真实世界中利妥昔单抗生物类似药HLX-01治疗惰性B细胞淋巴瘤的有效性和安全性

Efficacy and safety of rituximab biosimilar HLX-01 in patients with indolent B-cell lymphoma in the real world

目的:探讨利妥昔单抗生物类似药HLX-01在真实世界中治疗惰性B细胞淋巴瘤(iB-NHL)的有效性和安全性。方法:回顾性分析2019年9月至2021年5月郑州大学第一附属医院肿瘤科收治的109例初治iB-NHL病例的资料,其中利妥昔单抗治疗39例(R组),HLX-01治疗70例(H组)。从一线治疗开始随访,截止日期为2021年10月31日。比较两组客观缓解率(ORR)、疾病控制率(DCR)、持续缓解时间(DOR)、治疗持续时间(DOT)、不良事件发生率。采用Kaplan-Meier法绘制生存曲线。结果:R、H组常规治疗4~6个周期后,ORR分别为84.6%、80.0%,DCR分别为97.4%、94.3%,差异无统计学意义(P>0.05)。两组DOR、DOT、总生存和无进展生存曲线差异亦无统计学意义(P>0.05)。白细胞下降、中性粒细胞减少、贫血和血小板减少是最常见的血液学毒性,转氨酶升高、呕吐、低蛋白血症、细菌感染和乏力为最常见非血液学毒性,两组不良事件发生率差异无统计学意义(P>0.05)。结论:HLX-01治疗iB-NHL与利妥昔单抗的有效性与安全性一致。

Aim:To explore the efficacy and safety of rituximab biosimilar HLX-01 for indolent B-cell lymphoma(iB-NHL)in the real world.Methods:Medical records of 109 initial treatment iB-NHL patients treated in the Department of Oncology of the First Affiliated Hospital of Zhengzhou University from September 2019 to May 2021 were retrospectively analyzed.Among them,39 cases were treated with rituximab(R group),and 70 cases were treated with HLX-01(H group).Follow-up started from first-line treatment,with a deadline of October 31,2021.The objective response rate(ORR),disease control rate(DCR),duration of response(DOR),duration of treatment(DOT)and incidence of adverse events were compared between the 2 groups.Kaplan-Meier method was used to draw survival curves.Results:After 4 to 6 cycles of treatment,ORR of R and H group was 84.6%and 80.0%,DCR was 97.4%and 94.3%respectively,and there was no statistical difference(P>0.05).There was no statistical differences in DOR,DOT,OS or PFS survival curve between the 2 groups(P>0.05).Leukopenia,neutropenia,anemia and thrombocytopenia were the most common hematologic toxicities;elevated liver enzymes,vomiting,hypoproteinemia,bacterial infection,and fatigue were the most common non-hematologic toxicities;there was no statistical differences in the incidence of adverse events between the 2 groups(P>0.05).Conclusion:The efficacy and safety of HLX-01 are consistent with those of rituximab in the treatment of iB-NHL.