检索结果-南通市图书馆

Efficacy and safety of Obinutuzumab for the first-line treatment of follicular lymphoma:a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study

引用

Chinese Medical Journal 2022年第4期135卷 433-440页

作者： Xiaonan Hong Yuqin Song Yuankai Shi Qingyuan Zhang Wei Guo Gang Wu Junmin Li Jifeng Feng Anastasiia Kinkolykh Andrea Knapp Tongyu Lin Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Peking University Cancer Hospital and InstituteBeijing 100142China National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin Medical UniversityHarbinHeilongjiang 150081China Department of Hematology The First Hospital of Jilin UniversityChangchunJilin 130015China Department of Medical Oncology Cancer CenterUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430023China Shanghai Institute of Hematology State Key Laboratory of Medical GenomicsNational Research Center for Translational Medicine at ShanghaiRuijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200025China Department of Medical Oncology Jiangsu Cancer HospitalNanjing Medical University Affiliated Cancer HospitalNanjingJiangsu 210009China Consultant to F.Hoffmann-La Roche Ltd BaselSwitzerlandvia GCE Solutions-an IQVIA businessSwitzerland Product Development Oncology F.Hoffmann-La Roche LtdBaselSwitzerland Department of Medical Oncology Sun Yat-Sen University Cancer CenterState Key Laboratory of Oncology in South Chinaand Collaborative Innovation Center for Cancer MedicineGuangzhouGuangdong 510075China

Backgrounds:GALLIUM is a global phase Ⅲ study that demonstrated significant improvements in progression-free survival(PFS)for Obinutuzumab plus chemotherapy(G-chemo)vs.rituximab plus chemotherapy(R-chemo)in previously untreated patients with follicular lymphoma(FL).This study aimed to report the results of a subgroup of patients in China.Methods:Patients were randomized to G-chemo or R-chemo.Responders received maintenance therapy for 2 years or until disease progression.The primary endpoint was investigator(INV)-assessed PFS.Secondary endpoints included the overall response rate(ORR)and complete response rate(CRR)at the end of induction chemotherapy,overall survival(OS),and safety.Results:Overall,58 patients with FL were randomized to the G-chemo(n=25)and R-chemo arms(n=33).The INV-assessed PFS rate at 3 years was 81.8%in the G-chemo arm,vs.70.2%in the R-chemo arm(hazard ratio 0.35;95%confidence interval:0.09-1.34;P=0.1120).The INV-assessed CRRs(without positron emission tomography[PET])in these arms were 24.0%and 21.2%,respectively,whereas the ORRs were 80.0%and 90.9%,respectively.INV-assessed CRR-PET was 52.6%in the G-chemo,vs.60.9%in the R-chemo.Median OS was not reached in either arm.Grade 3 to 5 adverse events were more frequent in the R-chemo arm(97.0%vs.88.0%).Conclusions:The results of this subgroup analysis were consistent with those of the global population,and they suggest that G-chemo has a positive benefit-risk profile in patients from China with FL.Trial registration:ClinicalTrials.gov,No.NCT01332968.

关键词： Chinese Follicular lymphoma GALLIUM Obinutuzumab Rituximab

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

Obinutuzumab治疗中国B细胞淋巴瘤患者的安全性和有效性:GERSHWIN试验的二次分析

引用

癌症 2019年第2期38卷 67-75页

作者： Yan Qin Yuqin Song Zhixiang Shen Xin Du Wei Ji Wanling Hsu Jun Zhu Yuankai Shi 肿瘤内科抗肿瘤分子靶向药物临床研究北京市重点实验室国家癌症中心/肿瘤医院中国医学科学院和北京协和医学院淋巴瘤科北京肿瘤医院北京大学血液科瑞金医院上海交通大学血液科广东省人民医院/广东省医学科学院临床科学部上海罗氏制药有限公司统计学部罗氏(中国)投资有限公司

背景与目的可供复发/难治性B细胞淋巴瘤患者选择的治疗方案很有限。GERSHWIN是一项研究Obinutuzumab单药治疗经组织学确认的CD20+复发/难治性慢性淋巴细胞白血病(chronic lymphocytic leukemia,CLL)、弥漫性大B细胞淋巴瘤(diffuse large... 详细信息

背景与目的可供复发/难治性B细胞淋巴瘤患者选择的治疗方案很有限。GERSHWIN是一项研究Obinutuzumab单药治疗经组织学确认的CD20+复发/难治性慢性淋巴细胞白血病(chronic lymphocytic leukemia,CLL)、弥漫性大B细胞淋巴瘤(diffuse large B-cell lymphoma,DLBCL)或滤泡性淋巴瘤(follicular lymphoma,FL)中国患者的疗效的开放标签、单臂、Ib期研究。先前已经报道了药代动力学的主要结局指标,在本研究中我们将报道次要终点指标(例如安全性、有效性和药效学)。方法在第1疗程的第1、8和15 d以及第2–8疗程的第1 d分别对患者静脉注射1000 mg Obinutuzumab(CLL患者的首次给药分2 d进行)。每疗程为21 d,治疗24周。注射至少1次Obinutuzumab的所有受试者均被纳入安全性、有效性以及药效学分析。结果共纳入48例(> 18岁)(CLL:12例;DLBCL:23例;FL:13例)患者,入组前接受了中位数为二线的治疗。35例(72.9%)患者出现至少1次不良事件(adverse event,AE)。最常见的AE是输液相关反应(15例;31.3%),其次是发热(11例;22.9%)。有28例(58.3%)患者出现与治疗相关的AE,其中1例死亡(间质性肺病)。治疗结束时(End-of-treatment,EoT)缓解率为33.3%,最佳总缓解率为47.9%。大多数CLL患者在EoT部分缓解(58.3%)。75.0%CLL患者及全部FL和DLBCL患者均出现CD19+减少。结论 Obinutuzumab单药治疗中国B细胞淋巴瘤患者的安全性和有效性与以往非中国患者的研究结果相似,没有观察到新的安全性指标。

关键词： Obinutuzumab B细胞淋巴瘤慢性淋巴细胞白血病中国患者

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

治疗慢性淋巴细胞白血病新药Obinutuzumab的药理作用及临床评价

引用

中国新药杂志 2014年第11期23卷 1227-1229页

作者：赵楠周颖赵侠崔一民北京大学第一医院药剂科北京100034

Obinutuzumab(GazyvaTM,GA101)是一种糖化人源化抗CD20单克隆抗体。于2013年11月以突破性治疗药物资格获美国FDA批准,用于和苯丁酸氮芥联合治疗既往未治疗的慢性淋巴细胞白血病(CLL)。BO21004第Ia阶段研究表明,与苯丁酸氮芥单药治疗相比... 详细信息

Obinutuzumab(GazyvaTM,GA101)是一种糖化人源化抗CD20单克隆抗体。于2013年11月以突破性治疗药物资格获美国FDA批准,用于和苯丁酸氮芥联合治疗既往未治疗的慢性淋巴细胞白血病(CLL)。BO21004第Ia阶段研究表明,与苯丁酸氮芥单药治疗相比,Obinutuzumab联合苯丁酸氮芥治疗可显著降低疾病进展或死亡的风险,疾病无进展生存期显著延长。最常见的3/4级不良事件为中性粒细胞减少、输注反应、血小板减少、白细胞减少和贫血。Obinutuzumab为临床CLL的治疗提供了新选择,其用于CLL或非霍奇金淋巴瘤(NHL)治疗的临床试验还在进行中。

关键词： Obinutuzumab 抗CD20单克隆抗体慢性淋巴细胞白血病

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

Safety and efficacy of Obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial

引用

Cancer Communications 2018年第1期38卷 335-343页

作者： Yan Qin Yuqin Song Zhixiang Shen Xin Du Wei Ji Wanling Hsu Jun Zhu Yuankai Shi Department of Medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsNational Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Department of Lymphoma Beijing Cancer HospitalPeking UniversityBeijing 100142P.R.China Department of Hematology Ruijin HospitalShanghai Jiaotong UniversityShanghai 200025P.R.China Department of Hematology Guangdong General Hospital/Guangdong Academy of Medical SciencesGuangzhou 510030GuangdongP.R.China Clinical Science Shanghai Roche Pharmaceuticals LtdShanghai 201203P.R.China Statistics Roche(China)Holding LtdShanghai 201203P.R.China

Background:Patients with relapsed/refractory B-cell lymphomas have limited treatment options.GERSHWIN is an open-label,single-arm,phase Ib study of Obinutuzumab monotherapy in Chinese patients with histologically docu-mented CD20+relapsed/refractory chronic lymphocytic leukemia(CLL),diffuse large B-cell lymphoma(DLBCL),or follicular lymphoma(FL).The primary outcome measure of pharmacokinetics has been previously reported.We now present data on the secondary endpoint measures(e.g.,safety,and efficacy and pharmacodynamics).Methods:Patients received 1000 mg Obinutuzumab intravenously on days 1,8,and 15 of cycle 1(CLL patients;first dose split over 2 days),and on day 1 of cycles 2-8.Each cycle lasted for 21 days;the treatment period was 24 weeks.All subjects receiving at least one dose of Obinutuzumab were included in the analysis of safety,efficacy,as well as pharmacodynamics.Results:A total of 48 patients(>18 years of age)were enrolled(CLL:12;DLBCL:23;FL:13).The subjects received a median of two lines of anticancer treatment prior to the enrollment.Thirty-five patients(72.9%)had at least one adverse event(AE).The most frequent AE was infusion-related reactions(15 patients;31.3%),followed by pyrexia(11 patients;22.9%).Treatment-related AEs were reported in 28 patients(58.3%),and included one death(interstitial lung disease).End-of-treatment(EoT)response rate was 33.3%.Best overall response rate was 47.9%.Most CLL patients achieved a partial response at EoT(58.3%).CD19+depletion occurred in 75.0%of the patients with CLL,and all patients with FL and DLBCL.Conclusions:The safety and efficacy of Obinutuzumab monotherapy in Chinese patients with B-cell lymphomas were similar to that observed in previous studies in non-Chinese patients;no new safety signals were observed.

关键词： Obinutuzumab B-cell lymphoma Chronic lymphocytic leukemia Chinese patients

来源：

维普期刊数据库评论

在线全文

维普期刊数据库

学校读者我要写书评

暂无评论

人源化抗CD20单克隆抗体Obinutuzumab

引用

药学进展 2012年第5期36卷 233-234页

作者：邢爱敏

虽然在过去的10年里,抗CD20单克隆抗体,特别是利妥昔单抗（rituximab）的出现,极大地改善了B细胞恶性淋巴瘤的治疗效果,但该病的短期复发率仍然很高。Obinutuzumab（曾用名：afutuzumab;

关键词： Obinutuzumab 抗CD20单克隆抗体恶性肿瘤

来源：

维普期刊数据库

同方期刊数据库评论

在线全文

学校读者我要写书评

暂无评论

欢迎您,

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案：

请选择收藏分类：

通借通还

欢迎您,

建议与咨询 留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

时间限定

文献类型

馆藏选择

核心期刊

语言

文献类型

帮助

文字说明：

检索规则说明：

检索范例：

分类表

所选分类

限定检索结果

文献类型

馆藏范围

日期分布

学科分类号

主题

机构

作者

语言

在线全文

在线全文

在线全文

在线全文

在线全文

请选择保存的检索档案： 新增检索档案 确定 取消

请选择收藏分类： 新增自定义分类 确定 取消

通借通还

建议与咨询留下您的常用邮箱和电话号码，以便我们向您反馈解决方案和替代方法

请选择保存的检索档案：

请选择收藏分类：