| 1 | Bevacizumab biosimilar LY01008 compared 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显示文摘Background:Previous studies have demonstrated the preclinical pharmacological and toxicological consistency,and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized controlled trial aimed to compare 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 combination with paclitaxel/carboplatin(combined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or death.The primary endpoint was objective response rate(ORR)in accordance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 confirmed by independent radiological review committees(IRRC).Secondary endpoints included disease control rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and safety.This study was registered in Clinical Trials.gov(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)group.As of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of combined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)months.ORRof responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,respectively.The 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 LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,LY01008 and Avastin groups.There were no clinically meaningful differences in safety and immunogenicity across treatment groups.Conclusions:LY01008 demonstrated similarity to Avastin in terms of efficacy and safety in Chinese patients with advanced or recurrent non-squamous NSCLC.LY01008 combined with paclitaxel/carboplatin is expected to become a new treatment option for unresectable,metastatic,or recurrent non-squamous NSCLC patients in the first-line setting. | 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 | 2021 | Cancer Communications2021，41，9： | 5 |
| 2 | Prognostic Significance of HbA1c Level in Asian Patients with Prediabetes and Coronary Artery Disease显示文摘Background:Measuring glycosylated hemoglobin(HbA1c)is a simple way to assess patients with prediabetes or diabetes mellitus.It has been shown that HbA1c level predicts prognosis in patients with coronary artery disease(CAD)and the incidence of diabetes mellitus.However,the prognostic significance of HbA1c level in Asian patients with prediabetes and CAD is not yet clear.Our study aimed to determine the relationship between HbA1c level and major adverse cardiovascular events(MACE)in patients with prediabetes and CAD.Methods:We enrolled 1367 patients with prediabetes and CAD in the final analysis,and grouped them according to the HbA1c level.Primary end points included nonfatal myocardial infarction,hospitalization for unstable angina,and ischemia-driven revascularization.Cox proportional-hazards regression analysis was used to determine the relation-ship between HbA1c level and MACE after our accounting for confounding factors.Results:A total of 1367 patients(age 58.8±10.3 years;71.6%men)were included.During 43 months of follow-up,197 patients experienced at least one primary end point event.Multivariate Cox proportional-hazards regression analy-sis showed in comparison of HbA1c levels that the hazard ratio for primary end points was 4.110,with a 95%confidence interval of 2.097-6.011(P<0.001).Conclusions:HbA1c level positively correlated with MACE,demonstrating it is a valuable indicator for indepen-dently predicting MACE in Asian patients with prediabetes and CAD. | Yang Liu Xunxun Feng Jiaqi Yang Tienan Sun Guangyao Zhai Qianyun Guo Yujie Zhou | 2022 | Cardiovascular Innovations and Applications2022，，1： | 0 |
| 3 | A retrospective study on 464 bullous pemphigoid patients in Northeast China显示文摘To the Editor:Bullous pemphigoid(BP)is a chronic autoimmune blistering disease characterized by the association with autoantibodies to two hemidesmosomal proteins(BP180 and BP230)interfering with the adhesion of basal epidermal keratinocytes.The global incidence of BP is 2.5 to 75 cases/million per year.[1]Genetic,environmental,and stochastic factors contribute to the susceptibility to BP.We performed a retrospective study on BP in Northeast China to evaluate its clinical characteristics.The data of BP patients from Shenyang Seventh People’s Hospital between January 2015 and January 2020 were analyzed,including 464 BP patients from Northeast China. | Qiang Wang Ruiqun Qi Jianping Li Fengqiu Lin Xianwei Han Xiuyu Liang Xiaodong Sun Yue Feng Kaibo Wang Chunlin Jin Guijuan Xu Tienan Li Changhong Chu | 2022 | Chinese Medical Journal2022，，7： | 0 |
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