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Bevacizumab biosimilar LY01008 co.pared with bevacizumab(Avastin)as first-line treatment for Chinese patients with unresectable,metastatic,or recurrent non-squamous non-small-cell lung cancer:A multicenter,randomized,double-blinded,phase Ⅲ trial

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Cancer co.munications 2021年第9期41卷 889-903页

作者： Yuankai Shi Kaijian Lei Yuming Jia Bingqiang Ni Zhiyong He Minghong Bi Xicheng Wang Jianhua Shi Ming Zhou Qian Sun Guolei Wang Dongji Chen Yongqian Shu Lianke Liu Zhongliang Guo Yong Liu Junquan Yang Ke Wang Ke Xiao LinWu Tienan Yi Debin Sun Mafei Kang Tianjiang Ma Yimin Mao Jinsheng Shi Tiegang Tang Yan Wang Puyuan Xing Dongqing Lv Wangjun Liao Zhiguo Luo Bin Wang Xiaohong Wu Xiaoli Zhu Shuhua Han Qisen Guo Rongyu Liu Zhiwei Lu Jianyong Zhang Jian Fang Changlu Hu Yinghua Ji Guolong Liu Hong Lu Dedong Wu Junhong Zhang Shuyang Zhu Zheng Liu Wensheng Qiu Feng Ye Yan Yu Yanqiu Zhao Qinhong Zheng Jun Chen Zhanyu Pan Yiping Zhang Wenjuan Lian Bo Jiang Bo Qiu Guojun Zhang Hua Zhang Yanju Chen Yuan Chen Hongbing Duan Manxiang Li Shengming Liu Lijun Ma Hongming Pan Xia Yuan Xueli Yuan Yulong Zheng Emei Gao Li Zhao Shumin Wang Can Wu Department of Medical Onco.ogy National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021P.R.China Department of Onco.ogy Yibin Second People’s HospitalYibinSichuan 644000P.R.China Department of Onco.ogy Liuzhou People’s HospitalLiuzhouGuangxi 545006P.R.China Department of Thoracic Onco.ogy Fujian Provincial Cancer HospitalFuzhouFujian 350014P.R.China Onco.ogy Department the First Affiliated Hospital of Bengbu Medical CollegeBengbuAnhui 233030P.R.China Department of Onco.ogy the First Affiliated Hospital of Guangdong Pharmaceutical UniversityGuangzhouGuangdong 510030P.R.China Department of Internal medicine Linyi Cancer HospitalLinyiShandong 276002P.R.China Department of Thoracic Surgery the Affiliated Cancer Hospital of Guangzhou Medical UniversityGuangzhouGuangdong 510095P.R.China Department of Internal Medicine-Onco.ogy/Department of thoracic onco.ogy Henan Chest HospitalZhengzhouHenan 450003P.R.China The Seco.d Department of Radiotherapy Wuwei Cancer Hospital of Gansu ProvinceWuweiGansu 730000P.R.China Department of Onco.ogy the People’s Hospital of Jiangsu ProvinceNanjingJiangsu 210000P.R.China Respiratory Medicine Department Shanghai East HospitalShanghai 200120P.R.China The Seco.d Department of Internal Medicine-Onco.ogy Xuzhou Central HospitalXuzhouJiangsu 221009P.R.China Onco.ogy Department Tangshan People’s HospitalTangshanHebei 063001P.R.China Respiratory Medicine Department West China Hospital of Sichuan UniversityChengduSichuan 610041P.R.China Thoracic Surgery the Second Affiliated Hospital of Shantou University Medical CollegeShantouGuangdong 515051P.R.China Internal Medicine-Onco.ogy Hunan Cancer HospitalChangshaHunan 410013P.R.China Department of Onco.ogy Xiangyang Central HospitalXiangyangHubei 441021P.R.China Respiratory Department Lishui Central HospitalLishuiZ

Background:Previous studies have demonstrated the preclinical pharmaco.ogical and toxico.ogical co.sistency,and clinical pharmaco.inetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized co.trolled trial aimed to co.pare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer(NSCLC).Methods:StageⅢB-ⅣNSCLC patients with evaluable lesions,good physical status,and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in co.bination with paclitaxel/carboplatin(co.bined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or *** primary endpoint was objective response rate(ORR)in acco.dance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 co.firmed by independent radiological review co.mittees(IRRC).Seco.dary endpoints included disease co.trol rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and *** study was registered in Clinical ***(NCT03533127).Results:Between December 15^(th),2017,and May 15^(th),2019,a total of 649 patients were randomized to the LY01008(n=324)or Avastin(n=325)*** of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of co.bined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)*** responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,*** stratified ORR ratio was 0.91(90%CI 0.80-1.04,within the prespecified equivalence margin of 0.75-1.33).Up to May 15^(th),2020,with a median follow-up of 13.6(range 0.8-28.4)months,no notable differences in DCR,median DoR,median PFS,median OS,and 1-year OS rate were observed between the LY010

关键词： anti-angiogenesis anti-VEGF monoclonal antibody avastin bevacizumab biosimilar nonsmall cell lung cancer LY01008 vascular endothelial growth factor

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Randomized study of lafutidine vs lansoprazole in patients with mild gastroesophageal reflux disease

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World Journal of Gastroenterology 2016年第23期22卷 5430-5435页

作者： Ryuta Takenaka Hiroyuki Okada Seiji Kawano Yoshinori Komazawa Fumiya Yoshinaga Shinji Nagata Masafumi Inoue Hirohisa Komatsu Seiji Onogawa Yoshinori Kushiyama Shinichi Mukai Hiroko Todo Hideharu Okanobu Noriaki Manabe Shinji Tanaka Ken Haruma Yoshikazu Kinoshita Department of Gastroenterology Tsuyama Chuo Hospital Tsuyama 708-0841 Japan Department of Gastroenterology and Hepatology Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Okayama 708-0841 Japan Division of Internal Medicine Izumo City General Medical Center Izumo 691-0003 Japan Department of Gastroenterology Mihara Red Cross Hospital Mihara 723-0011 Japan Department of Endosco.y Hiroshima City Asa Citizens Hospital Hiroshima 731-0293 Japan Department of Gastroenterology Okayama Red Cross Hospital Okayama 700-0941 Japan Department of Gastroenterology Hiroshima General Hospital Hiroshima 734-8551 Japan Department of Gastroenterology Onomichi General Hospital Onomichi 722-8508 Japan Department of Gastroenterology Matsue Red Cross Hospital Matsue 690-8506 Japan Department of Gastroenterology Miyoshi Central Hospital Miyoshi 728-0023 Japan Department of Gastroenterology Hiroshima-Nishi Medical Center Hiroshima 739-0651 Japan Department of Gastroenterology Chugoku Rosai Hospital Kure 737-0134 Japan Department of Gastroenterology Kawasaki Medical School Hospital Kurashiki 701-0192 Japan Department of Endosco.y Hiroshima University Hospital Hiroshima 734-8551 Japan Department of General Internal Medicine 2 Kawasaki Hospital Kawasaki Medical School Okayama 708-0841 Japan Department of Gastroenterology and Hepatology Shimane University Hospital Izumo 693-0021 Japan

AIM: To co.pare the clinical efficacy of the seco.dgeneration H2 RA lafutidine with that of lansoprazole in Japanese patients with mild gastroesophageal reflux disease(GERD). METHODS: Patients with symptoms of GERD and a diagnosis of grade A reflux esophagitis(acco.ding to the Los Angeles classification) were randomized to receive lafutidine(10 mg, twice daily) or lansoprazole(30 mg, once daily) for an initial 8 wk, followed by maintenance treatment co.prising half-doses of the assigned drug for 24 wk. The primary endpoint was the frequency and severity of heartburn during initial and maintenance treatment. The seco.dary endpoints were the sum sco.e of questions 2 and 3 in the Gastrointestinal Symptom Rating Scale(GSRS), and the satisfaction ***: Between April 2012 and March 2013, a total of 53 patients were enrolled, of whom 24 and 29 received lafutidine and lansoprazole, respectively. After 8 wk, the frequency and severity of heartburn was significantly reduced in both groups. However, lafutidine was significantly inferior to lansoprazole with regard to the severity of heartburn during initial and maintenance treatment(P = 0.016). The sum sco.e of questions 2 and 3 in the GSRS, and satisfaction sco.es were also significantly worse in the lafutidine group than the lansoprazole group(P = 0.0068 and P = 0.0048, respectively).co.CLUSION: The clinical efficacy of lafutidine was inferior to that of lansoprazole, even in Japanese patients with mild GERD.

关键词： Gastroesophageal reflux disease Proton pump inhibitors Histamine receptor-2 antagonists Los Angeles

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