Zytux™与美罗华®联合FCR方案治疗慢性淋巴细胞白血病的双盲、随机对照研究：非劣效性临床试验
A Double-Blind, Randomized Comparison Study between Zytux™ vs MabThera® in Treatment of CLL with FCR Regimen: Non-Inferiority Clinical Trial.
作者信息
Toogeh Gholamreza, Faranoush Mohammad, Razavi Seyed Mohsen, Jalaeikhoo Hassan, Allahyari Abolghasem, Ravanbod Mohammad Reza, Zarrabi Fariba, Fallahazad Vahid, Rezaei Darzi Ehsan, Alizadeh Fard Shadi Sadat
机构信息
Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Department of Internal Medicine, Hematology and Medical Oncology Ward, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Int J Hematol Oncol Stem Cell Res. 2018 Apr 1;12(2):84-91.
BACKGROUND
Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera in treatment of CLL.
MATERIALS AND METHODS
Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux™, and group B was treated with MabThera. A non-inferiority margin of 20% for the primary outcome was defined to examine the similarity between Zytux™ and MabThera.
RESULTS
Baseline demographic characteristics showed no statistically significant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux™ demonstrated a similar profile of adverse reactions in comparison to MabThera. Moreover, the overall response rate was 88% and 89% for Zytux™ and MabThera, respectively (CI -0.17, 0.18).
CONCLUSION
Results showed non-inferiority of Zytux™ in terms of efficacy and adverse events as a biosimilar version of MabThera.
背景
慢性淋巴细胞白血病（CLL）的特征是B细胞在血液、淋巴组织和骨髓中积聚。在CLL化疗方案中加入利妥昔单抗与生存率提高相关。本研究的目的是确定Zytux™与美罗华相比在治疗CLL中的疗效和安全性。
材料和方法
70名符合入组标准的CLL患者被随机分为两组（每组35名患者）。两组均接受氟达拉滨、环磷酰胺加利妥昔单抗作为FCR方案的一部分。A组接受Zytux™治疗，B组接受美罗华治疗。主要结局的非劣效性边际定义为20%，以检验Zytux™与美罗华之间的相似性。
结果
基线人口统计学特征显示两组之间无统计学显著差异。两个治疗组在治疗周期和治疗期结束时的实验室和临床结果、细胞指数变化以及CD（5、19、20和23）计数方面具有可比性。关于安全性结果，与美罗华相比，Zytux™表现出相似的不良反应情况。此外，Zytux™和美罗华的总体缓解率分别为88%和89%（置信区间-0.17，0.18）。
结论
结果显示，作为美罗华的生物类似药，Zytux™在疗效和不良事件方面具有非劣效性。
Zotero 插件