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标准治疗 Idecabtagene Vicleucel 与 Ciltacabtagene Autoleucel 在复发/难治性多发性骨髓瘤中的比较

英文原题:Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma.

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Comparison of Standard-of-Care Idecabtagene Vicleucel and Ciltacabtagene Autoleucel in Relapsed/Refractory Multiple Myeloma.

PubMed 2025/02/18(内容时间) J Clin Oncol Q1 · IF 44.7(JCR 2025)

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研究概要

与 ide-cel 相比,cilta-cel 显示出更优的疗效和生存获益,但某些毒性的发生率更高。

研究思路结论见上方概要

Idecabtagene vicleucel(ide-cel)和ciltacabtagene autoleucel(cilta-cel)是两种靶向B细胞成熟抗原的嵌合抗原受体(CAR)T细胞疗法,在复发/难治性多发性骨髓瘤(RRMM)中已显示出显著疗效。我们比较了接受标准治疗(SOC)ide-cel或cilta-cel治疗的RRMM患者的安全性、疗效和生存期。

数据来自一项回顾性病历审查,纳入截至2022年12月31日已进行白细胞采集、计划在19家机构接受SOC ide-cel或cilta-cel治疗的RRMM患者。采用逆概率治疗加权(IPTW)方法按治疗类型比较结局。

截至2022年12月31日,共有641例患者接受了白细胞采集,其中ide-cel组(n = 386)和cilta-cel组(n = 255)。共有586例患者接受了输注(ide-cel组 n = 350;cilta-cel组 n = 236),ide-cel和cilta-cel的中位随访时间分别为12.6个月和13.0个月。经过IPTW后,患者特征均衡良好。Cilta-cel与更高的3级细胞因子释放综合征(CRS;比值比[OR],6.80 [95% CI,2.28至20.33])、感染(OR,2.03 [95% CI,1.41至2.92])、第二原发恶性肿瘤(OR,1.77 [95% CI,0.89至3.56])和迟发性神经毒性(OR,20.07 [95% CI,4.46至90.20])发生可能性相关。Cilta-cel还与更好的治疗反应(完全缓解:OR,2.42 [95% CI,1.63至3.60])、更长的无进展生存期(风险比[HR],0.48 [95% CI,0.36至0.63])和更长的总生存期(HR,0.67 [95% CI,0.46至0.97])相关。未观察到治疗类型与免疫效应细胞相关神经毒性综合征、任何CRS、第30天和第90天严重血细胞减少或非复发死亡率之间的关联。当重复分析,将ide-cel队列限制为与cilta-cel获美国食品药品监督管理局批准(2022年3月)同一时间段内输注的患者时,我们观察到了一致的结果。

展开英文摘要原文

Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapies have demonstrated remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). We compare safety, efficacy, and survival among patients with RRMM treated with standard-of-care (SOC) ide-cel or cilta-cel.

Data were from a retrospective chart review of patients with RRMM leukapheresed by December 31, 2022, with the intent to receive SOC ide-cel or cilta-cel at 19 institutions. An inverse probability of treatment weighting (IPTW) approach was used to compare outcomes by therapy type.

A total of 641 patients were leukapheresed by December 31, 2022, with ide-cel (n = 386) and cilta-cel (n = 255). Five hundred eighty-six patients were infused (n = 350 for ide-cel; n = 236 for cilta-cel) with a median follow-up of 12.6 and 13.0 months for ide-cel and cilta-cel, respectively. After IPTW, patient characteristics were well balanced. Cilta-cel was associated with higher likelihood of grade 3 cytokine release syndrome (CRS; odds ratio [OR], 6.80 [95% CI, 2.28 to 20.33]), infections (OR, 2.03 [95% CI, 1.41 to 2.92]), second primary malignancies (OR, 1.77 [95% CI, 0.89 to 3.56]), and delayed neurotoxicity (OR, 20.07 [95% CI, 4.46 to 90.20]). Cilta-cel was also associated with better treatment responses ( complete response: OR, 2.42 [95% CI, 1.63 to 3.60]), longer progression-free survival (hazard ratio [HR], 0.48 [95% CI, 0.36 to 0.63]), and longer overall survival (HR, 0.67 [95% CI, 0.46 to 0.97]). No associations were observed between therapy type and immune effector cell-associated neurotoxicity syndrome, any CRS, severe cytopenia at days 30 and 90, or nonrelapse mortality. We observed consistent findings when repeating the analyses restricting the ide-cel cohort to patients infused during the same time period as Food and Drug Administration approval for cilta-cel ( March 2022).

Cilta-cel demonstrated superior efficacy and survival, with higher incidence of certain toxicities, compared with ide-cel.

论文信息

作者
Hansen DK、Peres LC、Dima D、Richards A、Shune L、Afrough A、Midha S、Dhakal B
第一作者单位
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.United States
通讯作者单位
Stanford University School of Medicine, Stanford, CA.
文献类型
对照研究 · 多中心研究 · 美国 NIH 资助研究
期刊
Journal of clinical oncology : official journal of the American Society of Clinical Oncology2025 May
原文标识
PubMed 39965175 · DOI 10.1200/JCO-24-01730