Efficacy and safety of bendamustine plus rituximab in Chinese de novo margin zone lymphoma patients: A multicenter retrospective study based on propensity score matching
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摘要: 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。Abstract: 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 1st, 2018 to December 31st, 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.
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Key words:
- bendamustine /
- rituximab /
- margin zone lymphoma /
- efficacy /
- safety /
- propensity score matching
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表 1 BR组和R-CHOP组临床基线特征
例(%) 临床特征 PSM前 PSM后 BR组(20例) R-CHOP组
(94例)P BR组(20例) R-CHOP组
(20例)P 男性 10(50.0) 55(58.5) 0.485 10(50.0) 11(55.0) 0.752 年龄≥70岁 5(25.0) 12(12.8) 0.175 5(25.0) 3(15.0) 0.695 病理亚型 0.406 0.493 MALT 18(90.0) 77(81.9) 18(90.0) 19(95.0) NZML 1(5.0) 14(14.9) 1(5.0) 1(5.0) SMZL 1(5.0) 3(3.2) 1(5.0) 0 Ann Arbor Ⅲ/Ⅳ期 13(65.0) 66(70.2) 0.646 13(65.0) 11(55.0) 0.519 ECOG≥2 9(45.0) 30(31.9) 0.263 9(45.0) 7(35.0) 0.519 B症状 12(60.0) 31(33.0) 0.024 12(60.0) 10(50.0) 0.525 MALT-IPI 0.025 0.233 低危 12(60.0) 73(77.7) 12(60.0) 15(75.0) 中危 6(30.0) 21(22.3) 6(30.0) 5(25.0) 高危 2(10.0) 0 2(10.0) 0 ki67 0.937 0.179 ≤15% 13(65.0) 60(63.8) 13(65.0) 17(85.0) 15%<ki67≤30% 5(25.0) 22(23.4) 5(25.0) 1(5.0) >30% 2(10.0) 12(12.8) 2(10.0) 2(10.0) 血红蛋白 < 120 g/L 7(35.0) 14(14.9) 0.035 7(35.0) 5(25.0) 0.490 血小板减少 2(10.0) 5(5.3) 0.604 2(10.0) 1(5.0) 1.000 LDH升高 5(25.0) 14(14.9) 0.321 5(25.0) 4(20.0) 1.000 β2-MG升高 12(60.0) 36(38.3) 0.074 12(60.0) 8(40.0) 0.206 D-二聚体升高 3(15.0) 23(24.5) 0.558 3(15.0) 5(25.0) 0.695 骨髓累及 6(30.0) 19(20.2) 0.376 6(30.0) 4(20.0) 0.465 淋巴结受累个数≥6 4(20.0) 27(28.7) 0.426 4(20.0) 2(10.0) 0.661 结外受累器官≥2 4(20.0) 17(18.1) 0.761 4(20.0) 3(15.0) 1.000 
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表 2 BR组和R-CHOP组疗效和预后
疗效 BR组
(20例)R-CHOP组
(20例)P ORR/例(%) 18(90.0) 19(95.0) 1.000 CR/例(%) 12(60.0) 12(60.0) 1.000 1年PFS/% 100.0 88.9 0.487 1年OS/% 100.0 100.0 1.000 1.5年PFS/% 100.0 81.5 0.106 1.5年OS/% 100.0 85.1 0.231
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