伊布替尼单药治疗复发及难治套细胞淋巴瘤的临床疗效及安全性

Efficacy and safety of ibrutinib monotherapy in the treatment of relapsed/refractory mantle cell lymphoma

目的:套细胞淋巴瘤是一种少见类型的目前仍不可治愈的非霍奇金淋巴瘤,初始治疗缓解率高,但易复发,总体预后差。国外多项研究显示伊布替尼在套细胞淋巴瘤中有效率较高,但该药在中国上市时间短,目前缺乏相应临床研究结果。本文通过分析伊布替尼单药在复发/难治套细胞淋巴瘤治疗中的疗效及安全性,为临床治疗提供参考依据。方法:对接受伊布替尼单药治疗的30例复发/难治套细胞淋巴瘤患者的临床资料进行回顾性分析,主要研究指标为客观缓解率、疾病控制率、3年无进展生存率及总生存率以及治疗相关不良反应。结果:本组患者客观缓解率为46.7%,疾病控制率为80.0%,3年无进展生存率及总生存率分别为85.8%和94.8%。30例患者共发生56例次不良反应,血液学不良反应中最常见的为血小板减少(46.7%),非血液学不良反应中感染(16.7%)、出血(13.3%)和皮疹(13.3%)等较为常见,在实施对症干预后均可缓解。结论:伊布替尼单药对于复发/难治套细胞淋巴瘤是一种疗效、可行性及耐受性均较好的治疗方案。

Objective:Mantle cell lymphoma(MCL) is a rare type of nonHodgkin's lymphoma(NHL) that is still incurable.The initial treatment response rate is high,but it is prone to relapse and the overall prognosis is poor.Many foreign studies have shown that ibrutinib is effective in mantle cell lymphoma,but the drug has been on the market for a short time in China,and there is a lack of corresponding clinical research results.The purpose of this study is to analyze the efficacy and safety of ibrutinib monotherapy in the treatment of relapsed/refractory mantle cell lymphoma(R/R-MCL) in order to provide a reference for clinical treatment.Methods:The clinical data of 30 patients with R/R-MCL treated with ibrutinib monotherapy in our hospital were analyzed retrospectively.The objective remission rate(ORR),disease control rate(DCR),3-year progression-free survival(PFS),overall survival time(OS) and treatment-related adverse reactions were studied.Results:The ORR of the patients in this group was 46.7%,the DCR was 80.0%,the 3-year PFS and OS were 85.8% and 94.8%,respectively.A total of 56 adverse reactions occurred in 30 patients.The most common hematological adverse reaction was thrombocytopenia(46.7%).Non-hematological adverse reactions such as infection(16.7%)、bleeding(13.3%) and rash(13.3%) were more common,which could be alleviated after symptomatic intervention.Conclusion:Ibrutinib monotherapy is an effective,feasible and tolerable treatment for R/R-MCL.