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  

作　　者：Xiaonan Hong Yuqin Song Yuankai Shi Qingyuan Zhang Wei Guo Gang Wu Junmin Li Jifeng Feng Anastasiia Kinkolykh Andrea Knapp Tongyu Lin 

机构地区：[1]Department of Medical Oncology,Fudan University Shanghai Cancer Center,Shanghai 200032,China [2]Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education),Peking University Cancer Hospital and Institute,Beijing 100142,China [3]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,Beijing 100021,China [4]Department of Medical Oncology,Harbin Medical University Cancer Hospital,Harbin Medical University,Harbin,Heilongjiang 150081,China [5]Department of Hematology,The First Hospital of Jilin University,Changchun,Jilin 130015,China [6]Department of Medical Oncology,Cancer Center,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,Hubei 430023,China [7]Shanghai Institute of Hematology,State Key Laboratory of Medical Genomics,National Research Center for Translational Medicine at Shanghai,Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China [8]Department of Medical Oncology,Jiangsu Cancer Hospital,Nanjing Medical University Affiliated Cancer Hospital,Nanjing,Jiangsu 210009,China [9]Consultant to F.Hoffmann-La Roche Ltd,Basel,Switzerland,via GCE Solutions-an IQVIA business,Switzerland [10]Product Development Oncology,F.Hoffmann-La Roche Ltd,Basel,Switzerland [11]Department of Medical Oncology,Sun Yat-Sen University Cancer Center,State Key Laboratory of Oncology in South China,and Collaborative Innovation Center for Cancer Medicine,Guangzhou,Guangdong 510075,China

出　　处：《Chinese Medical Journal》2022年第4期433-440,共8页中华医学杂志（英文版）

基　　金：The GALLIUM study was sponsored by F.Hoffmann-La Roche Ltd。

摘　　要：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 

分 类 号：R733.1[医药卫生—肿瘤]