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Axicabtagene ciloleucel 对比标准治疗用于二线大 B 细胞淋巴瘤:基于代谢肿瘤体积的结果

英文原题:Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume.

查看英文原题

Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume.

PubMed 2024/06/13(内容时间) Blood Q1 · IF 23.9(JCR 2025)

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中文摘要

代谢性肿瘤体积(MTV)通过2-脱氧-2-[18F]氟-D-葡萄糖正电子发射断层扫描评估,是衡量肿瘤负荷的一项指标,在大B细胞淋巴瘤(LBCL)中是一个有前景的预后指标。这项探索性分析评估了3期ZUMA-7研究(NCT03391466)中基线MTV(分为低[中位数或以下]与高[高于中位数])与临床结局之间的关系。在一线化学免疫治疗后12个月内复发或难治的LBCL患者按1:1随机分配至axicabtagene ciloleucel(axi-cel;自体抗CD19CAR-T 细胞疗法)或标准治疗(2-3个周期的化学免疫治疗,随后对有应答的患者进行大剂量化疗联合自体干细胞移植)。所有P值均为描述性。

在高MTV和低MTV亚组中,axi-cel相比标准治疗的无事件生存期(EFS)和无进展生存期(PFS)均更优。高MTV(相比低MTV)患者的EFS在axi-cel组中数值上更短,在标准治疗组中显著更短。在axi-cel组和标准治疗组中,高MTV患者相比低MTV患者的PFS均更短,且在数据截止时持续缓解的患者中位MTV低于其他患者。在接受axi-cel治疗并发生≥3级神经系统事件或细胞因子释放综合征(CRS)的患者中,中位MTV分别高于发生1/2级或无神经系统事件或CRS的患者。基线MTV小于或等于中位数与接受axi-cel或标准治疗作为LBCL二线治疗的患者更好的临床结局相关。该试验注册于www.ClinicalTrials.gov,编号为#NCT03391466。

展开英文摘要原文

Metabolic tumor volume (MTV) assessed using 2-deoxy-2-[18F]fluoro-d-glucose positron emission tomography, a measure of tumor burden, is a promising prognostic indicator in large B-cell lymphoma (LBCL). This exploratory analysis evaluated relationships between baseline MTV (categorized as low [median or less] vs high [greater than median]) and clinical outcomes in the phase 3 ZUMA-7 study (NCT03391466). Patients with LBCL relapsed within 12 months of or refractory to first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel (axi-cel; autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (2-3 cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem cell transplantation in patients who had a response). All P values are descriptive.

Within high- and low-MTV subgroups, event-free survival (EFS) and progression-free survival (PFS) were superior with axi-cel vs standard care. EFS in patients with high MTV (vs low MTV) was numerically shorter with axi-cel and was significantly shorter with standard care. PFS was shorter in patients with high MTV vs low MTV in both the axi-cel and standard-care arms, and median MTV was lower in patients in ongoing response at data cutoff vs others.

Median MTV was higher in patients treated with axi-cel who experienced grade ≥3 neurologic events or cytokine release syndrome (CRS) than in patients with grade 1/2 or no neurologic events or CRS, respectively. Baseline MTV less than or equal to median was associated with better clinical outcomes in patients receiving axi-cel or standard care for second-line LBCL. The trial was registered at www. clinicaltrials. gov as #NCT03391466.

论文信息

作者
Locke FL、Oluwole OO、Kuruvilla J、Thieblemont C、Morschhauser F、Salles G、Rowe SP、Vardhanabhuti S
第一作者单位
Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL.United States
通讯作者单位
Amsterdam University Medical Center (location University of Amsterdam), Cancer Center Amsterdam, Amsterdam, The Netherlands.Netherlands
文献类型
随机对照试验 · III 期临床试验 · 多中心研究 · 非美国政府资助研究
期刊
Blood2024 Jun 13
原文标识
PubMed 38557775 · DOI 10.1182/blood.2023021620