CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：FREEDOMM: Fifth-Line or Later Real-World Evaluation of Efficacy and Disease Outcomes in Multiple Myeloma with Ciltacabtagene Autoleucel: Treatment-Free Interval and Overall Survival in the USA.
FREEDOMM: Fifth-Line or Later Real-World Evaluation of Efficacy and Disease Outcomes in Multiple Myeloma with Ciltacabtagene Autoleucel: Treatment-Free Interval and Overall Survival in the USA.
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与美国临床实践中关键试验结果一致，cilta-cel 对 RRMM 且接受过 4 线以上既往治疗（4 + pLOT）的患者有效。研究结果与既往支持 BT 有效性的结果一致。本文附有图形摘要。
Ciltacabtagene autoleucel (cilta-cel) 于 2022 年 2 月被批准用于治疗成人复发/难治性多发性骨髓瘤 (RRMM)。本研究评估了接受 cilta-cel 治疗的 RRMM 患者在接受 4 种既往治疗 (4 + pLOT) 后的美国真实世界结果，总体结果并按接受桥接治疗 (BT) 进行分层。
使用科莫多研究数据库 (01/01/2016-06/30/2024) 的索赔数据确定了在 4 + pLOT 后接受标准护理 cilta-cel 的 RRMM 成人患者。使用 Kaplan-Meier (KM) 分析评估无治疗间隔（TFI；cilta-cel 输注与开始下一次治疗或死亡之间的时间）和总生存期 (OS)。使用调整后的多变量 Cox 回归来评估接受 BT 的 TFI/OS 的风险比 (HR) 和 95% 置信区间 (CI)。
在接受 cilta-cel 治疗的 242 例患者中（平均年龄 63.4 岁，女性患者占 45.5%，男性患者占 54.5%），有 BT（75.2%）的患者比无 BT 者具有更高的合并症负担（平均 Quan-Charlson 合并症指数 5.3 vs. 4.7）和更高的衰弱指数评分（轻至重度 49.4% vs. 28.3%）。中位随访时间为 11 个月。采用 KM 方法以考虑随访时间的差异后，输注后 18 个月的估计 TFI 为 80.3%，而输注后 18 个月的 KM 估计 OS 为 93.4%。中位 TFI 或 OS 均未达到。与无 BT 的患者相比，有 BT 的患者在数值上更不易发生 TFI 事件（HR 0.76，95% CI 0.32-1.80），且更可能保持存活（HR 0.48，95% CI 0.13-1.70）。
Adults with RRMM receiving standard-of-care cilta-cel after 4 + pLOT were identified using claims data from the Komodo Research Database (01/01/2016-06/30/2024). Treatment-free interval (TFI; time between cilta-cel infusion and initiation of next treatment or death) and overall survival (OS) were evaluated using Kaplan-Meier (KM) analyses. Adjusted multivariate Cox regression was used to assess hazard ratios (HR) and 95% confidence intervals (CIs) for TFI/OS by receipt of BT.
Among 242 patients receiving cilta-cel (mean age 63.4 years, 45.5% were female patients, 54.5% were male patients), those with BT (75.2%) had a higher comorbidity burden (mean Quan-Charlson Comorbidity Index 5.3 vs. 4.7) and higher frailty index score (mild-to-severe 49.4% vs. 28.3%) than those without. The median follow-up was 11 months. Using KM methods to account for variable follow-up, the estimated TFI at 18 months post-infusion was 80.3%, while the KM estimate of OS at 18 months post-infusion was 93.4%. Median TFI or OS was not reached. Patients with BT were numerically less likely to have a TFI event (HR 0.76, 95% CI 0.32-1.80) and more likely to remain alive (HR 0.48, 95% CI 0.13-1.70) relative to those without BT.
Consistent with pivotal trials, cilta-cel was effective in patients with RRMM and 4 + pLOT in US clinical practice. Findings align with previous results supporting BT effectiveness. Graphical abstract available for this article.
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