西达本胺维持治疗预防外周T细胞淋巴瘤自体造血干细胞移植术后复发的临床观察

Maintenance therapy with chidamide prevents from postoperative recurrence after autologous hematopoietic stem cell transplantation for peripheral T cell lymphoma

目的探讨西达本胺维持治疗预防外周T细胞淋巴瘤患者自体外周血干细胞移植术后复发的效果和安全性。方法回顾性分析本中心2017年1月至2018年5月接受自体造血干细胞移植术后的外周T细胞淋巴瘤患者49例,根据移植后是否采用西达本胺维持治疗分为试验组(23例)和对照组(26例)。试验组在移植后30~45 d予西达本胺维持治疗(口服30 mg/次,2次/周,间隔不少于3 d,早餐30 min后服用);对照组移植结束后不采用药物治疗,仅定期观察随访。主要观察指标为移植后2年复发率,次要观察指标包括1年复发率,1年、2年无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS);西达本胺维持治疗期间的药物不良反应。结果两组患者随访至2020年5月,试验组移植后2年复发率为39.1%,显著低于对照组的69.2%(P=0.047)。移植后1年,试验组复发5例(21.7%),对照组复发14例(53.8%),对照组复发率显著高于试验组(P=0.039)。移植后1年,试验组PFS明显优于对照组,两组间OS无明显差异;移植后2年,试验组PFS及OS均明显优于对照组。西达本胺维持治疗的复发率与患者年龄、性别、病理类型、临床分期、骨髓浸润、IPI评分无相关性(P>0.05),而移植前疾病未达完全缓解及乳酸脱氢酶升高为预后不良的危险因素(P<0.05)。西达本胺维持治疗的不良反应主要表现为血液学毒性10例,乏力5例,消化道不良反应4例;肝肾功能轻度损害、血栓事件各1例,无1例发生心脏毒副作用。结论西达本胺维持治疗可降低外周T细胞淋巴瘤自体造血干细胞移植术后复发;且安全性较高。

Objective To investigate the efficacy and safety of chidamide maintenance therapy in prevention of the recurrence of peripheral T-cell lymphoma after autologous peripheral blood stem cell transplantation(auto-PBSCT).Methods A retrospective study was carried out on 49 patients with peripheral T-cell lymphoma undergoing auto-PBSCT in our medical center from January 2017 to May 2018.According to whether receiving chidamide maintenance treatment after transplantation or not,they were divided into experimental group(n=23)and control group(n=26).The patients from the former group were given chidamide maintenance treatment,by taking orally 30 mg/time,twice/week,in an interval not less than 3 d,30 min after breakfast,initiating from 30 to 45 d after transplantation.While those of the control group got no maintenance treatment,but were only examined and followed up regularly after transplantation.The main outcome measure was to observe the recurrence rate between these 2 groups in 2 years after transplantation.The secondary indicator was the differences in 1-year recurrence rate,1-and 2-year progression free survival(PFS),and 2-year overall survival(OS)between them.The adverse effects of chidamide were observed during the maintenance treatment.Results Until the last follow-up of May 2020,the 2-year recurrence rate was only 39.1%in the experimental group,which was significantly lower than that of the control group(69.2%,P=0.047).In 1 year after transplantation,5 patients(21.7%)in the experimental group and 14 patients(53.8%)in the control group had recurrence,with that in the control group significantly higher than that in the experimental group(P=0.039).The 1-year PFS was significantly better in the experimental group than the control group,but there was no significant difference in the 1-year OS between them.The experimental group also obtained better 2-year PSF and OS rates than the control group.No correlations were observed in the recurrence rate of citabenamine maintenance therapy with age,gender,pathological type,clinical stage,bone marrow invasion,and International Prognostic Index(IPI)score respectively(P>0.05).However,incomplete remission and elevated LDH level before transplantation were risk factors for poor prognosis(P<0.05).The main adverse reactions of chidamide maintenance therapy were hematological adverse reactions in 10 cases,fatigue in 5 cases,digestive tract adverse reactions in 4 cases,and both mild damage to liver and kidney functions and thrombosis in 1 case.No adverse cardiac effect was found in 1 case.Conclusion Chidamide maintenance therapy reduces the recurrence of peripheral T cell lymphoma after auto-PBSCT,with good safety.