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

作     者：Yan Qin Yuqin Song Zhixiang Shen Xin Du Wei Ji Wanling Hsu Jun Zhu Yuankai Shi 

作者机构：Department of Medical OncologyBeijing 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 LymphomaBeijing Cancer HospitalPeking UniversityBeijing 100142P.R.China Department of HematologyRuijin HospitalShanghai Jiaotong UniversityShanghai 200025P.R.China Department of HematologyGuangdong General Hospital/Guangdong Academy of Medical SciencesGuangzhou 510030GuangdongP.R.China Clinical ScienceShanghai Roche Pharmaceuticals LtdShanghai 201203P.R.China StatisticsRoche(China)Holding LtdShanghai 201203P.R.China 

出 版 物：《Cancer Communications》 (癌症通讯（英文）)

年 卷 期：2018年第38卷第1期

页      面：335-343页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：GERSHWIN was sponsored by F.Hoffmann-La Roche Ltd.Medical Writing support under the direction of the lead author,was provided by Elizabeth Johnson of Gardiner-Caldwell Communications,and was funded by F.Hoffmann-La Roche Ltd 

主　　题：Obinutuzumab B-cell lymphoma Chronic lymphocytic leukemia Chinese patients 

摘      要：Background:Patients with relapsed/refractory B-cell lymphomas have limited treatment *** 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 *** 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 *** cycle lasted for 21 days;the treatment period was 24 *** subjects receiving at least one dose of obinutuzumab were included in the analysis of safety,efficacy,as well as ***: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 ***-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 ***: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.