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| 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 | Human leukocyte antigen E in human cytomegalovirus infection: friend or foe?显示文摘人的 cytomegalovirus (HCMV ) 是一个学习得好的 -herpesvirus 病毒,它采用许多策略躲避有免疫力的监视。在感染 HCMV 的房间,古典主要 histocompatibility (MHC ) 一级分子是下面调整的,这被报导了,但是 MHC 班 Ib 分子人白血球抗原(HLA )-E 是通常表示了或甚至房间上的 overexpressed 表面。HLA-E 首先被描述了交往, CD94/NKG2 受体主要在生来的杀手(NK ) 的表面上表示了房间,因此把它的角色限制到 NK 房间的规定功能。与 HCMV glycoprotein UL40 的信号肽,有 HLA-E 的 CD94/NKG2A 的约会通常导致禁止的信号。然而, HLA-E 也为 CD8+ T 房间表示的 TCR 用作 ligand。HLA-E 介绍的肽的识别可以导致 CD8+ 受动器 T 房间激活。这些调查结果将帮助在 HCMV 感染在 HLA-E 的病原、保护的角色上更理解。在这评论,我们在 HCMV 感染关于 HLA-E 的角色讨论了最近的研究。 | Fang Gong Shengli Song Guozhong Lv Yuhong Pan Dongqing Zhang Hong Jiang | 2012 | Acta Biochimica et Biophysica Sinica2012,44,7: | 2 |
| 3 | Mefatinib as first-line treatment of patients with advanced EGFR-mutant non-small-cell lung cancer:a phase Ib/II efficacy and biomarker study显示文摘EGFR inhibitors have revolutionized the treatment of advanced non-small-cell lung cancer(NSCLC).Mefatinib is a novel,bioavailable,second-generation,irreversible pan-EGFR inhibitor.This phase Ib/II open-label,single-arm,multi-center study investigated the efficacy,safety,biomarker,and resistance mechanisms of mefatinib in the first-line treatment of patients with advanced EGFR-mutant NSCLC.This study included 106 patients with EGFR-mutant stage IIIB-IV NSCLC who received first-line mefatinib at a daily dose of either 60 mg(n=51)or 80 mg(n=55).The primary endpoint was progression-free survival(PFS).Secondary endpoints were overall response rate(ORR),disease control rate(DCR),overall survival(OS),and safety.The cohort achieved an ORR of 84.9%and DCR of 97.2%.The median PFS was 15.4 months and the median OS was 31.6 months.Brain metastasis was detected in 29%of patients(n=31)at diagnosis and demonstrated an ORR of 87.1%,PFS of 12.8 months,and OS of 25.2 months.Adverse events primarily involved skin and gastrointestinal toxicities,which were well-tolerated and manageable.Analyses of mutation profiles were performed using targeted sequencing of plasma samples at baseline,first follow-up 6 weeks from starting mefatinib therapy(F1),and at progression.Patients with concurrent TP53 mutations had comparable PFS as wild-type TP53(14.0 vs 15.4 months;p=0.315).Furthermore,circulating tumor DNA clearance was associated with longer PFS(p=0.040)and OS(p=0.002).EGFR T790M was the predominant molecular mechanism of mefatinib resistance(42.1%,16/38).First-line mefatinib provides durable PFS and an acceptable toxicity profile in patients with advanced EGFR-mutant NSCLC. | Pingli Wang Yuping Li Dongqing Lv Lingge Yang Liren Ding Jianya Zhou Wei Hong Youfei Chen Dongqing Zhang Susu He Jianying Zhou Kai Wang | 2021 | Signal Transduction and Targeted Therapy2021,6,12: | 1 |
| 4 | Short‐time wind speed prediction based on Legendre multi‐wavelet neural network显示文摘As one of the most widespread renewable energy sources,wind energy is now an important part of the power system.Accurate and appropriate wind speed forecasting has an essential impact on wind energy utilisation.However,due to the stochastic and un-certain nature of wind energy,more accurate forecasting is necessary for its more stable and safer utilisation.This paper proposes a Legendre multiwavelet‐based neural network model for non‐linear wind speed prediction.It combines the excellent properties of Legendre multi‐wavelets with the self‐learning capability of neural networks,which has rigorous mathematical theory support.It learns input‐output data pairs and shares weights within divided subintervals,which can greatly reduce computing costs.We explore the effectiveness of Legendre multi‐wavelets as an activation function.Mean-while,it is successfully being applied to wind speed prediction.In addition,the appli-cation of Legendre multi‐wavelet neural networks in a hybrid model in decomposition‐reconstruction mode to wind speed prediction problems is also discussed.Numerical results on real data sets show that the proposed model is able to achieve optimal per-formance and high prediction accuracy.In particular,the model shows a more stable performance in multi‐step prediction,illustrating its superiority. | Xiaoyang Zheng Dongqing Jia Zhihan Lv Chengyou Luo Junli Zhao Zeyu Ye | 2023 | CAAI Transactions on Intelligence Technology2023,8,3: | 0 |
| 5 | A phase II study on Mefatinib as first-line treatment of patients with advanced non-small-cell lung cancer harboring uncommon EGFR mutations显示文摘Dear Editor,Uncommon mutations in exons 18-21 of the epidermal growth factor receptor(EGFR)gene account for 10%–15%of all EGFR mutations when considered as a whole group[1,2].However,each variant confers heterogeneous clinical outcomes to different generations of EGFR tyrosine kinase inhibitors(TKIs)with G719X,L861Q,and/or S768I showing adequate sensitivity to EGFR inhibition[1–3].Osimertinib,based on its superior survival outcomes,has become the preferred first-line treatment for patients diagnosed with advanced non-small cell lung cancer(NSCLC)harboring common EGFR mutations[4];however,its efficacy in patients harboring G719X,S768I,and/or L861Q mutations was comparable or even inferior to Afatinib[5].Afatinib,a second-generation EGFR-TKI,has received approval for extended clinical indication in treating previously untreated patients with metastatic NSCLC harboring G719X,L861Q,and/or S768I based on the findings from the pooled analysis of three clinical trials(LUX-Lung 2/3/6)[2].The real-world clinical efficacy of Afatinib for treating this patient subset has been consistently demonstrated by two large retrospective studies[6,7].In China,chemotherapy remains a standard first-line treatment for this patient subset,with Afatinib available only as an off-label treatment option. | Pingli Wang Liming Cao Panwen Tian Shengxiang Ren Liyun Miao Chengzhi Zhou Yun Fan Yuping Li Dongqing Lv Xin Zhao Mei Yang Chaonan Zhu Bing Yu June Xu Yong Song Kai Wang | 2023 | Cancer Communications2023,43,9: | 0 |