Objective: Comparison of conventional chemotherapy and immunotargeted therapy efficacy in patients with relapsed/refractory (R/R) acute B cell leukemia (B-ALL) . Methods: The clinical data of 212 patients with R/R B-ALL in the Affiliaed Cancer Hospital of Zhengzhou University from January 2008 to July 2020 were analyzed retrospectively to compare the response rate and survival time difference between conventional chemotherapy and immunotargeted therapies (antiCD19 CAR-T and CD3CD19 bi-specific antibody blinatumomab) , and to explore the related factors affecting prognosis. Results: The CR rate of patients with R/R B-ALL treated with anti-CD19 CAR-T cells was 80.4% , patients treated with blinatumomab was 62.5% , and patients treated with chemotherapy was 38.6% . There was significant difference in the CR rate among the three therapies (P<0.001) . CAR-T cells 1-year OS rate was 41.5% , which was significantly higher than that of the chemotherapy group (10.3% ) (P<0.001) . The 1-year PFS rate of CAR-T cells (30.1% ) was also significantly higher than that of the chemotherapy group (9.7% ) (P<0.001) . The median OS of patients with bridging allo-HSCT after CR treatment by CAR-T cells was 18.5 months, which was higher than that of patients without allo-HSCT (8 months) (P=0.027) . The median PFS of patients with allo-HSCT was 17 months, which was higher than that of patients without allo-HSCT (4 months) (P=0.001) . The 1-year OS rate of patients treated with blinatumomab was 14.3% , which was higher than that of the chemotherapy group (10.3% ) (P=0.018) . The 1-year PFS rate (14.6% ) was also higher than that of the chemotherapy group (9.7% ) (P=0.046) . The median OS and median PFS of patients with bridging allo-HSCT were 13 and 11 months, respectively, which was higher than that of patients without allo-HSCT (9.5 and 6 months) . The cytokine release syndrome (CRS) incidence in patients with R/R B-ALL treated with anti-CAR-T cells was 89.8% . Grades 3-4, grade 2, and grade 1 CRS were experienced by 30.2% , 11.3% and 58.5% patients, respectively. Only three patients (37.5% ) with blinatumomab developed CRS, all of which were grade 1. Conclusion: The response rate and survival rate of patients with R/R B-ALL treated with CD19 CAR-T cells and blinatumomab were significantly better than those treated with conventional chemotherapy.
目的： 比较复发/难治（R/R）急性B淋巴细胞白血病（B-ALL）患者以常规化疗和免疫靶向治疗为挽救治疗的疗效。 方法： 回顾性分析2008年1月至2020年7月郑州大学附属肿瘤医院收治的212例R/R B-ALL患者的临床资料，分析传统化疗与针对CD19嵌合抗原受体T细胞（CAR-T细胞）和CD3CD19双特异性抗体（blinatumomab，简称双特异性抗体）的免疫靶向治疗的缓解率及生存差异，并分析其相关影响因素。 结果： CAR-T细胞治疗组的完全缓解（CR）率为80.4%（45/56），双特异性抗体治疗组的CR率为62.5%（5/8），传统化疗组的CR率为38.6%（56/145），三种方法挽救治疗的CR率差异有统计学意义（P<0.001）。CAR-T细胞治疗组患者的1年总生存（OS）率和无进展生存（PFS）率分别为41.5%和30.1%，显著高于传统化疗组的10.3%和9.7%（P值均<0.001）。双特异性抗体治疗组的1年OS率和PFS率分别为14.3%和14.6%，均高于传统化疗组（P值分别为0.018和0.046）。CAR-T细胞治疗达CR后桥接异基因造血干细胞移植（allo-HSCT）患者的中位OS及PFS时间（分别为18.5个月和17个月）较未接受allo-HSCT患者（分别为8个月和4个月）显著延长（P值均<0.05）。双特异性抗体治疗后桥接allo-HSCT患者的中位OS及PFS时间（分别为13个月和11个月）较未接受allo-HSCT患者（分别为9.5个月和6个月）延长。CAR-T细胞治疗的细胞因子释放综合征（CRS）的发生率为89.8%，其中≥3级CRS发生率为30.2%，双特异性抗体治疗组的CRS发生率为37.5%，且均为1级。 结论： CD19 CAR-T细胞及CD3CD19双特异性抗体治疗R/R B-ALL患者的缓解率及生存率均显著优于传统化疗。.
Keywords: Blinatumomab; CAR-T cell; Leukemia, B-cell, acute.