CD19 targeted CAR-T therapy versus chemotherapy in re-induction treatment of refractory/relapsed acute lymphoblastic leukemia: results of a case-controlled study
CD19 targeted CAR-T therapy versus chemotherapy in re-induction treatment of refractory/relapsed acute lymphoblastic leukemia: results of a case-controlled study
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DOI：
10.1007/s00277-018-3246-4
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发表时间：
2018-05-01
影响因子：
3.5
通讯作者：
Huang, He
中科院分区：
文献类型：
--
作者：
Wei, Guoqing;Hu, Yongxian;Huang, He
抗CD 19嵌合抗原受体修饰的T细胞（CART 19）在难治性/复发性急性淋巴细胞白血病（R/R ALL）患者中具有有效的抗白血病活性。本研究旨在研究安全性/疗效与治疗方式（包括化疗和CART 19治疗）之间的相关性。CART 19组和化疗组分别入组了23例和69例患者。评价了2组中66例和22例患者的安全性和疗效特征。CART 19组的完全缓解率（CR）高于化疗组（90.9% vs 37.9%，P = 0.000）。异基因造血干细胞移植后复发者CR率为100%（8/8），化疗后复发者CR率为48.0%（12/25）（P = 0.009）;化疗后复发者CR率为85.7%（12/14），化疗后复发者CR率为31.7%（13/41）（P = 0.000）。此外，CART 19组中低于微小残留病变阈值的结果百分比较高（100 vs 7.58%，P = 0.000）。在生存分析中，CART 19组的12个月总生存率高于化疗组（60.9 vs 10.1%，P = 0.000）。CART 19组和化疗组移植后CR患者分别有25.0%（2/8）和75.0%（9/12）并发GVHD（P = 0.04）。对于所有CR患者，CART 19组中性粒细胞绝对计数低于500/mu L和血小板计数低于20，000/mu L的中位持续时间长于化疗组（分别为p = 0.0047和0.0003）。我们的数据表明，CART 19治疗的患者获得了更高的缓解率和更长的生存期，证实了CART 19治疗在R/R ALL中令人鼓舞的应用。
Chimeric antigen receptor modified T cells against CD19 (CART19s) have potent anti-leukemia activities in patients with refractory/relapsed acute lymphoblastic leukemia (R/R ALL). This study was designed to investigate the correlation between safety/efficacy and therapeutic modalities including chemotherapy and CART19 therapy. Total 23 and 69 patients were enrolled in the CART19 group and in the chemotherapy group, respectively. The safety and efficacy profiles of 66 and 22 patients in the 2 groups were evaluated. The complete remission (CR) rate was higher in the CART19 group than that in the chemotherapy group (90.9 vs 37.9%, P = 0.000). For patients relapsed after allo-HSCT and chemotherapy, CR rates were 100% (8/8) vs 48.0% (12/25) (P = 0.009) and 85.7% (12/14) vs 31.7% (13/41) (P = 0.000), respectively. Moreover, a higher percentage in the CART19 group had results below the threshold for minimal residual disease (100 vs 7.58%, P = 0.000). In survival analysis, the overall survival rate at 12 months was higher in the CART19 group than that in the chemotherapy group (60.9 vs 10.1%, P = 0.000). For post-transplant patients achieving CR, 25.0% (2/8) and 75.0% (9/12) complicated with GVHD (P = 0.04) in the CART19 group and chemotherapy group, respectively. For all CR patients, the median duration of absolute neutrophil count less than 500/mu L and platelet count less than 20,000/mu L were longer in the CART19 group than in the chemotherapy group (p = 0.0047 and 0.0003, respectively). Our data demonstrated that patients with CART19s therapy acquired higher rates of remission and longer survival, confirming the encouraging application of CART19 therapy in R/R ALL.