RRMM成人患者。索引日期定义为cilta-cel输注日期。作为无进展生存期的替代结局，无治疗间期（TFI）定义为从输注到最早开始下一治疗或死亡的时间。总生存期（OS）定义为从输注到死亡的时间。为了更准确地识别接受下一LOT的患者，下一治疗日期定义为输注后60天时符合条件药物的最早配药或给药日期，前提是患者有2次同一药物的配药或给药记录。Kaplan-Meier分析评估了所有患者以及按年龄（75岁）、输注前三个月内的衰弱指数评分（轻度至重度衰弱）和输注前一个月内的CRAB症状（高钙血症、肾功能损害、贫血或骨病变；1种症状）定义的亚组中的TFI和OS。
在203例患者中，8.4%年龄为75岁，14.8%为轻度至重度衰弱，38.4%有1个CRAB症状。中位（四分位距）随访时间为17.6（12.0-24.2）个月。对于TFI，输注后12个月和18个月的估计Kaplan-Meier率（95%置信区间）分别为85.5%（79.6%-89.8%）和76.5%（69.0%-82.4%），而OS率分别为95.1%（90.8%-97.4%）和93.0%（87.8%-96.0%）。在各亚组中，TFI总体上与总体人群保持一致，OS仍保持较高水平。
BACKGROUND: Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy, has shown deep and durable responses in clinical trials for relapsed/refractory multiple myeloma (RRMM). This study aimed to provide a descriptive evaluation of outcomes among patients who received cilta-cel in clinical practice, including among subgroups based on patient characteristics that could impact outcomes. METHODS: This retrospective study used Loopback Analytics electronic medical records (02/2021-06/2025) to identify adults with RRMM who received cilta-cel after 4 prior lines of therapy (LOT). The index date was defined as the cilta-cel infusion date. As a surrogate outcome for progression-free survival, treatment-free interval (TFI) was defined as the time from infusion to the earliest of initiation of next treatment or death. Overall survival (OS) was defined as the time from infusion to death. To more accurately identify patients with a next LOT, the date of next treatment was defined as the earliest fill or administration for an eligible agent 60 days post-infusion, provided that the patient had 2 fills or administrations of the same agent. Kaplan-Meier analyses assessed TFI and OS in all patients and by subgroups defined by age ( 75 years), frailty index score (mild-to-severe frailty) in the three months pre-infusion, and CRAB symptoms (hypercalcemia, renal impairment, anemia, or bone lesions; 1 symptom) in the one month pre-infusion. RESULTS: Among 203 patients, 8.4% were aged 75 years, 14.8% were mildly-to-severely frail, and 38.4% had 1 CRAB symptom. Median (interquartile range) follow-up was 17.6 (12.0-24.2) months. For TFI, the estimated Kaplan-Meier rates (95% confidence interval) at 12 and 18 months post-infusion were 85.5% (79.6%-89.8%) and 76.5% (69.0%-82.4%), respectively, while the OS rates were 95.1% (90.8%-97.4%) and 93.0% (87.8%-96.0%). Across subgroups, TFI remained generally consistent with the overall population and OS remained high. CONCLUSIONS: This study demonstrated favorable outcomes among patients with RRMM who received cilta-cel after 4 prior LOT in clinical practice, including among patients with older age, higher frailty index score, and recent presence of CRAB symptoms.
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