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Neoadjuvant nivolumab with or without platinum-doublet chemotherapy based on PD-L1 expression in resectable NSCLC(CTONG1804):a multicenter open-label phase II study

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Signal Transduction and Targeted Therapy 2024年第1期9卷 249-258页

作者： Si-Yang Liu Song Dong Xue-Ning Yang Ri-Qiang Liao Ben-Yuan Jiang Qun Wang Xiao-Song Ben Gui-Bin Qiao Jun-Tao Lin Hong-Hong Yan Li-Xu Yan Qiang Nie Hai-Yan Tu Bin-Chao Wang Jin-Ji Yang Qing Zhou Hong-Rui Li Ke Liu Wendy Wu Si-Yang Maggie Liu Wen-Zhao Zhong Yi-Long Wu Guangdong Lung Cancer Institute Guangdong Provincial Key Laboratory of Translational Medicine in Lung CancerGuangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)Southern Medical UniversityGuangzhouChina Department of Thoracic Surgery Zhongshan HospitalFudan UniversityShanghaiChina Department of Thoracic Surgery Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)Southern Medical UniversityGuangzhouChina Department of Pathology Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)Southern Medical UniversityGuangzhouChina Fujian Key Laboratory of Advanced Technology for Cancer Screening and Early Diagnosis FuzhouChina Berry Oncology Corporation FuzhouChina Chinese Thoracic Oncology Group(CTONG) GuangzhouChina Department of Hematology The First Affiliated HospitalJinan UniversityGuangzhouChina

This prospective multicenter phase II study evaluated the clinical efficacy of neoadjuvant nivolumab-exclusive(N)and nivolumab–chemotherapy(N/C)combinations based on PD-L1 *** patients exhibited resectable clinical stage IIA–IIIB(AJCC 8th edition)NSCLC without EGFR/ALK *** received either mono-nivolumab(N)or nivolumab+nabpaclitaxel+carboplatin(N/C)for three cycles based on PD-L1 *** primary endpoint was the major pathological response(MPR).Key secondary endpoints included the pathologic complete response(pCR),objective response rate(ORR),and event-free survival(EFS).Baseline PD-L1 expression and perioperative circulating tumor DNA(ctDNA)status were correlated with pCR and ***-two patients were enrolled,with 46 undergoing *** MPR was 50.0%(26/52),with 25.0%(13/52)achieving pCR,and 16.7%and 66.7%for patients with PD-L1≥50%in N and N/C groups,***(25.0%)patients experienced grade 3 or higher immune-related adverse events during neoadjuvant *** with post-neoadjuvant ctDNA negativity was more likely to have pCR(39.1%)compared with those remained positive(6.7%,odds ratio=6.14,95%CI 0.84-Inf,p=0.077).With a median follow-up of 25.1 months,the 18-month EFS rate was 64.8%(95%CI 51.9–81.0%).For patients with ctDNA–***+,the 18m-EFS rate was 93.8%vs 47.3%(HR,0.15;95%CI 0.04,0.94;p=0.005).Immunochemotherapy may serve as an optimal neoadjuvant treatment even for patients with PD-L1 expression≥50%.ctDNA negativity following neoadjuvant treatment and surgery could help identify superior pathological and survival benefits,which requires further confirmation in a prospective clinical trial(NCT04015778).

关键词： chemotherapy NSCLC treatment

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液相色谱串联质谱法测定人血浆中奥马曲拉及其代谢物(英文)

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Acta Pharmacologica Sinica 2003年第1期24卷 76-86页

作者：王洪允胡玉芳江骥胡蓓中国医学科学院北京协和医院临床药理研究中心中国医学科学院北京协和医院临床药理研究中心北京 100730 中国

目的:建立液相色谱串联质谱法测定人血浆中奥马曲拉(BMS-186716)及其四种代谢物(BMS-196087,BMS-225308,BMS-198433和BMS-253653)。方法:以甲基丙烯酸酯对奥马曲拉、BMS-196087和BMS-253653结构中的游离巯基进行衍生化处理后,采用液相... 详细信息

目的:建立液相色谱串联质谱法测定人血浆中奥马曲拉(BMS-186716)及其四种代谢物(BMS-196087,BMS-225308,BMS-198433和BMS-253653)。方法:以甲基丙烯酸酯对奥马曲拉、BMS-196087和BMS-253653结构中的游离巯基进行衍生化处理后,采用液相进行测定。结果:奥马曲拉及其代谢物在下列范围内具有良好的线性关系:BMS-186716,0.2-250μg/L;BMS-196087,0.5-250μg/L;BMS-225308,1-250μg/L;BMS-198433,2-250μg/L;BMS-253653,10-2500μg/L。最低检测浓度分别为0.2μg/L、0.5μg/L、1.0μg/L、2.0μg/L和10μg/L;平均萃取回收率分别为60.5％、88.％、76.3％、71.2％、26.6％;日内精密度和日间精密度(RSD％)均在±15％之内,相对回收率在85％-115％之间;血浆样品可耐受3次冻融,室温下可稳定放置6小时,萃取后的样品室温下放置24小时没有任何异常变化,长期稳定性实验显示血浆样品在-30℃条件下可冻存3个月。结论:本方法准确、灵敏、快速、选择性好,能用于奥马曲拉及其代谢物的临床药代动力学研究。

关键词：奥马曲拉 BMS-186716 高效液相色谱质谱

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The role of latanoprost in an inflammatory bowel disease flare

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Gastroenterology Report 2014年第3期2卷 232-234页

作者： Sonali Paul Martin Wand Geoffrey T.Emerick James M.Richter Department of Gastroenterology and Hepatology Tufts Medical CenterBostonMAUSA Department of Ophthalmology University of Connecticut School of Medicine and Consulting OphthalmologistsFarmingtonCTUSA Department of Gastroenterology Massachusetts General HospitalBostonMAUSA

Ulcerative colitis and Crohn’s disease(CD)are characterized by inflammation of the intestinal mucosa and symptoms of abdominal pain and *** studies have shown an association between elevated levels of prostaglandins and mucosal damage in inflammatory bowel *** report a 50-year-old woman with a history of CD and open-angle *** glaucoma was treated with latanoprost,a prostaglandin analog,which was associated with an exacerbation of her *** discontinuation of latanoprost,her CD symptoms disappeared *** case suggests that in a patient with CD,topical administration of latanoprost may result in sufficient systemic absorption and circulation to promote a relapse of *** finding has important implications,not only for patients with inflammatory bowel disease and glaucoma,but also for both ophthalmologists and gastroenterologists.

关键词： lantanoprost Crohn’s disease prostaglandin glaucoma

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Covalently closed-circular hepatitis B virus DNA reduction with entecavir or lamivudine

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World Journal of Gastroenterology 2015年第15期21卷 4644-4651页

作者： Scott Bowden Stephen Locarnini Ting-Tsung Chang You-Chen Chao Kwang-Hyub Han Robert G Gish Robert A de Man Miao Yu Cyril Llamoso Hong Tang Victorian Infectious Diseases Reference Laboratory Division of Gastroenterology Department of Internal Medicine National Cheng Kung University Hospital Division of Gastroenterology Department of Internal Medicine Tri-Service General Hospital National Defense Medical Center Division of Gastroenterology Department of Internal Medicine Severance Hospital of Yonsei University Consultants LLC San Diego St Joseph’s Hospital and Medical Center Phoenix Hepatitis B Foundation Doylestown Department of Gastroenterology and Hepatology Room H375 Erasmus Medical Center bristol-myers squibb Research and Development 5 Research Pkwy Wallingford Center bristol-myers squibb Research and Development Princeton

AIM: To investigate the reduction in hepatitis B virus(HBV) covalently closed-circular DNA(ccc DNA) with entecavir(ETV) or lamivudine(LAM). METHODS: This analysis included patients who had participated in the randomized Phase Ⅲ study ETV-022 comparing ETV vs LAM in nucleos(t)ide-naive, HBe Agpositive patients. Patients received ETV(0.5 mg daily) or LAM(100 mg daily) for a minimum of 52 wk. Patients were eligible to participate in this sub-study if they had paired biopsies at baseline and week 48 with evaluable measurements for hepatic HBV ccc DNA and total hepatic HBV DNA. The main objective was to compare changes in hepatic HBV ccc DNA and total hepatic HBV DNA at week 48 of ETV or LAM treatment, which was a secondary endpoint of study ETV-022. Additional post hoc analyses included linear regression analyses to assess associations of baseline levels and on-treatment changes of ccc DNA with other baseline factors [sex,age, serum HBV DNA, alanine aminotransferase(ALT), Knodell necroinflammatory score, Ishak fibrosis score, total hepatic HBV DNA, and HBV genotype], or ontreatment factors(changes from baseline at week 48 in serum HBV DNA, ALT, Knodell necroinflammatory score, Ishak fibrosis score, total hepatic HBV DNA, and HBe Ag loss at week 48).RESULTS: Overall, 305 patients(ETV = 159; LAM = 146) of ETV-022 had paired baseline and week 48 liver biopsies with evaluable measurements for hepatic HBV ccc DNA and total hepatic HBV DNA, and were included in this analysis. Baseline demographics and disease characteristics were comparable between the two arms. After 48 wk, ETV resulted in significantly greater reductions in hepatic HBV ccc DNA [-0.9 log10 copies/human genome equivalent(HGEq) vs-0.7 log10 copies/HGEq; P = 0.0033] and total hepatic DNA levels(-2.1 log10 copies/HGEq vs-1.6 log10 copies/HGEq; P < 0.0001) than LAM. Virologic, biochemical, and histologic response rates at week 48 were also greater with ETV than with LAM. Baseline HBV ccc DNA levels were positivel

关键词： Hepatitis B virus Nucleos(t)ide analogtherapy Intrahepatic hepatitis B virus DNA Antiviralsuppression Virologic cure

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Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1

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World Journal of Gastroenterology 2016年第12期22卷 3418-3431页

作者： Ira Jacobson Stefan Zeuzem Robert Flisiak Brygida Knysz Stefan Lueth Dorota Zarebska-Michaluk Ewa Janczewska Peter Ferenci Moises Diago Anna Linda Zignego Rifaat Safadi Yaacov Baruch Dzhamal Abdurakhmanov Stephen Shafran Dominique Thabut Rafael Bruck Adrian Gadano Alexander James Thompson Justin Kopit Fiona Mc Phee Tracy Michener Eric A Hughes Philip D Yin Stephanie Noviello Weill Cornell Medical College New YorkNY 10029United States Icahn School of Medicine at Mount Sinai New YorkNY 10029United States JW Goethe University Hospital 60323 FrankfurtGermany Uniwersytet Medyczny w Bialymstoku 15-089 BialystokPoland EMC and Medical University 50-220 WroclawPoland Universitatsklinikum Hamburg-Eppendorf 20246 HamburgGermany Wojewodzki Szpital Zespolony w Kielcach 25-736 KielcePoland ID Clinic 41-400 MyslowicePoland Medizinische Universitat Wien 1090 ViennaAustria Clinica Quiron 46010 ValenciaSpain Universita degli Studi di Firenze 50121 FlorenceItaly Holy Family Hospital Nazareth 6004Israel Rambam Medical Center Haifa 31096Israel 1st Moscow State Medical University N.A.I.M.Sechenov 119991 MoscowRussia University of Alberta Hospital EdmontonAlberta T6G 2B7Canada Groupe Hospitalier Pitie-Salpetriere 75013 ParisFrance Tel Aviv Sourasky Medical Center and Tel Aviv University Tel Aviv 64239Israel Hospital Italiano de Buenos Aires Buenos Aires C1181ACHArgentina St.Vincents Hospital and the University of Melbourne Melbourne 3065Australia Fiona McPhee Bristol-Myers Squibb Research and DevelopmentWallingfordCT 06492United States bristol-myers squibb Research and Development PrincetonNJ 08450United States

AIM: To evaluate daclatasvir vs telaprevir, each combined with peginterferon alfa-2a/ribavirin(peg IFN/RBV), in treatment-naive hepatitis C virus(HCV) genotype(GT) 1-infected ***: In this phase 3, randomized, open-label, noninferiority study, 602 patients were randomly assigned(2:1) to daclatasvir vs telaprevir, stratified by IL28 B rs12979860 host genotype(CC vs non-CC), cirrhosis status(compensated cirrhosis vs no cirrhosis), and HCV GT1 subtype(GT1a vs GT1b). Patients were selected by study inclusion criteria from a total of 793 enrolled patients. Patients received daclatasvir 60 mg once daily or telaprevir 750 mg 3 times daily plus peg IFN/RBV. Daclatasvir recipients received 24 wk of daclatasvir plus peg IFN/RBV; those without an extended rapid virologic response(e RVR; undetectable HCV-RNA at weeks 4 and 12) received an additional 24 wk of peg IFN/RBV. Telaprevir-treated patients received 12 wk of telaprevir plus peg IFN/RBV followed by 12(with e RVR) or 36(no e RVR) wk of peg IFN/RBV. The primary objective was to compare for noninferiority of sustained virologic response rates at posttreatment week 12(SVR12) in GT1b-infected patients. Key secondary objectives were to demonstrate that the rates of anemia(hemoglobin < 10 g/d L) and rashrelated events, through week 12, were lower with daclatasvir + peg IFN/RBV than with telaprevir + peg IFN/RBV among GT1b-infected patients. Resistance testing was performed using population-based sequencing of the NS5 A region for all patients at baseline, and for patients with virologic failure or relapse and HCV-RNA ≥ 1000 IU/m L, to investigate any link between NS5 A polymorphisms associated with daclatasvir resistance and virologic outcome. RESULTS: Patient demographics and disease characteristics were generally balanced across treatment arms; however, there was a higher proportion of black/African Americans in the daclatasvir groups(6.0% and 8.2% in the GT1 b and GT1 a groups, respectively) than in the telaprevi

关键词： Direct-acting antiviral Chronic hepatitis C Daclatasvir Genotype 1b NS5A inhibitor Liver disease

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Opportunities and challenges in developing tissue-agnostic anti-cancer drugs

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Journal of Cancer Metastasis and Treatment 2020年第1期6卷 131-147页

作者： Ivan W.Li Nithya Krishnamurthy Ge Wei Gary Li Current affiliation:Canyon Crest Academy San DiegoCA 92130USA Current affiliation:Yale University New HavenCT 06520USA Translational Research IgnytaInc.San DiegoCA 92121USA Current affiliation:Translational Medicine QED TherapeuticsSan FranciscoCA 94107USA

The rapid advances in the understanding of oncogenic process and the maturation of affordable precision diagnostic tools have enabled the development of targeted therapeutic agents,such as those targeting BCR-ABL,epithelial growth factor receptor L858R,EML4-anaplastic lymphoma kinase,and BRAF V600E,to treat cancers that harbor specific molecular ***,each targeted drug has been developed for a particular tumor type where such alteration is most frequently ***,the widespread adoption of next generation sequencing has led to an increase in the identification of rare and ultra-rare alterations,and,in some cases,the same rare alterations are found across multiple tumor *** rarity of these alterations makes clinical trials traditionally designed for specific tumor types *** a result,tissue-agnostic trials have been developed to study the efficacy of these treatments and increase patient *** review summarizes current successful cases of tissue-agnostic development,such as drugs targeting tropomyosin receptor kinase fusions,and proposes the next wave of potential tissue-agnostic targets,including fusions of ROS1,anaplastic lymphoma kinase,fibroblast growth factor receptor,and rearranged during *** addition,the advantages and the challenges of such approach are discussed in the context of clinical development and approval.

关键词： Tissue agnostic basket trial tropomyosin receptor kinase anaplastic lymphoma kinase ROS1 fibroblast growth factor receptor rearranged during transfection

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Persistent Homology for the Quantitative Analysis of the Structure and Stability of Carboranes

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Chinese Journal of Structural Chemistry 2020年第6期39卷 999-1008页

作者： CHEN Dong ZHANG Ming-Zheng CHEN Hai-Biao XIE Zuo-Wei WEI Guo-Wei PAN Feng School of Advanced Materials Peking University Shenzhen Graduate School Shenzhen 518055China Department of Chemistry and State Key Laboratory of Synthetic Chemistry The Chinese University of HongKongShatinNew TerritoriesHong KongChina Department of Mathematics Michigan State UniversityMI 48824 USA Department of Electrical and Computer Engineering Michigan State UniversityMI 48824USA Department of Biochemistry and Molecular Biology Michigan State UniversityMl 48824USA

Persistent homology is a powerful and novel tool for quantifying the inherent topological features of structure. In this work, we used the persistent homology for the first time to study the closo-carboranes C2Bn-2Hn(n = 5~20) and their parent structures closo-boranes dianions BnHn2-(n = 5~20), where multiple elements are present. All these structures are first investigated with the standard Vitoris-Rips complex. We interpret all barcodes representation and associate them with structural details. By means of average bar length, a linear regression model was established to construct the relationship between persistent homology features and molecular stability, which was expressed by the relative energies. For closo-boranes dianions, we only use B atom set since B and H atoms are in pairs. The average lengths of β0, β1 and β2 bars are used as the features for linear regression, and excellent correlation coefficient(0.977) between the values predicted by persistent homology and those by quantum calculations was achieved. For closo-carboranes, C–B atom set(ignore the differences in the atoms), B atom set and C atom set were considered to get the persistent homology features(since there were only two C atoms in C2Bn-2Hn, only β0 bars were considered), and seven average bar lengths were calculated, respectively. Pearson coefficient of 0.937 was obtained. We found that the stability of carboranes showed a high linear correlation with the characteristics generated from topological bars in H0, H1 and H2. The results show that the topological information generated by persistent homology can be extended and applied to multi-element systems.

关键词： topology persistent homology carboranes filtration stability relative energy

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Treating chronic hepatitis B virus:Chinese physicians' awareness of the 2010 guidelines

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World Journal of Hepatology 2016年第18期8卷 762-769页

作者： Lai Wei Ji-Dong Jia Xin-Hua Weng Xiao-Guang Dou Jia-Ji Jiang Hong Tang Qin Ning Qing-Qing Dai Run-Qin Li Jie Liu Department of Hepatology Peking University People’s Hospital Department of Hepatology Beijing Friendship HospitalCapital Medical University Department of Infectious Disease Shanghai Huashan Hospital Department of Infectious Disease Shengjing Hospital of China Medical University Department of Hepatology the First Affiliate Hospital of Fujian Medical University Department of Infectious Disease West China HospitalSichuan University Department of Infectious Disease Affiliated Tongji Hospital of Tongji Medical College bristol-myers squibb

AIM: To investigate Chinese physicians' awareness of the 2010 guidelines on the treatment of chronic hepatitis B virus(HBV) ***: This was a quantitative survey that investigated the characteristics and practices of physicians who were treating patients with hepatitis B, the profile of their patients and physician practices regarding the diagnosis and treatment of HBV at the time of the survey. Participants were randomly selected from available databases of Chinese physicians and requested to complete either an online or paper-based survey. Data from the survey responses were analysed. For data validation and interpretation, qualitative in-depth interviews were conducted with 39 of the ***: Five-hundred completed surveys, from 663 physicians were available for analysis. A mean of 175 chronic hepatitis B(CHB) patients was seen by each physician every month, of whom 85(49%) were treated in line with therapeutic indications stated in the 2010 guidelines. A total of 444(89%) physicians often(> 60% of the time) adhered to the guidelines. Most physicians used antiviral medications as recommended. For patients with compensated and decompensated cirrhosis, 342(68%) and 336(67%) of physicians, respectively, often followed the recommendation to use potent nucleos(t)ide analogues with a high genetic barrier to resistance, using the appropriate treatment more than 60% of the time. Physicians from infectious disease or liver disease departments were better informed than those from gastrointestinal or other ***: The majority of Chinese physicians often adhere to Chinese 2010 CHB guidelines and are well-informed about the use of antiviral medications for hepatitis B.

关键词： Chronic hepatitis B Practice guidelines Awareness China Physicians

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Risk calculators for hepatocellular carcinoma in patients affected with chronic hepatitis B in Asia

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World Journal of Gastroenterology 2014年第20期20卷 6244-6251页

作者： Hwai-I Yang Mei-Hsuan Lee Jessica Liu Chien-Jen Chen Genomics Research Center Academia Sinica Graduate Institute of Clinical Medical Science China Medical University Taichung Molecular and Genomic Epidemiology Center China Medical University Hospital Institute of Clinical Medicine National Yang Ming University Graduate Institute of Epidemiology and Preventive Medicine College of Public Health National TaiwanUniversity

Risk calculators are widely used in many clinical fields, and integrate several important risk factors through the conversion of a risk function into a single measure of risk. Several studies have been carried out to create risk calculators for the prediction of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). Most of them were hospital-based, with limited sample sizes and insufficient external validation. These study groups collaborated to establish the REACH-B risk score, which incorporated five clinical variables to predict HCC risk. This risk score was then validated in international clinical cohorts. Evidence suggests that quantitative serum HBsAg level provides additional predictability of HCC, especially in patients with low levels of hepatitis B virus DNA. This novel marker was incorporated into a risk calculator and was internally validated. This tool will hopefully be externally validated in the near future. Risk calculators can be used to support clinical practice, and to establish preventive measures; several “off-label” extension usages have also been implemented. Albeit beneficial, several precautions and discussions should be noted in using the risk calculators. The future development of risk calculators for CHB patients can be extended by applying them to additional CHB-related outcomes, and by incorporating emerging risk parameters.

关键词： Chronic hepatitis B Hepatocellular carcinoma Risk calculator Hepatitis B virus

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P-glycoprotein regulating biphasic insulin secretion in rat pancreatic beta cells

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Chinese Medical Journal 2009年第21期122卷 2587-2592页

作者： TANG Yun-zhao LI Dai-qing SUN Fu-jun LI Li YU De-min Key Lab of Hormone and Development (Tianjin and Ministry of Health of the People's Republic of China) Institution of Endociinology Tianjin Metabolic Diseases Hospital Tianjin Medical University Tianjin 300070 China

Background A 65-kD mdrl （multi-drug resistance protein 1, P-glycoprotein）-Iike protein has been suggested to be the regulatory protein to the chloride channel protein 3 （CIC-3） mediating insulin granules acidification and release in mouse pancreatic beta cells. But the protein has not been deeply investigated. In this study, we identified existence of the 65-kda protein in rat islets and preliminarily explored its biological functions. Methods Total RNAs of rat kidneys served as positive controls, and pancreas, islets and INS-1 cells were extracted for reverse-transcript PCR （RT-PCR）, respectively. The cDNAs were run with specific primers selected from the mRNA of abcblb encoding P-glycoprotein. All PCR products were visualized in agarose gel electrophoresis and sequenced. Homogenates of rat islets and INS-1 cells were applied to SDS-PAGE. P-glycoprotein was detected by a specific monoclonal antibody, C219. Biphasic insulin release was measured in static incubations of rat islets with radioimmunology assay. Results Compared with positive control, expression of the P-glycoprotein mRNA segments were detected in the islets, INS-1 cells and pancreas. Sequence analysis confirmed that the PCR products were matched with mRNA of P-glycoprotein. A 65-kda protein was recognized by the antibody in the islets homogenate but not in that of INS-1 cells in Western-blotting. Instead, the homogenate of INS-1 cells contained a 160-kda protein recognized by the antibody. Insulin secretion of rat islets were stimulated by high glucose （16.7mmol/L）, and showed biphasic curve during 60-minute incubation. After co-incubation with cyclosporine A （CsA）, specific inhibitor to P-glycoprotein, the second phase of insulin secretion was reduced significantly while the first phase was not influenced. Conclusions The 65-kda protein expressed in rat islets is most likely a mini-P-glycoprotein. It may play a key role regulating biphasic insulin release.

关键词： pancreatic beta cell islet P-glycoprotein biphasic insulin secretion

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