【作者】 刘丹；

【导师】 马骁；

【作者基本信息】 苏州大学 ， 血液内科， 2018， 硕士

【摘要】 【目的】分析嵌合抗原受体T细胞治疗老年恶性血液病患者的安全性和临床疗效以及临床因素对安全性和临床疗效的影响。【方法】通过回顾性研究,采集2016年03月至2017年10月在我院行嵌合抗原受体T细胞治疗23例老年恶性血液病患者的临床资料,分析CAR-T细胞输注后相关不良事件及28天内缓解率。【结果】23例患者中位年龄64(60-74)岁,男:女=14:9,结果所有接受CAR-T细胞治疗且可评估的23例患者,CAR-T细胞治疗相关不良事件发生率86.9%,>2级CRS发生率34.7%,8.7%接受托珠单抗治疗,8.7%接受激素治疗控制CRS。神经系统不良反应发生率8.7%经积极支持治疗未发生脑水肿。CAR-T细胞在体内持续扩增时间达18个月。28天内总体缓解率73.9%,通过多参数流式细胞术检测微小残留病灶阴性的缓解率为34.8%。无病生存(DFS)率至随访6个月为60%、至随访12个月为33.3%。总体生存(OS)率截至随访日期为100%;中位缓解时间未达到。【结论】初步研究的结果表明,CAR-T细胞治疗老年恶性血液病患者出现相关不良事件是短暂可控的,耐受性良好,疗效确切,该治疗方法是高龄不适合传统治疗恶性血液病患者的治疗选项。更多还原

【Abstract】 Objective: Analysis of the safety and clinical efficacy of chimeric antigen receptor T cell in the treatment of elderly patients with hematologic malignancies and the effect of clinical factors on safety and clinical efficacy.Methods: A retrospective study was conducted to collect the clinical data of 23 elderly patients with hematological malignancies treated by chimeric antigen receptor T cells from March 2016 to October 2017 in our medical center.The related adverse events and remission rate within 28 days after CAR-T cell infusion were analyzed.Results: The median age of enrolled patients was 64(range from 60 to74 years old.The ratio of male: female was 14:9.Adverse events related to CAR-T treatment occurred in elderly(86.9%)patients,while incidence of grade>2 CRS was 34.7%,8.7% patients received treatment of tocilizumab,and 8.7% patients received steroid therapy to control CRS.The incidence of adverse reactions involving nervous system was 8.7%,and no patients suffered cerebral edema after active supportive care.CAR-T cells were detected to be capable of keep expanding in vivo for 18 months.The total remission rate by which the results of laboratory testing of blood,bone marrow and cerebrospinal fluid(CSF),as well as physical examination was 73.9% at least 28 days.The remission rate tested by multiparameter flow cytometry within 28 days was 34.8%.The rate of disease-free survival(DFS)was 60% during follow-up of 6 months,and 33.3% at 12 months of follow-up.The overall survival(OS)rate was 100% at the end of the follow-up period,and the median remission duration was not reached.Conclusion: The results of our preliminary study indicate that CAR-T related adverse events in elderly patients with hematological malignancies are both transient,controllable,well tolerated and effective.CAR-T therapy is a treatment option for elderly patients who are not suitable for traditional therapy of hematological malignancies.更多还原