CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Meta-analysis of ciltacabtagene autoleucel versus physician's choice therapy for the treatment of patients with relapsed or refractory multiple myeloma.
Meta-analysis of ciltacabtagene autoleucel versus physician's choice therapy for the treatment of patients with relapsed or refractory multiple myeloma.
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由于缺乏头对头试验，既往已将ciltacabtagene autoleucel（cilta-cel；CARTITUDE-1试验）与真实世界临床实践中使用的治疗（医生选择治疗，PCT）进行间接治疗比较（ITC）。我们利用现有ITC数据开展多项荟萃分析，综合评估cilta-cel相较于PCT治疗三类药物暴露的复发/难治性多发性骨髓瘤（RRMM）患者的疗效。
评估5项ITC的相似性，以确保荟萃分析比较稳健。疗效结局包括总生存期（OS）、无进展生存期（PFS）、至下一次治疗时间（TTNT）和总缓解率（ORR）。使用稳健方差估计量处理每组间ITC均使用CARTITUDE-1数据的问题。分析覆盖CARTITUDE-1已治疗及已入组人群。
合并4项ITC评估OS。已治疗患者中，结果显著有利于cilta-cel相较于PCT（风险比HR=0.24，95%置信区间CI：0.22至0.26）。合并3项ITC评估PFS和TTNT。cilta-cel分别将疾病进展风险及接受后续治疗风险降低80%（HR=0.20，95% CI：0.06至0.70）和83%（HR=0.17，95% CI：0.12至0.26）。合并3项ITC评估ORR。已治疗患者中，cilta-cel达到总缓解的优势比是PCT的86倍。入组人群及各项敏感性分析结果一致。
多项间接比较均显示，cilta-cel疗效显著优于PCT，凸显其作为三类药物暴露RRMM患者治疗手段的有效性。
Objective: In the absence of head-to-head trials, indirect treatment comparisons (ITCs) between ciltacabtagene autoleucel (cilta-cel; in CARTITUDE-1) and treatments used in real-world clinical practice (physician's choice of treatment [PCT]), were previously conducted.
We conducted multiple meta-analyses using available ITC data to consolidate the effectiveness of cilta-cel versus PCT for patients with triple-class exposed relapsed or refractory multiple myeloma (RRMM). Methods: Five ITCs were assessed for similarity to ensure robust comparisons using meta-analysis. Effectiveness outcomes were overall survival (OS), progression-free survival (PFS), time to next treatment (TTNT), and overall response rate (ORR). A robust variance estimator was used to account for the use of CARTITUDE-1 in each pairwise ITC. Analyses were conducted in both treated and enrolled populations of CARTITUDE-1. Results: Four ITCs were combined for evaluation of OS. Results were statistically significantly in favor of cilta-cel versus PCT in treated patients (hazard ratio [HR]: 0.
24, 95% confidence interval [CI]: 0. 22-0. 26). Three ITCs were combined for evaluation of PFS and TTNT. Cilta-cel reduced the risk of progression and receiving a subsequent treatment by 80% (HR: 0. 20 [95% CI: 0. 06, 0. 70]) and 83% (HR: 0. 17 [95% CI: 0. 12, 0. 26]), respectively. Three ITCs were combined for evaluation of ORR.
Cilta-cel increased the odds of achieving an overall response by 86-times versus PCT in treated patients. Findings were consistent in the enrolled populations and across sensitivity analyses. Conclusions: Evaluating multiple indirect comparisons, cilta-cel demonstrated a significantly superior advantage over PCT, highlighting its effectiveness as a therapy in patients with triple-class exposed RRMM.
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