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接受idecabtagene vicleucel治疗的多发性骨髓瘤患者的绝对淋巴细胞计数及预后:美国骨髓瘤免疫治疗联盟的真实世界经验

Absolute Lymphocyte Count and Outcomes of Multiple Myeloma Patients Treated with Idecabtagene Vicleucel: The US Myeloma Immunotherapy Consortium Real- World Experience.

作者信息

Khouri Jack, Dima Danai, Li Hong, Hansen Doris, Sidana Surbhi, Shune Leyla, Anwer Faiz, Sborov Douglas, Wagner Charlotte, Kocoglu Mehmet H, Atrash Shebli, Voorhees Peter, Peres Lauren, Hovanky Vanna, Simmons Gary, Williams Louis, Raza Shahzad, Afrough Aimaz, Anderson Larry D, Ferreri Christopher, Hashmi Hamza, Davis James, McGuirk Joseph, Goldsmith Scott, Borogovac Azra, Lin Yi, Midha Shonali, Nadeem Omar, Locke Frederick L, Baz Rachid, Hamilton Betty, Alsina Melissa, Sauter Craig, Patel Krina, Kaur Gurbakhash

机构信息

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio.

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio.

出版信息

Transplant Cell Ther. 2024 Aug;30(8):790.e1-790.e16. doi: 10.1016/j.jtct.2024.05.025. Epub 2024 Jun 2.

Abstract

Idecabtagene vicleucel (ide-cel) has shown impressive efficacy in relapsed/refractory multiple myeloma (RRMM). This study aimed to investigate the impact of absolute lymphocyte count (ALC) on the survival outcomes of RRMM patients treated with standard of care (SOC) ide-cel. Data were collected retrospectively from 11 institutions in the U.S. Impact of ALC parameters including pre-apheresis (pre-A), pre-lymphodepletion (pre-LD), absolute and percent difference from pre-A to pre-LD on clinical outcomes after ide-cel were examined using survival analysis. A new ALC profile was created based on univariate analysis that comprises 3 groups: normal (≥1 × 10/L) pre-LD ALC (LD), low (<1 × 10/L) pre-LD ALC (LD) + percent reduction <37.5 (%R), and LD ALC + percent reduction ≥37.5 (%R). A total of 214 SOC ide-cel recipients were included in this analysis. The median patient age was 64 years (interquartile range [IQR], 57 to 69 years), median number of prior therapies was 6 (IQR, 5 to 9), and median duration of follow-up was 5.4 months (IQR, 2.1 to 8.3 months). Most patients had both low pre-A ALC (75.3%) and pre-LD ALC (77.2%), and the reduction from pre-A to pre-LD (median, .65 to .55 × 10/L) was statistically significant. Univariate analysis showed that the LD + %R group had significantly worse progression-free survival (PFS) and overall survival (OS) compared to the LD + %R and LD ALC groups (6-month PFS: 40% versus 67.6% and 60.9%; 6-month OS: 69.5% versus 87% and 94.3%). In multivariable analysis, after adjusting for age, performance status, cytogenetic risk, use of bridging therapy, and extramedullary disease, PFS did not maintain its statistical significance; however, OS remained significantly worse for LD + %R group compared to the LD ALC group (hazard ratio [HR], 4.3; 95% confidence interval [CI], 1.1 to 17), but the difference between the LD + %R versus %R groups was not statistically significant (HR, 1.7; 95% CI, .8 to 4.0). Our findings indicate that low pre-LD ALC with high %R from pre-A to pre-LD was associated with inferior survival outcomes, particularly OS, in patients who received SOC ide-cel.

摘要

伊德凯布他滨(ide-cel)在复发/难治性多发性骨髓瘤(RRMM)中显示出令人瞩目的疗效。本研究旨在调查绝对淋巴细胞计数(ALC)对接受标准治疗(SOC)伊德凯布他滨治疗的RRMM患者生存结局的影响。数据从美国11家机构进行回顾性收集。使用生存分析检查了包括单采前(pre-A)、淋巴细胞清除前(pre-LD)、从pre-A到pre-LD的绝对差值和百分比差值等ALC参数对伊德凯布他滨治疗后临床结局的影响。基于单变量分析创建了一个新的ALC概况,包括3组:正常(≥1×10⁹/L)的pre-LD ALC(LD)、低(<1×10⁹/L)的pre-LD ALC(LD)+减少百分比<37.5(%R),以及LD ALC+减少百分比≥37.5(%R)。本分析共纳入214例接受SOC伊德凯布他滨治疗的患者。患者中位年龄为64岁(四分位间距[IQR],57至69岁),既往治疗的中位次数为6次(IQR,5至9次),中位随访时间为5.4个月(IQR,2.1至8.3个月)。大多数患者pre-A ALC(75.3%)和pre-LD ALC(77.2%)均较低,从pre-A到pre-LD的减少(中位数,从0.65降至0.55×10⁹/L)具有统计学意义。单变量分析显示,与LD+%R和LD ALC组相比,LD+%R组的无进展生存期(PFS)和总生存期(OS)显著更差(6个月PFS:40%对67.6%和60.9%;6个月OS:69.5%对87%和94.3%)。在多变量分析中,在调整年龄、体能状态、细胞遗传学风险、桥接治疗的使用和髓外疾病后,PFS不再具有统计学意义;然而,与LD ALC组相比,LD+%R组的OS仍然显著更差(风险比[HR],4.3;95%置信区间[CI],1.1至17),但LD+%R组与%R组之间的差异无统计学意义(HR,1.7;95%CI,0.8至4.0)。我们的研究结果表明,接受SOC伊德凯布他滨治疗的患者中,pre-LD ALC低且从pre-A到pre-LD的%R高与较差的生存结局相关,尤其是OS。

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