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创新型利妥昔单抗及其生物类似药在弥漫性大B细胞淋巴瘤患者中的疗效比较:一项回顾性分析

Comparison of the Efficacy of Innovator Rituximab and its Biosimilars in Diffuse Large B Cell Lymphoma Patients: A Retrospective Analysis.

作者信息

Bankar Aniket, Korula Anu, Abraham Aby, Viswabandya Auro, George Biju, Srivastava Alok, Mathews Vikram

机构信息

Department of Haematology, Christian Medical College, Vellore, India.

出版信息

Indian J Hematol Blood Transfus. 2020 Jan;36(1):71-77. doi: 10.1007/s12288-019-01167-w. Epub 2019 Aug 6.

DOI:10.1007/s12288-019-01167-w
PMID:32174693
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7042466/
Abstract

Diffuse large B cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma among adults, although it also affects the young and the elderly. DLBCL is treated with a chimeric monoclonal antibody against CD20, a B cell surface protein, named rituximab, in combination with a multidrug chemotherapeutic regimen. However, owing to its high cost, rituximab cannot be afforded by patients in developing or underdeveloped countries. In such cases, biosimilars of rituximab have been used instead of rituximab, with equivalent efficacy. In this single center, retrospective, observational study, we have compared patient outcomes such complete response (CR), partial response (PR), and overall response rate (ORR) in a cohort of 152 patients in an Indian hospital, who were treated either with innovator rituximab or Reditux, a biosimilar. We observed that the ORRs of both groups (88% in innnovator group and 82% in biosimilar group) were comparable. There was no statistically significant difference between the two groups in terms of CR ( = 0.353), PR ( = 0.42), ORR ( = 0.23), unfavorable responses, and stable or progressive disease ( = 0.42). The number of patients who died due to complications were few, and there was no significant difference between the two groups. The differences in the 3-year event-free survival and overall survival were not statistically significant. Biosimilar rituximab can suitably and safely replace the innovator rituximab for treatment of diffuse large B cell lymphoma.

摘要

弥漫性大B细胞淋巴瘤(DLBCL)是成人非霍奇金淋巴瘤最常见的形式,不过它也会影响年轻人和老年人。DLBCL的治疗采用一种针对B细胞表面蛋白CD20的嵌合单克隆抗体,名为利妥昔单抗,并联合多药化疗方案。然而,由于成本高昂,发展中国家或不发达国家的患者无法负担利妥昔单抗。在这种情况下,利妥昔单抗的生物类似药已被用于替代利妥昔单抗,且疗效相当。在这项单中心、回顾性、观察性研究中,我们比较了印度一家医院152例患者的治疗结果,这些患者分别接受了原研利妥昔单抗或生物类似药雷迪妥昔单抗的治疗,比较指标包括完全缓解(CR)、部分缓解(PR)和总缓解率(ORR)。我们观察到两组的ORR(原研药组为88%,生物类似药组为82%)具有可比性。两组在CR(=0.353)、PR(=0.42)、ORR(=0.23)、不良反应以及病情稳定或进展(=0.42)方面无统计学显著差异。因并发症死亡的患者数量很少,两组之间也无显著差异。3年无事件生存率和总生存率的差异无统计学意义。生物类似药利妥昔单抗可合适且安全地替代原研利妥昔单抗用于治疗弥漫性大B细胞淋巴瘤。

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