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Disitamab vedotin,a HER2-directed antibody-drug conjugate,in patients with HER2-overexpression and HER2-low advanced breast cancer:a phase I/Ib study

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Cancer Communications 2024年第7期44卷 833-851页

作者： Jiayu Wang Yunjiang Liu Qingyuan Zhang Wei Li jifeng feng XiaojiaWang Jianmin Fang Yiqun Han Binghe Xu Department of Medical Oncology Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingP.R.China Breast Center The Fourth Hospital of Hebei Medical UniversityShijiazhuangHebeiP.R.China Department of Breast Medicine Harbin Medical University Cancer HospitalHarbinHeilongjiangP.R.China Department of Medical Oncology The First Hospital of Jilin UniversityChangchunJilinP.R.China Department of Medical Oncology Jiangsu Cancer HospitalNanjingJiangsuP.R.China Department of Breast Medicine Zhejiang Cancer HospitalHangzhouZhejiangP.R.China School of Life Science and Technology Tongji UniversityShanghaiP.R.China

Background:Disitamab vedotin(DV;RC48-ADC)is an antibody-drug conjugate comprising a human epidermal growth factor receptor 2(HER2)-directed antibody,linker and monomethyl auristatin *** studies have shown that DV demonstrated potent antitumor activity in preclinical models of breast,gastric,and ovarian cancers with different levels of HER2 *** this pooled analysis,we report the safety and efficacy of DV in patients with HER2-overexpression and HER2-low advanced breast cancer(ABC).Methods:In the phase I dose-escalation study(C001 CANCER),HER2-overexpression ABC patients received DV at doses of 0.5-2.5 mg/kg once every two weeks(Q2W)until unacceptable toxicity or progressive *** dose range,safety,and pharmacokinetics(PK)were *** phase Ib dose-range and expansion study(C003 CANCER)enrolled two cohorts:HER2-overexpression ABC patients receiving DV at doses of 1.5-2.5 mg/kg Q2W,with the recommended phase 2 dose(RP2D)determined,andHER2-lowABC patients receiving DV at doses of 2.0 mg/kg Q2W to explore the efficacy and safety of DV in HER2-low ***:Twenty-four patients with HER2-overexpression ABC in C001 CANCER,46 patients with HER2-overexpressionABCand 66 patients with HER2-low ABC in C003 CANCER were *** 2.0 mg/kg RP2D Q2W,the confirmed objective response rates were 42.9%(9/21;95%confidence interval[CI]:21.8%-66.0%)and 33.3%(22/66;95%CI:22.2%-46.0%),with median progression-free survival(PFS)of 5.7 months(95%CI:5.3-8.4 months)and 5.1 months(95%CI:4.1-6.6 months)for HER2-overexpression and HER2-low ABC,***(≥5%)grade 3 or higher treatment-emergent adverse events included neutrophil count decreased(17.6%),gamma-glutamyl transferase increased(13.2%),asthenia(11.0%),white blood cell count decreased(9.6%),peripheral neuropathy such as hypoesthesia(5.9%)and neurotoxicity(0.7%),and pain(5.9%).Conclusion:DV demonstrated promising efficacy in HER2-overexpression and HER2-low ABC,with a favorable safety profile at

关键词： antibody-drug conjugate breast cancer clinical trials disitamab vedotin HER2-low HER2-overexpression

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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 *** as second-line treatment for advanced non-small cell lung cancer(NSCLC) in East Asian ***: 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 ***: 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 ***: 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

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Phase II study of novel orally PI3Kα/δinhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma

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Signal Transduction and Targeted Therapy 2024年第5期9卷 2193-2201页

作者： Huaqing Wang jifeng feng Yanyan Liu Zhengzi Qian Da Gao Xuehong Ran Hui Zhou Lihong Liu Binghua Wang Meiyun Fang Hebing Zhou Zhenqian Huang Shi Tao Zhuowen Chen Liping Su Hang Su Yu Yang Xiaobao Xie Huijing Wu Ping Sun Guoyu Hu Aibin Liang Zhiming Li Department of Oncology Tianjin Union Medical Center of Nankai UniversityTianjin 300121PR China The Institute of Translational Medicine Tianjin Union Medical Center of Nankai UniversityTianjin 300121PR China Department of Medical Oncology Jiangsu Cancer HospitalThe Affiliated Cancer Hospital of Nanjing Medical UniversityNanjing 210009PR China Department of Medical Oncology Henan Cancer HospitalThe Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhou 450003PR China Department of Medical Oncology Tianjin Medical University Cancer Institute and HospitalTianjin 300060PR China Department of Hematology The Affiliated Hospital of Inner Mongolia Medical College010050 HohhotPR China Department of Hematology Weifang People’s HospitalThe First Affiliated Hospital of Weifang Medical University261000 WeifangPR China Department of Lymphoma&Hematology Hunan Cancer HospitalThe Affiliated Cancer Hospital of Xiangya School of MedicineCentral South University410013 ChangshaPR China Department of Hematology The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital050011 ShijiazhuangPR China Department of Lymphoma Weihai Central Hospital264400 WeihaiPR China Department of Hematology and Rheumatology The Affiliated Zhongshan Hospital of Dalian University116001 DalianPR China Department of Hematology Beijing Luhe Hospital101199 BeijingPR China Department of Hematology The First Affiliated Hospital of Guangzhou Medical University510120 GuangzhouPR China Department of Hematology The First Affiliated Hospital of Hainan Medical College570102 HaikouPR China Department of Hematology The First People’s Hospital of Foshan528000 FoshanPR China Department of Hematology Shanxi Cancer Hospital030013 TaiyuanPR China Department of Lymphoma Senior Department of HematologyThe Fifth Medical Center of Chinese PLA General Hospital100039 BeijingPR China Department of Lymphoma and Head and Neck Cancer Fujian Cancer Hospital350014 FuzhouPR China Department of Hematology The First People’s Hospit

This registration study assessed clinical outcomes of TQ-B3525,the dual phosphatidylinositol-3-kinase(PI3K)α/δinhibitor,in relapsed and/or refractory follicular lymphoma(R/R FL).This phase II study(*** *** March 27,2020)comprised run-in stage and stage 2.R/R FL patients after≥2 lines therapies received oral 20 mg TQ-B3525 once daily in a 28-day cycle until intolerable toxicity or disease *** endpoint was independent review committee(IRC)-assessed objective response rate(ORR).Based on results(ORR,88.0%;duration of response[DOR],11.8 months;progression-free survival[PFS],12.0 months)in 25 patients at run-in stage,second stage study was initiated and included 82 patients for efficacy/safety *** received prior-line(median,3)therapies,with 56.1%refractory to previous last therapies;73.2%experienced POD24 at *** stage 2,ORR was 86.6%(71/82;95%CI,77.3-93.1%),with 28(34.2%)complete *** control rate was 95.1%due to 7(8.5%)stable *** time to response was 1.8 *** 71 responders,median DOR was not reached;18-month DOR rate was 51.6%.with median follow-up of 13.3 months,median PFS was 18.5(95%CI,10.2-not estimable)*** overall survival(OS)was not reached by cutoff date;24-month OS rate was estimated as 86.1%.Response rates and survival data were consistent across all *** 3 or higher treatment-related adverse events were observed in 63(76.8%)cases,with neutropenia(22.0%),hyperglycemia(19.5%),and diarrhea(13.4%)being ***-B3525 showed favorable efficacy and safety for R/R FL patients after≥2 lines prior therapies.

关键词： lymphoma assessed initiated

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Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study

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Cancer Communications 2024年第4期44卷 455-468页

作者： Jing Zheng Tao Wang Yunpeng Yang Jie Huang jifeng feng Wu Zhuang Jianhua Chen Jun Zhao Wei Zhong Yanqiu Zhao Yiping Zhang Yong Song Yi Hu Zhuang Yu Youling Gong Yuan Chen feng Ye Shucai Zhang Lejie Cao Yun Fan Gang Wu Yubiao Guo Chengzhi Zhou Kewei Ma Jian Fang Weineng feng Yunpeng Liu Zhendong Zheng Gaofeng Li Huijie Wang Shundong Cang Ning Wu Wei Song Xiaoqing Liu Shijun Zhao Lieming Ding Giovanni Selvaggi Yang Wang Shanshan Xiao Qian Wang Zhilin Shen Jianya Zhou Jianying Zhou Li Zhang Department of Respiratory Disease Thoracic Disease CenterThe First Affiliated HospitalCollege of MedicineZhejiang UniversityZhejiang Provincial Clinical Research Center for Respiratory DiseaseHangzhouZhejiangP.R.China Hangzhou Repugene Technology Co. LtdHangzhouZhejiangP.R.China Department of Medical Oncology Sun Yat-sen University Cancer Cen-terState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangzhouGuangdongP.R.China Department of Medical Oncology Jiangsu Cancer HospitalJiangsu Institute of Cancer ResearchThe Affiliated Cancer Hospital of Nanjing Medical UniversityNanjingJiangsuP.R.China Department of Thoracic Oncology Fujian Provincial Cancer HospitalFujian Medical University Cancer HospitalFuzhouFujianP.R.China Department of Medical Oncology-Chest Hunan Cancer HospitalChangshaHunanP.R.China Department of Thoracic Oncology Beijing Cancer HospitalBeijingP.R.China Department of Pulmonary Medicine Peking Union Medical College HospitalChinese Academy of Medical SciencesPeking Union Medical CollegeBeijingP.R.China Respiratory Department of Internal Medicine Henan Provincial Can-cer HospitalAffiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Thoracic Medical Oncology Zhejiang Cancer HospitalHangzhouZhejiangP.R.China Division of Respiratory Medicine Jinling HospitalNanjing University School of MedicineNanjingJiangsuP.R.China Department of Oncology Chinese People’s Liberation Army(PLA)General HospitalBeijingP.R.China Department of Oncology The Affiliated Hospital of Qingdao UniversityQingdaoShandongP.R.China Department of Thoracic Oncology Cancer CenterWest China HospitalSichuan UniversityChengduSichuanP.R.China Department of Oncology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiP.R.China Department of Medical Oncology Cancer HospitalThe First Affiliated Hospital of Xiamen UniversitySchool of MedicineXiamen UniversityTeaching Hospital of

Background:The initial phase II stuty(NCT03215693)demonstrated that ensartinib has shown clinical activity in patients with advanced crizotinib-refractory,anaplastic lymphoma kinase(ALK)-positive non-small cell lung cancer(NSCLC).Herein,we reported the updated data on overall survival(OS)and molecular profiling from the initial phase Ⅱ ***:In this study,180 patients received 225 mg of ensartinib orally once daily until disease progression,death or *** was estimated by Kaplan‒Meier methods with two-sided 95%confidence intervals(CIs).Next-generation sequencing was employed to explore prognostic biomarkers based on plasma samples collected at baseline and after initiating *** tumor DNA(ctDNA)was detected to dynamically monitor the genomic alterna-tions during treatment and indicate the existence of molecular residual disease,facilitating improvement of clinical ***:At the data cut-off date(August 31,2022),with a median follow-up time of 53.2 months,97 of 180(53.9%)patients had *** median OS was 42.8 months(95%CI:29.3-53.2 months).A total of 333 plasma samples from 168 patients were included for ctDNA *** inferior OS correlated sig-nificantly with baseline ALK or tumor protein 53(TP53)*** addition,patients with concurrent TP53 mutations had shorter OS than those without con-current TP53 *** ctDNA levels evaluated by variant allele frequency(VAF)and haploid genome equivalents per milliliter of plasma(hGE/mL)at baseline were associated with poor ***,patients with ctDNA clear-ance at 6 weeks and slow ascent growth had dramatically longer OS than those with ctDNA residual and fast ascent growth,***,patients who had a lower tumor burden,as evaluated by the diameter of target lesions,had a longer *** Cox regression analysis further uncovered the independent prognostic values of bone metastases,higher hGE,and elevated ALK mutation abundance at 6 we

关键词： anaplastic lymphoma kinase ctDNA ensartinib non-small cell lung cancer overall survival

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A new emerging target in cancer immunotherapy: Galectin-9 (LGALS9)

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Genes & Diseases 2023年第6期10卷 2366-2382页

作者： Yan Lv Xiao Ma Yuxin Ma Yuxin Du jifeng feng The Affiliated Cancer Hospital of Nanjing Medical University Jiangsu Cancer HospitalJiangsu Institute of Cancer ResearchNanjingJiangsu 210009China Department of General Surgery The Affiliated Zhongda Hospital of Southeast UniversityNanjingJiangsu 210009China

Over the past few decades, advances in immunological knowledge have led to the identification of novel immune checkpoints, reinvigorating cancer immunotherapy. Immunotherapy, represented by immune checkpoint inhibitors, has become the leader in the precision treatment of cancer, bringing a new dawn to the treatment of most cancer patients. Galectin-9 (LGALS9), a member of the galectin family, is a widely expressed protein involved in immune regulation and tumor pathogenesis, and affects the prognosis of various types of cancer. Galectin-9 regulates immune homeostasis and tumor cell survival through its interaction with its receptor Tim-3. In the review, based on a brief description of the signaling mechanisms and immunomodulatory activities of galectin-9 and Tim-3, we summarize the targeted expression patterns of galectin-9 in a variety of malignancies and the promising mechanisms of anti-galectin-9 therapy in stimulating anti-tumor immune responses.

关键词： Galectin-9 Immune checkpoint inhibitors Immunotherapy Monoclonal antibody Tim-3

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Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated,EGFR-mutated,advanced non-small cell lung cancer:data froma randomized phase III trial(AENEAS)

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Cancer Communications 2024年第9期44卷 1005-1017页

作者： Shun Lu Xiaorong Dong Hong Jian Jianhua Chen Gongyan Chen Yuping Sun Yinghua Ji ZipingWang Jianhua Shi Junguo Lu Shaoshui Chen Dongqing Lv Guojun Zhang Chunling Liu Juan Li Xinmin Yu Zhong Lin Zhuang Yu ZhehaiWang Jiuwei Cui Xingxiang Xu Jian Fang jifeng feng Zhi Xu RuiMa Jie Hu Nong Yang Xiangdong Zhou XiaohongWu Chengping Hu Zhihong Zhang You Lu Yanping Hu Liyan Jiang Qiming wang Renhua Guo Jianying Zhou Baolan Li Chunhong Hu Wancheng Tong Helong Zhang LinMa Yuan Chen Zhijun Jie Yu Yao Longzhen Zhang JieWeng Weidong Li Jianping Xiong Xianwei Ye Jianchun Duan Haihua Yang Meili Sun HongyingWei JiaweiWei Zheyu Zhang QiongWu Department of Medical Oncology Shanghai Chest Hospital Shanghai JiaoTong UniversityShanghaiP.R.China Cancer Center Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhanHubeiP.R.China Department of Medical Oncology-Chest Hunan Cancer Hospital&The Affiliated Cancer Hospital of Central South University Xiangya School of MedicineChangshaHunanP.R.China Thoracic OncologyMedicine HarbinMedical University Cancer HospitalHarbinHeilongjiangP.R.China Department of Oncology Jinan Central HospitalJinanShandongP.R.China Department of Oncology First Affiliated Hospital of Xinxiang Medical UniversityXinxiangHenanP.R.China Department of Chest Medicine Beijing Cancer HospitalBeijingP.R.China Department of Internal Medicine Linyi Cancer HospitalLinyiShandongP.R.China Department of Respiratory Medicine Nantong Tumor HospitalNantongJiangsuP.R.China Department of Oncology Binzhou Medical University HospitalBinzhouShandongP.R.China Breath Internal Medicine Taizhou Hospital of Zhejiang ProvinceLinhaiZhejiangP.R.China Department of Respiration The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China Department of Lung Internal Medicine Affiliated Tumor Hospital of Xinjiang Medical UniversityUrumqiXinjiangP.R.China Department of Thoracic Oncology Sichuan Cancer HospitalChengduSichuanP.R.China Thoracic Medical Oncology Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)HangzhouZhejiangP.R.China Department of Thoracic Oncology The Fifth Subsidiary Sun Yat-sen University HospitalZhuhaiGuangdongP.R.China Department of Oncology The Affiliated Hospital of QingdaoUniversityQingdaoShandongP.R.China Department of Oncology Shandong Cancer HospitalJinanShandongP.R.China Department of Oncology The First BethuneHospital of Jilin UniversityChangchunJilinP.R.China Department of Respiration Northern Jiangsu People’s Hospital Affiliated to Yangzhou UniversityYangzhouJiangsuP.R.China Department of Internal

Background:The initial randomized,double-blinded,actively controlled,phase III ANEAS study(NCT03849768)demonstrated that aumolertinib showed superior efficacy relative to gefitinib as first-line therapy in epidermal growth factor receptor(EGFR)-mutated advanced non-small cell lung cancer(NSCLC).Metastatic disease in the central nervous system(CNS)remains a challenge in the management of *** study aimed to compare the efficacy of aumolertinib versus gefitinib among patients with baseline CNS metastases in the ANEAS ***:Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded *** with asymptomatic,stable CNS metastases were ***-up imaging of the same modality as the initial CNS imaging was performed every 6 weeks for 15 months,then every *** responsewas assessed by a neuroradiological blinded,independent central review(neuroradiological-BICR).The primary endpoint for this subgroup analysis was CNS progression-free survival(PFS).Results:Of the 429 patients enrolled and randomized in the ANEAS study,106 patients were found to have CNS metastases(CNS Full Analysis Set,cFAS)at baseline by neuroradiological-BICR,and 60 of them had CNS target lesions(CNS Evaluable for Response,cEFR).Treatment with aumolertinib significantly prolonged median CNS PFS compared with gefitinib in both cFAS(29.0 vs.8.3 months;hazard ratio[HR]=0.31;95%confidence interval[CI],0.17-0.56;P<0.001)and cEFR(29.0 vs.8.3 months;HR=0.26;95%CI,0.11-0.57;P<0.001).The confirmed CNS overall response rate in cEFRwas 85.7%and 75.0%in patients treated with aumolertinib and gefitinib,*** risk analysis showed that the estimated probability of CNS progression without prior non-CNS progression or death was consistently lower with aumolertinib than with gefitinib in patients with and without CNSmetastases at *** new safety findings were ***:The

关键词： aumolertinib brain metastasis non-small cell lung cancer third-generation EGFR-TKI

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PD-L1介导淋巴细胞YAP磷酸化在病毒性急性肺损伤中的作用

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广西医科大学学报 2024年第2期41卷 247-254页

作者：汪子意莫健兰陈凤鸣罗碧君冯继峰广西中医药大学南宁530299 广西壮族自治区妇幼保健院麻醉科南宁530002

目的:探讨程序性死亡受体配体1(PD-L1)介导淋巴细胞yes相关蛋白(YAP)磷酸化在病毒性急性肺损伤中的作用。方法:将SPF级C57BL/6J小鼠随机分为对照组、根据小鼠气管内滴注聚肌苷—聚胞苷酸(即Poly I:C)的时间分为4 h、8 h、1 d、3 d、7 d... 详细信息

目的:探讨程序性死亡受体配体1(PD-L1)介导淋巴细胞yes相关蛋白(YAP)磷酸化在病毒性急性肺损伤中的作用。方法:将SPF级C57BL/6J小鼠随机分为对照组、根据小鼠气管内滴注聚肌苷—聚胞苷酸(即Poly I:C)的时间分为4 h、8 h、1 d、3 d、7 d组,在这五组中选取炎症损伤最严重的组作为Poly I:C组;利用PD-1/PD-L1抑制剂BMS-110mg/kg腹腔注射预处理后气管内滴注Poly I:C,作为Poly I:C+BMS-1组。野生型小鼠Poly I:C组和PD-L1敲基因小鼠Poly I:C组处理同Poly I:C组;野生型小鼠对照组和PD-L1敲基因小鼠对照组腹腔注射麻醉后气管内给予等量生理盐水。相应时间点将小鼠安乐死收集标本。采用苏木精—伊红(HE)染色法评估小鼠肺组织损伤程度;通过检测支气管肺泡灌洗液(BALF)中总蛋白浓度、总细胞数以及酶联免疫吸附法(ELISA)检测BALF中肿瘤坏死因子(TNF)-α水平评估炎症情况;蛋白免疫印迹(western blotting,WB)检测程序性死亡受体1(PD-1)、PD-L1、YAP、p-YAP蛋白表达。结果:与对照组比较,8 h、1 d、3 d、7 d组肺组织病理学损伤评分及BALF总蛋白浓度显著升高,8 h、1 d、3 d组BALF中总细胞数明显增多,4 h、8 h、1 d、3 d组BALF中TNF-α水平显著上调,差异均有统计学意义(P<0.05);其中1 d组小鼠肺组织病理学损伤评分、BALF中总蛋白浓度、BALF总细胞数以及BALF中TNF-α水平均高于4 h、8 h、3 d、7 d组。与对照组比较,1 d、3 d、7 d组小鼠肺组织中PD-1和PD-L1蛋白水平均明显升高(P<0.05)。Poly I:C组小鼠肺组织病理损伤评分和BALF中TNF-α水平明显高于对照组,与Poly I:C组相比,Poly I:C+BMS-1组小鼠肺组织病理损伤评分和BALF中TNF-α水平显著降低(P<0.05)。与对照组相比,Poly I:C组和Poly I:C+BMS-1组小鼠淋巴细胞中YAP蛋白表达明显下调,p-YAP蛋白表达显著上调(P<0.05);与Poly I:C组相比,Poly I:C+BMS-1组小鼠淋巴细胞中YAP蛋白表达上升,p-YAP蛋白表达下降(P<0.05)。与对照组相比,Poly I:C组小鼠淋巴细胞中YAP蛋白表达明显下调而p-YAP蛋白表达显著上调,PD-L1基因敲除后Poly I:C组小鼠淋巴细胞中YAP蛋白表达有所上升而p-YAP蛋白表达明显下降,差异均有统计学意义(P<0.05)。结论:病毒性急性肺损伤小鼠肺组织中高表达PD-L1蛋白,PD-L1可能通过激活淋巴细胞的YAP磷酸化加重病毒性急性肺损伤。

关键词：程序性死亡配体 yes相关蛋白急性肺损伤淋巴细胞

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莘县林业发展措施探讨

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南方农业 2024年第2期18卷 168-170页

作者：冯记锋郭鲁雷李翠敏徐华强尹义庆南晓博莘县自然资源和规划局山东252400

加快平原地区林业发展,对于维护国家粮食安全、木材安全,促进农民就业增收,推动农村生态文明建设,实现平原地区经济社会科学发展,具有重大的战略意义。为给平原地区的林业科学发展提供借鉴,以山东省莘县为例,分析现阶段影响平原地区林... 详细信息

加快平原地区林业发展,对于维护国家粮食安全、木材安全,促进农民就业增收,推动农村生态文明建设,实现平原地区经济社会科学发展,具有重大的战略意义。为给平原地区的林业科学发展提供借鉴,以山东省莘县为例,分析现阶段影响平原地区林业发展的主要因素,从明确林业发展中长期目标、做好林业发展规划、夯实林业发展基础、制订林业发展的保障性措施等方面分析促进当地林业发展的主要措施。

关键词：林业发展发展目标发展规划保障措施山东省莘县

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The relationship between treatment-induced hypertension and efficacy of anlotinib in recurrent or metastatic esophageal squamous cell carcinoma

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Cancer Biology & Medicine 2021年第2期18卷 562-568页

作者： Yan Song Juxiang Xiao Wentao Fang Ping Lu Qingxia Fan Yongqian Shu jifeng feng Shu Zhang Yi Ba Yang Zhao Ying Liu Chunmei Bai Yuxian Bai Yong Tang Jie He Jing Huang Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Medical Oncology First Hospital of Xi’an Jiaotong UniversityXi’an 710061China Department of Thoracic Surgery Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Department of Medical Oncology First Affiliated Hospital of Xinxiang Medical UniversityXinxiang 453100China Department of Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450052China Department of Oncology The First Affiliated Hospital of Nanjing Medical UniversityNanjing 210029China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210009China Department of Medical Oncology Shandong Cancer HospitalJinan 250117China Department of Medical Oncology Tianjin Medical University Cancer Institute and HospitalNational Clinical Research Center for CancerKey Laboratory of Cancer Prevention and TherapyTianjinTianjin’s Clinical Research Center for CancerTianjin 300060China Department of Biostatistics School of Public HealthNanjing Medical UniversityNanjing 210029China Department of Medical Oncology Henan Cancer HospitalZhengzhou 450008China Department of Oncology Peking Union Medical College HospitalChinese Academy of Medical SciencesBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150086China Department of Gastroenterology Affiliated Tumor HospitalXinjiang Medical UniversityUrumqi 830011China Department of Thoracic Surgical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China

Objective:In this post-hoc analysis,we evaluated anlotinib treatment-induced hypertension as a potential predictive factor of efficacy in esophageal squamous cell carcinoma(ESCC)***:A total of 109 patients enrolled in the anlotinib group in a phase 2 trial were *** tumor response was assessed by computed tomography at week 3,week 6,and then every 6 weeks until progressive disease was *** primary endpoint of the study was progression free survival(PFS).The secondary endpoints included overall survival(OS)and objective response rate(ORR).Results:In all patients,the median PFS was 3.02 months[95%confidence interval(CI):2.63–3.65 months]and the OS was 6.11 months(95%CI:4.40–7.79 months).The ORR was 7.34%(95%CI:3.22%–13.95%).A total of 59(54%)patients were diagnosed with treatment-induced hypertension(Group A),and the remaining patients(n=50,46%)were in Group *** prognostic factors were similar between the 2 *** in Group A had a longer PFS and OS and higher *** stratifying patients using a previously known history of hypertension,treatment-induced hypertension was a predictor only for patients without previous hypertension,who had longer PFS[hazard ratio(HR):0.40,95%CI:0.24–0.68]and OS(HR:0.37,95%CI:0.21–0.67).Conclusions:We showed,for the first time,a correlation between treatment-induced hypertension and better prognoses in recurrent or metastatic ESCC patients treated with anlotinib,without a previously known history of ***-induced hypertension may be a simple and low cost predictor for anlotinib antitumor efficacy in these patients,which may also reflect the intended target inhibition.

关键词： Esophageal squamous cell carcinoma(ESCC) anlotinib treatment-induced hypertension prognostic predictor antiangiogenesis

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Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01(a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma

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Chinese Journal of Cancer Research 2021年第3期33卷 405-416页

作者： Yuankai Shi Qingyuan Zhang Xiaohong Han Yan Qin Xiaoyan Ke Hang Su Li Liu Jinxiang Fu Jie Jin jifeng feng Xiaonan Hong Xiaohong Zhang Depei Wu Bin Jiang Xiaodong Dong National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Harbin Medical University Cancer Hospital Harbin 150081China Peking University Third Hospital Beijing 100191China The 307th Hospital of Military Chinese People's Liberation Army Beijing 100071China Tangdu Hospital of the Fourth Military Medical University Xi'an 710038China The Second Affiliated Hospital of Soochow University Suzhou 215004China The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou 310006China Jiangsu Cancer Hospital Nanjing 210009China Fudan University Shanghai Cancer Center Shanghai 200032China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou 310003China The First Affiliated Hospital of Soochow University Suzhou 215006China Peking University People's Hospital Beijing 100034China Shanghai Henlius Biotech Inc.Shanghai 200233China

Objective: This study aimed to compare the pharmacokinetic, pharmacodynamic and safety profiles of HLX01(a rituximab biosimilar) and reference rituximab sourced from China(Mab Thera?;rituximab-CN).Methods: Here we report the results of two phase 1 studies. In the phase 1 a, open-label, dose-escalation study(NCT03218072, CTR20140400), eligible patients received 250, 375 and 500 mg/m^(2) HLX01 sequentially at 7-day intervals, after confirming no dose-limiting toxicity(DLT). In the phase 1 b, double-blind study(NCT02584920,CTR20140764), eligible patients were given a single dose of 375 mg/m^(2) HLX01 or rituximab-CN. The primary endpoints included safety and tolerability parameters for the phase 1 a and the area under the plasma concentrationtime curve from time zero to day 91(AUC0-91 d) for the phase 1 b study. Equivalence was concluded if 90%confidence interval(90% CI) for the geometric least squares mean ratio(GLSMR) fell in the pre-specified equivalence criteria(80%-125%).Results: Between June 20, 2014 and January 5, 2015, 12 patients were enrolled in the phase 1 a study. The pharmacokinetics of HLX01 showed dose proportionality and accumulation to steady state. HLX01 was well tolerated, with no serious adverse events(AEs), discontinuations or DLTs. Between November 8, 2014 and August13, 2015, 87 eligible patients were enrolled in the phase 1 b study, including 43 who received HLX01 and 44 who were treated with rituximab-CN. The equivalence endpoint was met with GLSMR for AUC0-91 d being 89.6%(90% CI: 80.4%-99.8%). AEs, anti-drug antibodies, and CD19+ and CD20+ B lymphocyte counts were similar between the HLX01 and rituximab-CN treatment ***: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell ***01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles.

关键词： Biosimilar lymphoma monoclonal antibody pharmacokinetics safety

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