淋巴瘤自体造血干细胞移植中苯达莫司汀、依托泊苷、阿糖胞苷、美法仑(BeEAM)预处理方案的安全性

Safety of bendamustine,etoposide,cytarabine,melphalan(BeEAM)as preconditioning in autologous hematopoietic stem cell transplantation for patients with lymphomas

背景:近年来单克隆抗体、小分子靶向药物和免疫治疗等新药的应用显著提高了恶性淋巴瘤患者的近期疗效和长期生存,但自体造血干细胞移植在恶性淋巴瘤整体治疗中仍然具有重要的地位。在自体造血干细胞移植的整个过程中非常重要的一个环节就是预处理,但目前尚无标准的预处理方案。目的:探讨苯达莫司汀、依托泊苷、阿糖胞苷、美法仑(BeEAM)预处理方案用于淋巴瘤自体造血干细胞移植的安全性、有效性。方法:选择2021-07-05/2022-05-31于河南省人民医院血液科行BeEAM预处理方案自体造血干细胞移植的11例淋巴瘤患者纳入研究,对患者的临床特征、预处理相关非血液学毒性、造血重建进行分析。结果与结论:①BeEAM预处理方案的非血液学毒性主要为口腔黏膜炎、腹泻、粒缺期发热,发生率分别为72.7%,63.6%,90.9%;②中性粒细胞植入中位时间9(8-11)d,血小板植入中位时间10(7-16)d;③BeEAM预处理方案用于淋巴瘤自体造血干细胞移植,非血液学毒性可控,造血重建顺利,100 d移植相关死亡率为0%,截至随访期末移植相关死亡率为0%,显示出良好的疗效和安全性。中国临床试验注册中心:注册号ChiCTR2100048295。

BACKGROUND:In recent years,the application of new drugs such as monoclonal antibodies,small molecule targeted drugs and immunotherapy has significantly improved the short-term efficacy and long-term survival of patients with malignant lymphoma,but autologous hematopoietic stem cell transplantation still plays an important role in the overall treatment of malignant lymphoma.Preconditioning is a very important step in the whole process of autologous hematopoietic stem cell transplantation,but there is no standard preconditioning program at present.OBJECTIVE:To investigate the safety and effectiveness of Bendamustine,Etoposide,Cytarabine(Melphalan)BeEAM as preconditioning in autologous hematopoietic cell transplantation for patients with lymphomas.METHODS:From July 5,2021 to May 31,2022,11 patients with lymphoma who underwent autologous hematopoietic stem cell transplantation with BeEAM preconditioning regimen in Department of Hematology of Henan Provincial People’s Hospital were enrolled in the study.The clinical characteristics,pretreatingrelated non-hematologic toxicity,and hematopoietic reconstitution of the patients were analyzed.RESULTS AND CONCLUSION:(1)The non-hematological toxicity of BeEAM pretreatment regimen mainly included oral mucositis,diarrhea and fever at granulosa stage,with the incidence of 72.7%,63.6%,90.9%,respectively.(2)The median time of neutrophil implantation was 9(8-11)days,and that of platelet implantation was 10(7-16)days.(3)BeEAM pretreatment regimen for autologous hematopoietic stem cell transplantation of lymphoma has controllable nonhematologic toxicity and rapid hematopoietic reconstruction,with transplant-related mortality of 0%at 100 days and transplant-related mortality of 0%at the end of follow-up period,showing good efficacy and safety.Chinese Clinical Trial Registry:identifier No.ChiCTR2100048295.