Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma
Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma
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DOI：
10.1056/nejmoa2116133
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发表时间：
2021-12-11
影响因子：
158.5
通讯作者：
Westin, J. R.
中科院分区：
文献类型：
--
作者：
Locke, F. L.;Miklos, D. B.;Westin, J. R.
背景接受一线化疗免疫治疗后早期复发或难治性大B细胞淋巴瘤患者的预后较差。1比率，接受axicabtagene ciloleucel一线化疗后12个月内复发或难治的大B细胞淋巴瘤患者（axi-cel，一种自体抗CD 19嵌合抗原受体T细胞疗法）或标准治疗（两个或三个周期的化疗选择，方案定义的化学免疫治疗，然后在对化学免疫治疗有反应的患者中进行高剂量化疗和自体干细胞移植）。主要终点是盲法中心审查的无事件生存期。关键的次要终点是反应和总生存期。安全性也进行了评估。共有180名患者被随机分配接受axi-cel治疗，179名患者接受标准治疗。无事件生存期的主要终点分析显示，axi-cel治疗上级标准治疗。在中位随访24.9个月时，Axi-cel组的中位无事件生存期为8.3个月，标准治疗组为2.0个月，24个月无事件生存期分别为41%和16%（事件或死亡的风险比为0.40; 95%置信区间为0.31至0.51; P
BACKGROUNDThe prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor.METHODSIn this international, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy). The primary end point was event-free survival according to blinded central review. Key secondary end points were response and overall survival. Safety was also assessed.RESULTSA total of 180 patients were randomly assigned to receive axi-cel and 179 to receive standard care. The primary end-point analysis of event-free survival showed that axi-cel therapy was superior to standard care. At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P