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排序方式: 共有1331条查询结果,搜索用时 31 毫秒
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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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Maud Kamal Sonia Lameiras Marc Deloger Adeline Morel Sophie Vacher Charlotte Lecerf Clia Dupain Emmanuelle Jeannot Elodie Girard Sylvain Baulande Coraline Dubot Gemma Kenter Ekaterina S. Jordanova Els M. J. J. Berns Guillaume Bataillon Marina Popovic Roman Rouzier Wulfran Cacheux Christophe Le Tourneau Alain Nicolas Nicolas Servant Suzy M. Scholl Ivan Biche RAIDs Consortium 《British journal of cancer》2021,124(4):777
Background Cervical cancer (CC) remains a leading cause of gynaecological cancer-related mortality with infection by human papilloma virus (HPV) being the most important risk factor. We analysed the association between different viral integration signatures, clinical parameters and outcome in pre-treated CCs.Methods Different integration signatures were identified using HPV double capture followed by next-generation sequencing (NGS) in 272 CC patients from the BioRAIDs study []. Correlations between HPV integration signatures and clinical, biological and molecular features were assessed.Results Episomal HPV was much less frequent in CC as compared to anal carcinoma (p < 0.0001). We identified >300 different HPV-chromosomal junctions (inter- or intra-genic). The most frequent integration site in CC was in MACROD2 gene followed by MIPOL1/TTC6 and TP63. HPV integration signatures were not associated with histological subtype, FIGO staging, treatment or PFS. HPVs were more frequently episomal in PIK3CA mutated tumours (p = 0.023). Viral integration type was dependent on HPV genotype (p < 0.0001); HPV18 and HPV45 being always integrated. High HPV copy number was associated with longer PFS (p = 0.011).Conclusions This is to our knowledge the first study assessing the prognostic value of HPV integration in a prospectively annotated CC cohort, which detects a hotspot of HPV integration at MACROD2; involved in impaired PARP1 activity and chromosome instability.Subject terms: NCT02428842Oncology, Molecular medicine, Biomarkers, Molecular biology 相似文献
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Jadwiga Najib Ekaterina Didenko Daria Meleshkina Kamila Yusupov Kateryna Maw Justin Ramnarain 《Current medical research and opinion》2020,36(10):1717-1735
Abstract
Objective
Lisdexamfetamine dimesylate is a stimulant prodrug with low abuse and diversion potential that is used in treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. This current literature review article aims to examine safety and efficacy of LDX in children and adolescents for the treatment of ADHD based on currently available data. 相似文献9.
Denis A. Mogilenko Oleg Shpynov Prabhakar Sairam Andhey Laura Arthur Amanda Swain Ekaterina Esaulova Simone Brioschi Irina Shchukina Martina Kerndl Monika Bambouskova Zhangting Yao Anwesha Laha Konstantin Zaitsev Samantha Burdess Susan Gillfilan Sheila A. Stewart Marco Colonna Maxim N. Artyomov 《Immunity》2021,54(1):99-115.e12
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Dmitrii I. Shiriaev Alina A. Sofronova Ekaterina A. Berdnikovich Dmitrii A. Lukianov Ekaterina S. Komarova Valeriya I. Marina Yuliya V. Zakalyukina Mikhail V. Biryukov Tinashe P. Maviza Yan A. Ivanenkov Petr V. Sergiev Ilya A. Osterman Olga A. Dontsova 《Antimicrobial agents and chemotherapy》2021,65(5)