肿瘤细胞治疗研究
英文原题:Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume.
Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume.
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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。
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.
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