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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

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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

Assembly and release of infectious hepatitis C virus involving unusual organization of the secretory pathway

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World Journal of Hepatology 2016年第19期8卷 796-814页

作者： Miriam Triyatni Edward A Berger Bertrand Saunier roche Innovation Center Roche Pharma Research and Early Development F. Hoffmann-La Roche Ltd. Molecular Structure Section Laboratory of Viral Diseases NIAID NIH Unité de Virologie Structurale Institut Pasteur and CNRS UMR 3569

AIM: To determine if calnexin(CANX), RAB1 and alphatubulin were involved in the production of hepatitis C virus(HCV) particles by baby hamster kidney-West Nile virus(BHK-WNV) cells. METHODS: Using a si RNA-based approach complemented with immuno-fluorescence confocal microscope and Western blot studies, we examined the roles of CANX, RAB1 and alpha-tubulin in the production of HCV particles by permissive BHK-WNV cells expressing HCV structural proteins or the full-length genome of HCV genotype 1a. Immuno-fluorescence studies in producer cells were performed with monoclonal antibodies against HCV structural proteins, as well as immunoglobulin from the serum of a patient recently cured from an HCV infection of same genotype. The cellular compartment stained by the serum immunoglobulin was also observedin thin section transmission electron microscopy. These findings were compared with the JfH-1 strain/Huh-7.5 cell model.RESULTS: We found that CANX was necessary for the production of HCV particles by BHK-WNV cells. This process involved the recruitment of a subset of HCV proteins, detected by immunoglobulin of an HCV-cured patient, in a compartment of rearranged membranes bypassing the endoplasmic reticulum-Golgi intermediary compartment and surrounded by mitochondria. It also involved the maturation of N-linked glycans on HCV envelope proteins, which was required for assembly and/or secretion of HCV particles. The formation of this specialized compartment required RAB1; upon expression of HCV structural genes, this compartment developed large vesicles with viral particles. RAB1 and alpha-tubulin were required for the release of HCV particles. These cellular factors were also involved in the production of HCVcc in the JfH-1 strain/Huh-7.5 cell system, which involves HCV RNA replication. The secretion of HCV particles by BHK-WNV cells presents similarities with a pathway involving caspase-1; a caspase-1 inhibitor was found to suppress the production of HCV particles from a full-length genome.CONCLUSION: Prior activity

关键词： Membrane rearrangements Hepatitis C virus flavivirus replicon Virus assembly and secretion Host cell

Exploring the utility of the Chasing Principle:influence of drug-free SNEDDS composition on solubilization of carvedilol, cinnarizine and R3040 in aqueous suspension

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Acta Pharmaceutica Sinica B 2019年第1期9卷 194-201页

作者： Scheyla Daniela Siqueira J?rgensen Thomas Rades Huiling Mu Kirsten Graeser Anette Müllertz Department of Pharmacy Faculty of Health and Medical Sciences University of Copenhagen roche Pharma Research and Development Therapeutic Modalities Roche Innovation Center Basel

This study assessed the influence of the composition of drug-free SNEDDS co-dosed with aqueous suspensions of carvedilol(CAR), cinnarizine(CIN) or R3040 on drug solubilization in a twocompartment in vitro lipolysis model. Correlation of drug log P or solubility in SNEDDS with drug solubilization during in vitro lipolysis in the presence of drug-free SNEDDS was assessed. SNEDDS with varying ratios of soybean oil:Maisine 35-1(1:1, w/w) and Kolliphor RH40, with ethanol at 10%(w/w) were used. SNEDDS were named f65, f55 and f20(numbers refer to the percentage of lipids) and aqueous suspensions without drug-free SNEDDS(f0) were also analyzed. While the ranking order of drug solubilization was f65? f55? f204f0 for CAR; f65? f554f204f0 for CIN and f65? f55? f204f0 for R3040-with higher CAR solubilization than for R3040 and CIN-the ranking of S_(eq)of CAR, CIN and R3040 in SNEDDS was f65 o f55o f20, f65? f554f20 and f654f554f20, respectively. Therefore, the composition of SNEDDS influenced the solubilization of CIN, but not CAR and R3040. furthermore, high S_(eq) in SNEDDS did not reflect high drug solubilization. As CAR(log P 3.8) showed higher solubilization than CIN(log P 5.8) and R3040(log P 10.4), a correlation between drug log P and drug solubilization was observed.

关键词： Self-nanoemulsiying drug delivery system(SNEDDS) Chasing principle Two-compartment in vitro lipolysis Rat gastrointestinal conditions Drug solubilization

Estimation of Time to Maximum Rate Under Adiabatic Conditions(TMR_(ad)) Using Kinetic Parameters Derived from DSC-Investigation of Thermal Behavior of 3-Methyl-4-Nitrophenol

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化学推进剂与高分子材料 2011年第1期9卷 84-96页

作者： Bertrand Roduit Patrick folly Alexandre Sarbach Beat Berger franz Brogli francesco Mascarello Mischa Schwaninger Thomas Glarner Eberhard Irle fritz Tobler Jacques Wiss Markus Luginbühl Craig Williams Pierre Reuse francis Stoessel AKTS AG TechnoArk 13960 SidersSwitzerland Armasuisse Science and Technology Centre3602 ThunSwitzerland Ciba Schweizerhalle AG P.O.Box4002 BaselSwitzerland DSM Nutritional Products ltd. Safety laboratory4334 SisselnSwitzerland f.hoffmann-la roche ltd Safety laboratories4070 BaselSwitzerland Lonza AG Safety Laboratory VispRottenstr.63930 Visp Switzerland Novartis Pharma AG Novartis CampusWSJ-145.8.544002 BaselSwitzerland Syngenta Crop Protection Münchwilen AG WMU 3120.1.544333 MünchwilenSwitzerland Swiss Safety Institute Schwarzwaldallee 215WRO-1055.5.024002 BaselSwitzerland

Kinetic parameters of the decomposition of hazardous chemicals can be applied for the estimation of their thermal behavior under any temperature profile.Presented paper describes the application of the advanced kinetic approach for the determination of the thermal behavior also under adiabatic conditions occurring e.***.in batch reactors in case of cooling failure.The kinetics of the decomposition of different samples(different manufacturers and batches) of 3-methyl-4-nitrophenol were investigated by conventional DSC in non-isothermal(few heating rates varying from 0.25 to 8.0K/min) and isothermal(range of 200~260℃) modes.The kinetic parameters obtained with AKTS-Thermokinetics Software were applied for calculating reaction rate and progress under different heating rates and temperatures and verified by comparing simulated and experimental signals.After application of the heat balance to compare the amount of heat generated during reaction and its removal from the system,the knowledge of reaction rate at any temperature profiles allowed the determination of the temperature increase due to the self-heating in adiabatic and pseudo-adiabatic conditions.Applied advanced kinetic approach allowed simulation the course of the Heat-Wait-Search(HWS) mode of operation of adiabatic calorimeters.The thermal safety diagram depicting dependence of Time to Maximum Rate(TMR) on the initial temperature was calculated and compared with the results of HWS experiments carried out in the system with Ф-factor amounting to 3.2.The influence of the Ф-factor and reaction progress reached at the end of the HWS monitoring on the TMR is discussed.Presented calculations clearly indicate that even very minor reaction progress reduces the TMRad of 24h characteristic for a sample with initial reaction progress amounting to zero.Described estimation method can be verified by just one HWS-ARC,or by one correctly chosen ISO-ARC run of reasonable duration by knowing in advance the dependence of the TMR on the initial temperature for any Ф-factor.Prop

关键词： adiabatic condition methyl nitrophenol DSC Ф-factor kinetics thermal runaway,TMR

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COMT抑制剂:药代动力学和药效学比较

上海医药 1998年第10期19卷 34-37页

作者： Karin M.Jorga 陈生弟 Department of Clinical Pharmacology F. Hoffmann-La Roche Ltd Basel Switzerland 上海第二医科大学附属瑞金医院

儿茶酚—氧位-甲基转移酶(COMT)可代谢带有儿茶酚基团的化合物(如左旋多巴)。抑制COMT可阻止左旋多巴甲基化,减少3-氧-甲基多巴(3-OMD)的形成,因而可改善左旋多巴的药代动力学。通过稳定血浆左旋多巴浓度,COMT抑制剂可改善帕金森症病人... 详细信息

儿茶酚—氧位-甲基转移酶(COMT)可代谢带有儿茶酚基团的化合物(如左旋多巴)。抑制COMT可阻止左旋多巴甲基化,减少3-氧-甲基多巴(3-OMD)的形成,因而可改善左旋多巴的药代动力学。通过稳定血浆左旋多巴浓度,COMT抑制剂可改善帕金森症病人对左旋多巴的疗效。两种有效的选择性、可逆性,可口服给药的COMT抑制剂,tolcapone(托卡朋)和entacapone(安托卡朋)正在临床试验中,在此对来自几项临床药理研究的数据作一总结和比较。tolcapone和entacapone对红细胞COMT活性的抑制作用均呈剂量依赖性。口服单剂200mg后,tolcapone和entacapone的最大抑制效应分别为90％和70％。与entacapone相比,tolcapone抑制作用的持续时间明显长一些。两种化合物均可增加左旋多巴的生物利用度,亦即血浆农度-时间曲线下面积(AUC)。对于tolcapone,最大作用(AUC增加94％)的剂量为200mg,而对于entacapone,其剂量为200mg和400mg时,AUC分别增加42％和65％。使用200mg tolcapone和entacapone后,血浆3-OMD浓度分别下降59％和45％。两种药物均可迅速吸收,在200mg时仍表现出线性药代动力学特性。entacapone的分布容积要大于tolcapone,从体内清除的速度更为迅速;因此,相似剂量的entacapone所产生血浆浓度要明显低于tolcapone。

关键词： COMT抑制剂多巴胺药代动力学药理震颤性麻痹

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

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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

Pertuzumab in combination with trastuzumab and chemotherapy for Chinese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer:a subpopulation analysis of the JACOB trial

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Cancer Communications 2019年第1期39卷 354-363页

作者： Tianshu Liu Yanru Qin Jin Li Ruihua Xu Jianming Xu Shujun Yang Shukui Qin Yuxian Bai Changping Wu Yixiang Mao Haiyan Wu Yilin Ge Lin Shen Department of Oncology Zhongshan HospitalFudan UniversityShanghai 200032P.R.China Department of Clinical Oncology The First Affiliated HospitalZhengzhou UniversityZhengzhou 450052HenanP.R.China Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032P.R.China Department of Oncology Tongji University Eastern HospitalShanghai 200120P.R.China Department of Medical Oncology Sun Yat-Sen University Cancer CenterGuangzhou 510060Guang-dongP.R.China Department of Oncology 307th Hospital of PLAAcademy of Military Medical SciencesBeijing 100071P.R.China Department of Medical Oncology Affiliated Cancer Hospital of Zhengzhou UniversityHenan Cancer HospitalZhengzhou 450008HenanP.R.China Department of Oncology People’s Liberation Army(PLA)Cancer Center81st Hospital of PLANanjing 210002JiangsuP.R.China Medical Department Harbin Medical University Cancer HospitalHarbin 150081HeilongjiangP.R.China Department of Oncology First People’s Hospital of ChangzhouChangzhou 213003JiangsuP.R.China roche(China)Holding Co. Ltd.Shanghai 201203P.R.China Medical Division Shanghai Roche Pharmaceuticals Ltd.Shanghai 201203P.R.China Key laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of Gastrointestinal OncologyPeking University Cancer Hospital and Institute#52 Fucheng RoadHaidian DistrictBeijing 100142P.R.China

Background:The JACOB trial(NCT01774786)was a double-blinded,placebo-controlled,randomized,multicenter,international,phase III trial evaluating the efficacy and safety of adding pertuzumab to trastuzumab and chemo-therapy in first-line treatment of human epidermal growth factor receptor 2(HER2)-positive metastatic gastric cancer/gastroesophageal junction cancer(GEJC).The aim of this analysis was to investigate efficacy and safety outcomes in the Chinese subpopulation from the JACOB trial.Methods:This post hoc subpopulation analysis included all patients recruited in China's Mainland(n=163;20.9%)between June 2013 and January 2016.The patients were randomly assigned in a 1:1 ratio to receive pertuzumab plus trastuzumab and chemotherapy(pertuzumab group;n=82)or placebo plus trastuzumab and chemotherapy(con-trol group;n=81).Intravenous pertuzumab(840 mg)and trastuzumab(8 mg/kg loading and 6 mg/kg maintenance doses)were given every 3 weeks until disease progression or unacceptable toxicity.Chemotherapy was given as per standard regimens/doses of capecitabine or 5-fluorouracil plus cisplatin.The primary endpoint was overall survival(OS);secondary efficacy endpoints included progression-free survival(PfS),and overall objective response rate(ORR).Results:The median OS was 18.7 months in the pertuzumab group and 16.1 months in the control group(hazard ratio[HR]0.75;95%confidence interval[CI]0.49 to 1.14).The median PfS was 10.5 and 8.6 months in the pertuzumab and control groups,respectively(HR 0.85;95%CI 0.60 to 1.21),and the median ORRs were 68.9%and 55.7%,respectively.The treatment effect in this Chinese subpopulation showed consistency with that in the global ITT population with numerically lower HR for OS and PfS compared with the control group.The safety profiles of the pertuzumab and control groups in this Chinese subpopulation analysis were generally comparable.The most common grade 3-5adverse events were neutropenia,anemia,and leukopenia.However,due to the nature of being a post hoc subgroup analysis,the results p

关键词： Gastric cancer Gastroesophageal junction cancer HER2 Pertuzumab Trastuzumab Chemotherapy Overall survival Progression-free survival Safety China

IMpower210:A phase Ⅲ study of second-line atezolizumab vs. docetaxel in East Asian patients with non-small cell lung cancer

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Chinese Journal of Cancer Research 2024年第2期36卷 103-113页

作者： Yi-Long Wu Shun Lu Gongyan Chen Jianxing He Jifeng feng Yiping Zhang Liyan Jiang Hongming Pan Jianhua Chang Jian fang Amy Cai Lilian Bu Jane Shi Jinjing Xia Guangdong Lung Cancer Institute Guangdong Provincial Key Laboratory of Translational Medicine in Lung CancerGuangdong Provincial People's Hospital&Guangdong Academy of Medical SciencesSouthern Medical UniversityGuangzhou 510080China Shanghai Lung Cancer Center Shanghai Chest HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200025China Department of Respiration Harbin Cancer HospitalHarbin Medical UniversityHarbin 150081China Department of Thoracic Oncology and Surgery the First Affliated Hospital of Guangzhou Medical UniversityGuangzhou 510120China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210009China Department of Medical Oncology Zhejiang Cancer HospitalHangzhou 330022China Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Department of Medical Oncology Sir Run Run Shaw HospitalZhejiang University School of MedicineHangzhou 310016China Department of Medical Oncology Shenzhen HospitalCancer Hospital of Chinese Academy of Medical SciencesShenzhen 518116China Department of Thoracic Oncology Beijing Cancer HospitalBeijing 100142China Product Development Shanghai Roche Pharmaceutical LtdShanghai 201203China

Objective: IMpower210(NCT02813785) explored the efficacy and safety of single-agent atezolizumab vs.docetaxel as second-line treatment for advanced non-small cell lung cancer(NSCLC) in East Asian patients.Methods: Key eligibility criteria for this phase Ⅲ, open-label, randomized study included age ≥18 years;histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system(7th edition);Eastern Cooperative Oncology Group performance status of 0 or 1;and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab(1,200 mg) or docetaxel(75 mg/m^(2)). The primary study endpoint was overall survival(OS) in the intention-to-treat(ITT) population with wild-type epidermal growth factor receptor expression(ITT EGfR-WT) and in the overall ITT population.Results: Median OS in the ITT EGfR-WT population(n=467) was 12.3 [95% confidence interval(95% CI),10.3-13.8] months in the atezolizumab arm(n=312) and 9.9(95% CI, 7.8-13.9) months in the docetaxel arm[n=155;stratified hazard ratio(HR), 0.82;95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5(95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1(95% CI, 8.4-14.2) months(n=377) with docetaxel treatment(n=188;stratified HR, 0.87;95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events(TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel arm.Conclusions: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGfR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade3/4 TRAEs.

关键词： Atezolizumab East Asia non-small cell lung cancer programmed death-ligand 1 inhibitors monoclonal antibody

Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer： findings from the ATHENA study

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Chinese Medical Journal 2012年第5期125卷 764-769页

作者： XU Bing-he JIANG Ze-fei SHEN Zhen-zhou GUAN Zhong-zhen CHEN Zheng-dong CHENG Ying ZHENG Hong JIANG Jun WANG Xiao-jia TONG Zhong-sheng QIN Shu-kui LUO Yi YAO Min WANG Li-wei HE Jing Cancer Hospital and Institute Chinese Academy of Medical Sciences Beijing 100021 China Breast Cancer Department 307 Hospital Cancer Center Beijing 100071 China fudan University Shanghai Cancer Center Shanghai 200032 China Cancer Center SunYat-Sen University Guangzhou Guangdong 510060 China Department of Oncology the First Affiliated Hospital of Anhui Medical University Hefei Anhui 230022 China Jili-n Province Cancer tSIospital Changchun Jilin-130012 China West China Hospital Sichuan University Chengdu Sichuan 610041 China Breast Surgery Center Chongqing Southwest Hospital Chongqing 400038 China 15th Division of Hematology ＆ Oncology Zhejiang Cancer Hospital Hangzhou Zhejiang 310022 China Breast Cancer Department Tianjin Cancer Hospital Tianjin 300060 China Department of Oncology People＇s Liberation Army Cancer Center of Nanjing Bayi Hospital Nanjing Jiangsu 210002 China Hunan Cancer Hospital. Changsha Hunan 410013 China Department of Oncology the First Affiliated Hospital of Soochow University Suzhou Jiangsu 215006 China Shanghai Jiaotong University Affiliated Shanghai first People＇s Hospital Shanghai 200082 China roche Product Development in Asia Pacific Beijing 100022 China

Background Three randomised trials have demonstrated that combining bevacizumab with first-line chemotherapy significantly improves progression-free survival versus chemotherapy alone in HER2-negative locally recurrent/metastatic breast cancer （LR/mBC）. However, data from Chinese populations are limited and possible differences between ethnic and geographic populations are unknown. This study was conducted to determine whether there are differences in safety and efficacy in patients with HER2-negative LR/mRC between Chinese and Western populations after they receive first-line bevacizumab combined with taxane-based therapy.

关键词： bevacizumab metastatic breast cancer angiogenesis first-line Chinese docetaxel