| 引用本文： |
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董林,王耀辉,叶世光,等.伊布替尼联合CD19嵌合抗原受体T细胞治疗难治复发弥漫大B细胞淋巴瘤的临床研究[J].同济大学学报（医学版）,2021,42(2):199-205. [点击复制]
- DONG Lin,WANG Yao-hui,YE Shi-guang,et al.Efficacy of Ibrutinib combined with CD19 chimeric antigen receptor T cells（CAR-T) in treatment of recurrent refractory[J].同济大学学报（医学版）,2021,42(2):199-205. [点击复制]
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| 摘要: |
| 目的评估伊布替尼联合CD19 CAR-T细胞方案与CD19 CAR-T细胞方案治疗复发难治弥漫大B细胞淋巴瘤(diffuse large B cell lymphoma, DLBCL)患者的疗效和安全性。方法回顾性分析2018年1月—2019年1月在同济大学附属同济医院血液科 26例接受CD19 CAR-T细胞治疗的DLBCL患者。根据患者既往是否口服伊布替尼治疗，分为对照组和伊布替尼组，对照组10例，伊布替尼组16例。统计患者治疗期间血常规、血生化、电解质、细胞因子、肝肾功能，疗效评估，不良反应事件，比较两组的完全缓解率、总有效率、总生存时间，细胞因子表达水平变化及不良反应情况。采用t检验、Fisher确切概率法比较两组患者临床特征差异；采用Kaplan-Meier 分析两组患者生存率。结果伊布替尼组患者总体缓解率高于对照组患者，差异有统计学意义（P<0.05）;完全缓解率高于对照组患者，但无统计学意义（P>0.05）。两组患者总体生存率（overall survival，OS）和无进展生存率（progression-free survival， PFS）差异无统计学意义（P>0.05）。伊布替尼组患者与对照组患者细胞因子释放综合征(cytokine release syndrome， CRS)发生率差异无统计学意义（P>0.05）。两组患者神经系统、肝肾功能等不良反应事件发生率差异无统计学意义（P>0.05）。伊布替尼组患者输注CD19 CAR-T细胞后，血清中IL-6、IL-8、TNF-α和CRP水平均高于对照组，但差异均无统计学意义（P>0.05）。结论伊布替尼联合CD19 CAR-T治疗难治复发DLBCL与单用CD19 CAR-T相比，能显著提高总有效率，同时不增加CART治疗的毒副反应。 |
| 关键词: 难治复发弥漫大B细胞淋巴瘤 CD19嵌合抗原受体T细胞 伊布替尼 |
| DOI：10.12289/j.issn.1008-0392.20278 |
| 投稿时间：2020-06-20 |
| 基金项目: |
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| Efficacy of Ibrutinib combined with CD19 chimeric antigen receptor T cells（CAR-T) in treatment of recurrent refractory |
| DONG Lin,WANG Yao-hui,YE Shi-guang,ZHOU Li-li,LI Ping,LIANG Ai-bin |
| (School of Medicine, Tongji University, Shanghai 200092, China; Dept. of Hematology, Tongji Hospital, School of Medicine, Tongji University, Shanghai 200065, China) |
| Abstract: |
| ObjectiveTo evaluate the efficacy and safety of Ibrutinib combined with CD19 chimeric antigen receptor T cells（CAR-T) protocol in treatment of patients with recurrent refractory diffuse large B cell lymphoma. MethodsThe clinical data of 26 refractory recurrence DLBCL patients who received CAR-T treatment in Hematology Department of Tongji Hospital Tongji University from January 2018 to January 2019 were reviewed, including 10 cases treated with CAR-T alone（control group) and 16 cases treated with CAR-T plus Ibrutinib（study group). Blood routine, blood biochemistry, electrolyte, cytokine, liver and kidney function, efficacy evaluation, adverse reaction events were compared between the two groups. Clinical characteristics were compared by using t test and fisher exact probability method. Kaplan-Meier survival analysis was adopted to analyze the overall survival（OS) and progression-free survival（PFS) of patients. ResultsThe overall remission rate of study group was higher than that of control group（P<0.05). There was a trend of higher complete remission rate in study group, but with no significant difference compared with control group（P>0.05).There were no significant differences in OS and PFS between the two groups（P>0.05). No statistically significant differences in the incidence of cytokine release syndrome（CRS) and adverse reaction like nervous system reactions and liver and kidney function were found between the two groups（P>0.05). The serum levels of IL-6, IL-8, TNF-α and CRP in study group tended higher, but there was no significant difference with control group（P>0.05). ConclusionIbrutinib combined with CD19 CAR-T treatment for refractory recurrent diffuse large B cell lymphoma significantly improves overall effective rate without increasing toxic side effects compared with CD19 CAR-T used alone. |
| Key words: diffuse large B cell lymphoma chimeric antigen receptor T cells recognizing CD19 Ibrutinib |
