利妥昔单抗生物类似药与原研药在初治弥漫性大B细胞淋巴瘤中的疗效与安全性研究

Study on the efficacies and safeties of rituximab biosimilars and innovator drugs in the initial treatment of diffuse large B-cell lymphoma

目的:比较利妥昔单抗生物类似药(汉利康^(®))和原研药(美罗华^(®))联合CHOP方案治疗初治弥漫性大B细胞淋巴瘤(diffuse large B-cell lymphoma,DLBCL)的临床效果和安全性。方法:回顾性分析2018年1月—2021年3月南通市肿瘤医院收治的采用R-CHOP方案免疫化疗的91例初治DLBCL的临床病理资料。根据所用利妥昔单抗品牌的不同分为美罗华治疗组(R-CHOP组)(n=50)和汉利康治疗组(H-CHOP组)(n=41)。观察两组患者的客观缓解率(objective response rate,ORR)、无进展生存期(progression free survival,PFS)、总生存期(overall survival,OS)和治疗相关不良事件(treatment emergent adverse event,TEAE)。结果:中位随访40个月,R-CHOP组和H-CHOP组的ORR为74.0%vs 87.8%(P=0.100),两组患者中位PFS和OS均未达到(P=0.302和P=0.284)。安全性方面,R-CHOP组和H-CHOP组最常见的TEAE均为白细胞减少和中性粒细胞减少,两组整体TEAE发生率相当(P=0.887)。结论:国产利妥昔单抗生物类似药(汉利康^(®))与原研药(美罗华^(®))在初治DLBCL中疗效和安全性相当,患者耐受性良好。

Objective:To compare the clinical efficacies and safeties of rituximab biosimilars(HLX01^(®))and innovator drugs(Mabthera^(®))combined with CHOP regimen in the initial treatment of diffuse large B-cell lymphoma(DLBCL).Methods:The clinicopathological data of 91 DLBCL patients initially treated with R-CHOP regimen in Nantong Tumor Hospital from January 2018 to March 2021 were retrospectively analyzed.According to the different brands of rituximab used,they were divided into Mabthera treatment group(R-CHOP group)(n=50)and HLX01 treatment group(H-CHOP group)(n=41).The objective response rate(ORR),progression free survival(PFS),overall survival(OS)and treatment emergent adverse event(TEAE)in the two groups were observed.Results:The median follow-up time was 40 months.The ORR was 74.0%in the R-CHOP group and 87.8%in the H-CHOP group(P=0.100).The median PFS and OS were not reached in the two groups(P=0.302 and P=0.284).In terms of safety,the most common TEAEs in both R-CHOP group and H-CHOP group were decreased white blood cell count and neutrophil count,and the overall incidence of TEAEs was similar between the two groups(P=0.887).Conclusion:The efficacy and safety are comparable between domestic rituximab biosimilars(HLX01^(®))and the innovator drugs(Mabthera^(®))in the initial treatment of DLBCL,and both drugs are well tolerated in the patients.