CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Absolute Lymphocyte Count and Outcomes of Multiple Myeloma Patients Treated with Idecabtagene Vicleucel: The US Myeloma Immunotherapy Consortium Real- World Experience.
Absolute Lymphocyte Count and Outcomes of Multiple Myeloma Patients Treated with Idecabtagene Vicleucel: The US Myeloma Immunotherapy Consortium Real- World Experience.
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Idecabtagene vicleucel（ide-cel）在复发/难治性多发性骨髓瘤（RRMM）中显示出令人印象深刻的疗效。
本研究旨在探讨绝对淋巴细胞计数（ALC）对接受标准治疗（SOC）ide-cel的RRMM患者生存结局的影响。数据从美国11家机构回顾性收集。采用生存分析检验ALC参数（包括单采前（pre-A）、淋巴细胞清除前（pre-LD）、从pre-A到pre-LD的绝对差值及百分比差值）对ide-cel治疗后临床结局的影响。基于单因素分析创建了一个新的ALC特征谱，包括3组：pre-LD ALC正常（≥1 × 10 9 /L）（LD N）、pre-LD ALC低（<1 × 10 9 /L）（LD L）+百分比下降<37.5（%R L），以及LD L ALC+百分比下降≥37.5（%R H）。本分析共纳入214例接受SOC ide-cel的患者。患者中位年龄为64岁（四分位距[IQR]，57至69岁），中位既往治疗线数为6（IQR，5至9），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，且从pre-A到pre-LD的下降（中位数，.65至.55 × 10 9 /L）具有统计学意义。单因素分析显示，与LD L + %R L 组和LD N ALC组相比，LD L + %R H 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，调整年龄、体能状态、细胞遗传学风险、桥接治疗使用及髓外疾病后，PFS未保持其统计学显著性；然而，与LD N ALC组相比，LD L + %R H组的OS仍显著更差（风险比[HR]，4.3；95%置信区间[CI]，1.1至17），但LD L + %R H组与%R L组之间的差异无统计学意义（HR，1.7；95% CI，.8至4.0）。
我们的研究结果表明，在接受SOC ide-cel的患者中，pre-LD时低ALC且从pre-A至pre-LD高%R与较差的生存结局相关，尤其是OS。
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 9 /L) pre-LD ALC (LD N ), low (<1 × 10 9 /L) pre-LD ALC (LD L ) + percent reduction <37. 5 (%R L ), and LD L ALC + percent reduction ≥37. 5 (%R H ). 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 9 /L) was statistically significant. Univariate analysis showed that the LD L + %R H group had significantly worse progression-free survival (PFS) and overall survival (OS) compared to the LD L + %R L and LD N 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 L + %R H group compared to the LD N ALC group (hazard ratio [HR], 4. 3; 95% confidence interval [CI], 1. 1 to 17), but the difference between the LD L + %R H versus %R L 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.
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