苯达莫司汀联合利妥昔单抗治疗初治边缘区B细胞淋巴瘤的疗效和安全性研究:一项基于倾向性评分匹配的多中心回顾性研究

Efficacy and safety of bendamustine plus rituximab in Chinese de novo margin zone lymphoma patients:A multicenter retrospective study based on propensity score matching

目的:分析苯达莫司汀联合利妥昔单抗(BR)方案在边缘区B细胞淋巴瘤(MZL)患者中的疗效和安全性。方法:回顾性分析2018年1月1日—2020年12月31日在上海和青岛的4家医院接受BR方案作为一线治疗的20例初治MZL患者的临床特点、疗效及治疗相关不良事件,应用倾向性评分匹配(PSM)将接受利妥昔单抗联合环磷酰胺、阿霉素、长春新碱和泼尼松(R-CHOP)方案治疗的20例初治MZL患者作为对照组,对比2组疗效和安全性。结果:BR组总反应率为90.0%,完全缓解率为60.0%;中位随访时间11.7(5.2~42.3)个月,1年无进展生存率和1年总生存率均为100.0%;最常见的血液学不良反应为CD4阳性淋巴细胞减少(13例)和粒细胞减少(5例),常见的非血液学不良反应为感染性发热(4例)和纳差(3例)。BR组和R-CHOP组的总反应率(90.0%vs 95.0%,P=1.000)、完全缓解率(60.0%vs 60.0%,P=1.000)比较差异均无统计学意义。R-CHOP组粒细胞减少(60.0%vs 25.0%,P=0.054)、脱发(85.0%vs 0,P<0.001)、恶心呕吐(75.0%vs 0,P<0.001)和乏力(40.0%vs 5.0%,P=0.020)不良反应的发生率显著高于BR组,其他不良反应2组间比较差异无统计学意义。结论:BR方案治疗MZL有效且安全。

Objective:To evaluate the efficacy and safety of bendamustine plus rituximab(BR)regimen in de novo margin zone lymphoma(MZL)patients.Methods:Clinical records of 20 de novo MZL patients received BR regimen in 4 hospitals in Shanghai and Qingdao from January 1 st,2018 to December 31 st,2020 were selected.Using propensity score matching(PSM)(1∶1 matching),20 de novo MZL patients treated with rituximab combined with cyclophosphamide,doxorubicin,vincristine and prednisone(R-CHOP)were collected as the control group.The clinical characters,efficacy and safety between BR group and R-CHOP group were analyzed.Results:In BR group,the overall response rate was 90.0%and the complete response rate was 60.0%.With a median follow-up of 11.7 months(5.2-42.3 months),the 1-year progression free survival rate and 1-year overall response rate were 100.0%.The commom hematological adverse events were decreased CD4;lymphocytes(13 cases)and neutropenia(5 cases).The common non-hematological adverse events were fever(4 cases)and anorexia(3 cases).Compared with R-CHOP group,there was no significant difference in overall response rate(90.0%vs 95.0%,P=1.000)and complete response rate(60.0%vs 60.0%,P=1.000).Patients in R-CHOP group suffered significantly higher rate of neutropenia(60.0%vs 25.0%,P=0.054),alopecia(85.0%vs 0,P<0.001),nausea/vomiting(75.0%vs 0,P<0.001)and fatigue(40.0%vs 5.0%,P=0.020).Conclusion:BR regimen is effective and safe for de novo MZL patients.