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Science China(Life Sciences) 2025年第1期68卷 249-262页

作者： Jinliang Wang Wenyong Zhou Yu Xu Jianchun Duan Qiaoxia Zhou Guoqiang Wang Leo Li Chunwei Xu Wenxian Wang Shangli Cai Zhijie Wang Jie Wang Department of Oncology The Fifth Medical Center of Chinese PLA General HospitalBeijing 100091China Department of Thoracic Surgery Shanghai Chest HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200025China Burning Rock Biotech Guangzhou 510300China CAMS Key Laboratoryof Translational Research on LungCancer State Key Laboratoryof Molecular OncologyDepartmentof Medical OncologyNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Institute of Basic Medicine and Cancer(IBMC) Chinese Academy of SciencesHangzhou 310000China Department of Clinical Trial The Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)Hangzhou 310022China

In non-small cell lung cancers,the non-squamous and squamous subtypes(nsqNSCLC and sqNSCLC)exhibit disparities in pathophysiology,tumor immunology,and potential genomic correlates affecting responses to immune checkpoint inhibitor(ICI)-based *** our inhouse training cohort(n=85),the presence of the LRP1B deleterious mutation(LRP1B-del)was associated with longer and shorter progression-free survival(PFS)on ICIs alone in nsqNSCLCs and sqNSCLCs,respectively(Pinteraction=0.008).These results were validated using a larger public ICI cohort(n=208,Pinteractionbiomarkers for cancer therapeutics.

关键词： non-squamous NSCLC squamous NSCLC LRP1B deleterious mutations predictive biomarker immune checkpoint inhibitor

An integrative approach of digital image analysis and transcriptome profiling to explore potential predictive biomarkers for TGFβblockade therapy

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Acta Pharmaceutica Sinica B 2022年第9期12卷 3594-3601页

作者： Robert Pomponio Qi Tang Anthony Mei Anne Caron Bema Coulibaly Joachim Theilhaber Maximilian Rogers-Grazado Michele Sanicola-Nadel Souad Naimi Reza Olfati-Saber Cecile Combeau Jack Pollard Tun Tun Lin Rui Wang Sanofi Translational Medicine Early Development Cambridge MA 02142USA Sanofi Artificial Intelligence and Deep Analytics Data and Data Sciences CambridgeMA 02142USA Sanofi Translational Science Vitry sur Seine 94403France Sanofi Precision Oncology Cambridge MA 02142USA Sanofi Oncology Early Development Cambridge MA 02142USA

Increasing evidence suggests that the presence and spatial localization and distribution pattern of tumor infiltrating lymphocytes(TILs)is associate with response to *** studies have identified TGFβactivity and signaling as a determinant of T cell exclusion in the tumor microenvironment and poor response to PD-1/PD-L1 *** we coupled the artificial intelligence(AI)-powered digital image analysis and gene expression profiling as an integrative approach to quantify distribution of TILs and characterize the associated TGFβpathway *** of T cell spatial distribution in the solid tumor biopsies revealed substantial differences in the distribution *** digital image analysis approach achieves 74%concordance with the pathologist assessment for tumor-immune *** transcriptomic profiling suggests that the TIL score was negatively correlated with TGFβpathway activation,together with elevated TGFβsignaling activity observed in excluded and desert tumor *** present results demonstrate that the automated digital pathology algorithm for quantitative analysis of CD8 immunohistochemistry image can successfully assign the tumor into one of three infiltration phenotypes:immune desert,immune excluded or immune *** association between“cold”tumor-immune phenotypes and TGFβsignature further demonstrates their potential as predictive biomarkers to identify appropriate patients that may benefit from TGFβblockade.

关键词： Digital pathology Artificial intelligence TGFβ predictive biomarker Tumor topography T cell infiltration Transcriptomic profiling Machine learning

BATE curve in assessment of clinical utility of predictive biomarkers

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Science China Mathematics 2012年第8期55卷 1529-1552页

作者： ZHOU XiaoHua 1,2,3,& MA YunBei 4,5 1 Northwest HSR&D Center of Excellence,VA Puget Sound Health Care System,Seattle,WA 98198,USA 2 Department of Biostatistics,University of Washington,Seattle,WA 98198,USA 3 Beijing International Center for Mathematical Research,Peking University,Beijing 100871,China 4 Department of Operations Research and Financial Engineering,Princeton University,Princeton,NJ 08540,USA 5 School of Statisitcs,Southwest University of Finance and Economics,Chengdu 611130,China 1. Northwest HSR&D Center of Excellence VA Puget Sound Health Care System Seattle WA 98198 USA2. Department of Biostatistics University of Washington Seattle WA 98198 USA3. Beijing International Center for Mathematical Research Peking University Beijing 100871 China4. Department of Operations Research and Financial Engineering Princeton University Princeton NJ 08540 USA5. School of Statisitcs Southwest University of Finance and Economics Chengdu 611130 China

In this paper, for time-to-event data, we propose a new statistical framework for casual inference in evaluating clinical utility of predictive biomarkers and in selecting an optimal treatment for a particular patient. This new casual framework is based on a new concept, called biomarker Adjusted Treatment Effect （BATE） curve. The BATE curve can be used for assessing clinical utility of a predictive biomarker, for designing a subsequent confirmation trial, and for guiding clinical practice. We then propose semi-p^rametric methods for estimating the BATE curves of biomarkers and establish asymptotic results of the proposed estimators for the BATE curves. We also conduct extensive simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrate the application of the proposed method in a real-world data set.

关键词： predictive biomarker cutoff points interaction BATE curve time-to-event outcome

The cutting-edge progress of immune-checkpoint blockade in lung cancer

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Cellular & Molecular Immunology 2021年第2期18卷 279-293页

作者： Fei Zhou Meng Qiao Caicun Zhou Department of Medical Oncology Shanghai Pulmonary HospitalThoracic Cancer InstituteTongji University School of MedicineShanghaiChina

Great advances in immune checkpoint blockade have resulted in a paradigm shift in patients with lung ***-checkpoint inhibitor(ICI)treatment,either as monotherapy or combination therapy,has been established as the standard of care for patients with locally advanced/metastatic non-small cell lung cancer without EGFR/ALK alterations or extensive-stage small cell lung *** increasing number of clinical trials are also ongoing to further investigate the role of ICIs in patients with early-stage lung cancer as neoadjuvant or adjuvant *** PD-L1 expression and tumor mutational burden have been widely studied for patient selection,both of these biomarkers are *** to the complex cancer-immune interactions among tumor cells,the tumor microenvironment and host immunity,collaborative efforts are needed to establish a multidimensional immunogram to integrate complementary predictive biomarkers for personalized ***,as a result of the wide use of ICIs,managing acquired resistance to ICI treatment remains an inevitable challenge.A deeper understanding of the underlying biological mechanisms of acquired resistance to ICIs is helpful to overcome these *** this review,we describe the cutting-edge progress made in patients with lung cancer,the optimal duration of ICI treatment,ICIs in some special populations,the unique response patterns during ICI treatment,the emerging predictive biomarkers,and our understanding of primary and acquired resistance mechanisms to ICI treatment.

关键词： lung cancer immune-checkpoint inhibitor predictive biomarker acquired resistance

Potential new applications of immunotherapy for neuroendocrine neoplasms:immune landscape,current status and future perspectives

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Cancer Biology & Medicine 2022年第12期19卷 1649-1661页

作者： Rilan Bai Wenqian Li Jiuwei Cui Cancer Center the First Hospital of Jilin UniversityChangchun 130021China

Neuroendocrine neoplasms(NENs)are a highly heterogeneous class of tumors arising from neuroendocrine cells and peptidergic *** failure of first-line treatment,patients have poor prognosis and limited treatment *** checkpoint inhibitors(ICIs)may be a powerful means of increasing therapeutic efficacy for such patients,but ICIs alone have low response rates and short disease control durations in most NENs and may be effective for only a portion of the *** combined with other immunotherapies,targeted therapies,or cytotoxic drugs have achieved some efficacy in patients with NENs and are worthy of further exploration to assess their benefits to the *** addition,accumulating experimental and clinical evidence supports that the interaction between neuroendocrine and immune systems is essential to maintain homeostasis,and assessment of this broad neuroendocrine-immune correlation is essential for NEN *** this review,we summarize the immune microenvironment characteristics,advances in immunotherapy,predictive biomarkers of ICI efficacy for NENs,and the effects of common endocrine hormones on the immune system,highlighting possible new application areas for this promising treatment in neglected NENs.

关键词： Neuroendocrine neoplasms immunotherapy predictive biomarker hormones

Long survival after immunotherapy plus paclitaxel in advanced intrahepatic cholangiocarcinoma: A case report and review of literature

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World Journal of Clinical Cases 2022年第32期10卷 11889-11897页

作者： Meng-Ye He Fei-Fei Yan Kai-Li Cen Peng Shen Department of Medical Oncology First Affiliated HospitalZhejiang University School of MedicineHangzhou 310000Zhejiang ProvinceChina

BACKGROUND Intrahepatic cholangiocarcinoma(iCCA)is the second most common primary hepatic malignancy ***,currently available systemic therapies are of limited effectiveness,and the median overall survival of patients treated with first-line standard chemotherapy is less than one *** checkpoint inhibitors have been used to treat solid *** studies recently explored the combination of chemotherapy and immunotherapy for ***,the clinical significance of predictive biomarkers for chemo-immunotherapy in CCA remains *** is also worth exploring whether a combination of chemotherapeutic agents can increase the sensitivity of CCA *** SUMMARY This study reports a case of advanced iCCA in which clinical complete remission had been achieved using a programmed death 1(PD-1)inhibitor and paclitaxel without known predictive biomarkers,but with BRCA1,KRAS,and NTRK3 mutations after rapid progression to first-line chemotherapy,and has remained in clinical complete remission for more than two *** case suggests that chemo-immunotherapy is a potential therapeutic option for patients with iCCA and few known predictive biomarkers for immunotherapies as well as synergistic effect of the combination of paclitaxel and PD-1 monoclonal *** The combination of paclitaxel and PD-1 monoclonal antibodyr can be explored in patients with advanced iCCA.

关键词： Intrahepatic cholangiocarcinoma Programmed cell death protein-1 inhibitor Paclitaxel Chemo-immunotherapy predictive biomarker Case report

Immunotherapy in gastric cancer

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World Journal of Gastroenterology 2014年第7期20卷 1657-1666页

作者： Satoko Matsueda David Y Graham Cancer Vaccine Development Division Research Center for Innovative Cancer TherapyKurume UniversityKurumeFukuoka 830-0011Japan Michael E DeBakey VA Medical Center Baylor College of MedicineHoustonTX 77030United States

Gastric cancer is the second most common of cancerrelated deaths *** the majority of cases gastric cancer is advanced at diagnosis and although medical and surgical treatments have improved,survival rates remain *** immunotherapy has emerged as a powerful and promising clinical approach for treatment of cancer and has shown major success in breast cancer,prostate cancer and ***,we provide an overview of concepts of modern cancer immunotherapy including the theory,current approaches,remaining hurdles to be overcome,and the future prospect of cancer immunotherapy in the treatment of gastric *** cell therapies,cancer vaccines,gene therapies,monoclonal antibody therapies have all been used with some initial successes in gastric ***,to date the results in gastric cancer have been disappointing as current approaches often do not stimulate immunity efficiently allowing tumors continue to grow despite the presence of a measurable immune ***,we discuss the identification of targets for immunotherapy and the role of biomarkers in prospectively identifying appropriate subjects or *** also discuss the molecular mechanisms by which tumor cells escape host immunosurveillance and produce an immunosuppressive tumor *** show how advances have provided tools for overcoming the mechanisms of immunosuppression including the use of monoclonal antibodies to block negative regulators normally expressed on the surface of T cells which limit activation and proliferation of cytotoxic T *** has greatly improved and is becoming an important factor in such fields as medical care and welfare for human *** has been rapid ensuring that the future of immunotherapy for gastric cancer is bright.

关键词： Gastric cancer Immune checkpoint Immune escape Adoptive cell therapy Cancer vaccine Antibody therapy predictive biomarker

Resistance to antibody-drug conjugates in breast cancer:mechanisms and solutions

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Cancer Communications 2023年第3期43卷 297-337页

作者： Yu-Fei Chen Ying-ying Xu Zhi-Ming Shao Ke-Da Yu Department of Breast Surgery Fudan University Shanghai Cancer CenterShanghai 200032P.R.China Shanghai Medical College Fudan UniversityShanghai 200032P.R.China Department of Breast Surgery First Affiliated Hospital of China Medical UniversityShenyangLiaoning 110001P.R.China

Antibody-drug conjugates(ADCs)are a rapidly developing therapeutic approach in cancer treatment that has shown remarkable activity in breast ***,there are two ADCs approved for the treatment of human epidermal growth factor receptor 2-positive breast cancer,one for triple-negative breast cancer,and multiple investigational ADCs in clinical ***,drug resistance has been noticed in clinical use,especially in trastuzumab ***,the mechanisms of ADC resistance are summarized into four categories:antibodymediated resistance,impaired drug trafficking,disrupted lysosomal function,and payload-related *** overcome or prevent resistance to ADCs,innovative development strategies and combination therapy options are being *** predictive biomarkers for optimal therapy selection may also help to prevent drug resistance.

关键词： Antibody-drug conjugate breast cancer drug resistance combination therapy predictive biomarker

Refractory case of ulcerative colitis with idiopathic thrombocytopenic purpura successfully treated by Janus kinase inhibitor tofacitinib:A case report

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World Journal of Clinical Cases 2020年第24期8卷 6389-6395页

作者： Yoriaki Komeda Toshiharu Sakurai Arito Hashimoto Tomoyuki Nagai Satoru Hagiwara Masatoshi Kudo Kazuko Sakai Kazuto Nishio Yasuyoshi Morita Itaru Matsumura Department of Gastroenterology and Hepatology Kindai University Faculty of MedicineOsaka 589-8511Japan Department of Genome Biology Kindai University Faculty of MedicineOsaka 589-8511Japan Department of Hematology and Rheumatology Kindai University Faculty of MedicineOsaka 589-8511Japan

BACKGROUND Concomitant ulcerative colitis (UC) and idiopathic thrombocytopenic purpura(ITP) is a rare phenomenon. The management of UC with ITP can be challenging,since a decreased platelet count augments *** SUMMARY A 24-year-old man with UC and steroid-resistant ITP experienced UC *** continuous infusion of cyclosporine was initiated, UC did not *** administration of tofacitinib subsequently led to the induction of *** patient has maintained remission of UC and ITP for over one year ontofacitinib treatment. Whole transcriptomic sequencing was performed forinflamed rectal mucosae obtained before and after the initiation of Janus kinase(JAK) inhibitor, suggesting that distinct molecular signatures seemed to beregulated by JAK inhibitors and other conventional therapies including tumornecrosis factor *** Tofacitinib should be considered in refractory cases of UC with ITP.

关键词： Ulcerative colitis Idiopathic thrombocytopenic purpura Tofacitinib Whole transcriptome analysis Case report predictive biomarker

Individualized therapy for metastatic renal cell carcinoma

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Journal of Cancer Metastasis and Treatment 2021年第1期7卷 672-685页

作者： Bambang T.Atmaja Izabelle Wood Suyanto Suyanto Paramvir Sawhney Agnieszka Michael Hardev Pandha St Luke’s Cancer Centre Royal Surrey County HospitalGuildford GU27XXUK Department of Oncology University College London Cancer InstituteLondon WC1E 6DDUK.

Metastatic Renal Cell Carcinoma(mRCC)is a highly heterogeneous disease that is notoriously difficult to treat ***,the discovery of novel,targeted therapies over the last decade has revolutionized its *** the therapeutic options continue to evolve,developing a more individualized treatment strategy is of paramount *** International mRCC Database Consortium(IMDC)is a prognostic model that is commonly used in trials and clinical settings to risk stratify *** allows for optimal therapy selection on a more individual ***,the distinct lack of validated predictive biomarkers in mRCC renders it difficult to assess therapy *** improved understanding of tumor biology and genetics has prompted a shift from cytokine therapy to the use of vascular endothelial growth factor(VEGF)inhibitors,tyrosine kinase Inhibitors,immune checkpoint inhibitors or combination *** have identified some putative markers and genetic mutations as potential predictors of therapy *** results are promising,and there are many ongoing trials further assessing their suitability for clinical *** review will evaluate the current treatment landscape and molecular biology of mRCC,with a specific focus on the prognostic and predictive markers available to guide treatment options and further improve patient outcomes.

关键词： Metastatic renal cell carcinoma IMDC predictive biomarker individualized therapy immunotherapy VEGF prognosis