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Vassiliki A. Papadimitrakopoulou MD Ji-Youn Han MD PhD Myung-Ju Ahn MD PhD Suresh S. Ramalingam MD Angelo Delmonte MD PhD Te-Chun Hsia MD Janessa Laskin MD Sang-We Kim MD PhD Yong He MD Chun-Ming Tsai MD Toyoaki Hida MD PhD Makoto Maemondo MD PhD Terufumi Kato MD Suzanne Jenkins DPhil Sabina Patel PhD Xiangning Huang PhD Gianluca Laus MD Aleksandra Markovets PhD Kenneth S. Thress PhD Yi-Long Wu MD Tony Mok MD 《Cancer》2020,126(2):373-380
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Tanguturi Parthasaradhireddy Kim Kye-Seong Ramakrishna Suresh 《Cancer chemotherapy and pharmacology》2020,85(4):627-639
Cancer Chemotherapy and Pharmacology - Drug resistance is a well-known phenomenon leading to a reduction in the effectiveness of pharmaceutical treatments. Resistance to chemotherapeutic agents can... 相似文献
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Irina V. Poddubnaya Sergey M. Alekseev Kamil D. Kaplanov Les M. Lukavetskyy Grigoriy B. Rekhtman Tuphan K. Dolai V. Satya Suresh Attili Carlos D. Bermúdez Aleksandr A. Isaev Ekaterina V. Chernyaeva Roman A. Ivanov 《Hematological oncology》2020,38(1):67-73
BCD-020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo. International multicenter clinical trial was conducted to compare efficacy and safety of BCD-020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1-2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied. Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD-020 or comparator 375 mg/m2 for 4 weeks. Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to 20% for 95% CI for overall response rates difference. Secondary outcomes included adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity. One hundred seventy-four patients were enrolled, 89 in BCD-020 arm and 85 in comparator arm. The overall response rate was 44.71% in BCD-020 arm and 41.89% in comparator arm. Limits of 95% confidence interval (CI) for difference of overall response rates between arms were (−12.62%-18.24%) showing equivalent efficacy. Sixty-one (68.54%) and 59 (69.41%) patients had at least one adverse event in BCD-020 arm or comparator arm, respectively. No unexpected adverse reactions were reported. Antidrug antibodies with no neutralizing activity were detected in two patients in comparator arm on day 14 further declining below detection threshold. Rituximab concentrations had equivalent pattern after intravenous administration of both drugs. Both drugs caused depletion of B-cells without significant influence on other blood cell lineages. In this study, we showed equivalent efficacy of BCD-020 and reference rituximab when used in patients with CD20-positive indolent lymphomas. We also confirmed pharmacokinetic equivalence of BCD-020 and reference rituximab. Safety profile, pharmacodynamics, and immunogenicity of BCD-020 were also comparable with those of reference rituximab. 相似文献
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