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作 者:朱倩[1,2] 王倩 康丽清[3] 金正明 李彩霞 吴德沛[1,2] 俞磊 黄海雯[1,2] ZHU Qian;WANG Qian;KANG Li-qing;JIN Zheng-ming;LI Cai-xia;WU De-pei;YU Lei;HUANGHai-wen(Department of Hematology,First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,215006,China;National Clinical Research Center for Hematologic Diseases,Suzhou,Jiangsu,215006,China;UniCar Therapy Ltd.,Shanghai,201203,China)
机构地区:[1]苏州大学附属第一医院血液科,江苏苏州215006 [2]国家血液病临床研究中心,江苏苏州215006 [3]上海优卡迪生物医药科技有限公司,上海201203
出 处:《中国血液流变学杂志》2023年第4期507-515,565,共10页Chinese Journal of Hemorheology
基 金:国家血液病临床医学研究中心转换研究开发课题基金(2020ZKMB02)。
摘 要:目的探索CAR-T细胞疗法后桥接HSCT是否能进一步改善复发难治性淋巴瘤患者的生存。方法85例R/R淋巴瘤接受CAR-T治疗的患者,其中51例在CAR-T后获得CR或PR,12/51例患者接受CAR-T后的HSCT治疗。通过倾向评分匹配(PSM)对其余39/51例患者中的24例患者进行匹配,作为对照组。比较CAR-T和CAR-T桥接HSCT治疗R/R淋巴瘤的疗效和安全性。结果共纳入36例患者,CAR-T后桥接移植组12例,CAR-T后随访组24例。两组患者在临床、治疗以及不良反应等基线资料差异无统计学意义,CAR-T治疗缓解后桥接HSCT的患者较CAR-T治疗后随访组并没有展现出生存优势,1年OS分别为83.3%和82.9%(P=0.702),1年PFS分别为83.3%和66.7%(P=0.489)。两组患者1年CIR分别为8.3%和30.0%(P=0.417)。CAR-T桥接HSCT组1年TRM为8.3%。结论CAR-T治疗后获得CR以及PR的复发难治性淋巴瘤患者,在缓解状态下桥接HSCT作为巩固治疗,并未体现出明显的生存优势。而先前接受过CAR-T治疗的患者在后续HSCT过程中发生的毒性反应也并没有高于预期。Objective To explore whether consolidative HSCT confers superior survival outcomes to patients with refractory/relapsed lymphoma who got remission by CAR-T cells therapy.Methods 85 patients with refractory/relapsed lymphoma received CAR-T therapy,51 of them obtained CR or PR disease status after CAR-T,12/51 were treated with HSCT following CAR-T.24 patients were matched among the remaining 39/51 patients by propensity score matching(PSM)as a control group.Compare the efficacy and safety of HSCT following CAR-T and CAR-T regimen in patients with refractory/relapsed lymphoma.Results A total of 36 patients were enrolled.12 patients were treated with HSCT after CAR-T,and 24 patients treated with CAR-T only.Between the post-CAR-T HSCT group and CAR-T group,the corresponding 1-year PFS rate was 83.3%and 66.7%(P=0.489),respectively.And 1-year OS rate were 83.3%and 82.9%(P=0.702),respectively.The 1-year CIR of the two groups were 8.3%and 30.0%respectively(P=0.417).The 1-year TRM in post-CAR-T HSCT group was 8.3%.Conclusion HSCT appears no improvement of PFS and OS for the patients achieving remission following CAR-T therapy with refractory/relapsed lymphoma.Patients treated with prior CAR-T did not experience toxicity higher than expected during subsequent HSCT.Future prospective and randomized clinical studies are needed to clearly define the role of consolidative HSCT in the refractory/relapsed lymphoma patients.
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