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axicabtagene ciloleucel 治疗大 B 细胞淋巴瘤在不同种族和族裔中的真实世界与临床试验结局

英文原题:Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity.

查看英文原题

Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity.

PubMed 2024/06/27(内容时间) Blood Q1 · IF 23.9(JCR 2025)

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中文摘要

Axicabtagene ciloleucel(axi-cel)是一种自体抗CD19嵌合抗原受体(CAR)T细胞疗法,获批用于治疗复发/难治性(R/R)大B细胞淋巴瘤(LBCL)。尽管支持其应用的数据丰富,但按种族和族裔分层的结局数据有限。本文报告真实世界和临床试验中R/R LBCL患者接受axi-cel治疗后的种族和族裔分层结局。真实世界队列来自国际血液与骨髓移植研究中心数据库,纳入2017年至2020年接受axi-cel治疗的1,290例患者;另纳入ZUMA-1和ZUMA-7试验中的106例和169例患者。各种族/族裔组总生存期相近。

然而,与非西班牙裔白人患者相比,非西班牙裔黑人患者总体缓解率较低(OR=0.37;95% CI 0.22–0.63),完全缓解率也较低(OR=0.57;95% CI 0.33–0.97)。非西班牙裔黑人患者无进展生存期也短于非西班牙裔白人(HR=1.41;95% CI 1.04–1.90)和非西班牙裔亚洲患者(HR=1.67;95% CI 1.08–2.59)。与非西班牙裔白人患者(HR=0.56;95% CI 0.33–0.94)和西班牙裔患者(HR=0.54;95% CI 0.30–0.97)相比,非西班牙裔亚洲患者缓解持续时间更长。不同种族/族裔之间细胞因子释放综合征发生率无差异;但非西班牙裔白人患者任何级别免疫效应细胞相关神经毒性综合征发生率高于其他患者。这些结果为不同种族和族裔R/R LBCL患者接受CAR-T 治疗提供了重要背景。ZUMA-1和ZUMA-7已在ClinicalTrials.gov注册,编号分别为NCT02348216和NCT03391466。

展开英文摘要原文

Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Despite extensive data supporting its use, outcomes stratified by race and ethnicity groups are limited.

Here, we report clinical outcomes with axi-cel in patients with R/R LBCL by race and ethnicity in both real-world and clinical trial settings. In the real-world setting, 1290 patients who received axi-cel between 2017 and 2020 were identified from the Center for International Blood and Marrow Transplant Research database; 106 and 169 patients were included from the ZUMA-1 and ZUMA-7 trials, respectively.

Overall survival was consistent across race/ethnicity groups.

However, non-Hispanic (NH) Black patients had lower overall response rate (OR, 0. 37; 95% CI, 0. 22-0. 63) and lower complete response rate (OR, 0. 57; 95% CI, 0. 33-0. 97) than NH White patients. NH Black patients also had a shorter progression-free survival vs NH White (HR, 1. 41; 95% CI, 1. 04-1. 90) and NH Asian patients (HR, 1. 67; 95% CI, 1. 08-2. 59). NH Asian patients had a longer duration of response than NH White (HR, 0. 56; 95% CI, 0. 33-0. 94) and Hispanic patients (HR, 0. 54; 95% CI, 0. 30-0.

97). There was no difference in cytokine release syndrome by race/ethnicity; however, higher rates of any-grade immune effector cell-associated neurotoxicity syndrome were observed in NH White patients than in other patients. These results provide important context when treating patients with R/R LBCL with CAR T-cell therapy across different racial and ethnic groups. ZUMA-1 and ZUMA-7 (ClinicalTrials. gov identifiers: #NCT02348216 and #NCT03391466, respectively) are registered on ClinicalTrials. gov.

论文信息

作者
Locke FL、Siddiqi T、Jacobson CA、Ghobadi A、Ahmed S、Miklos DB、Perales MA、Munoz J
第一作者单位
Moffitt Cancer Center, Tampa, FL.United States
通讯作者单位
Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.United States
文献类型
多中心研究 · 非美国政府资助研究 · 美国 NIH 资助研究
期刊
Blood2024 Jun 27
原文标识
PubMed 38635762 · DOI 10.1182/blood.2023023447