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Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial

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Cancer Biology & Medicine 2021年第3期18卷 816-824页

作者： Tianqing Chu Jun Lu Minghong Bi Helong Zhang Wu Zhuang Yan Yu Jianhua Shi Zhendong Chen Xiaochun Zhang Qisen Guo Quan Liu Huijuan Wu Jian Fang Yi Hu Xiuwen Wang Cuicui Han Kai Li Baohui Han Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversitySha nghai 200030China Department of oncology The First Affiliated Hospital of Bengbu Medical CollegeBengbu 233004China Department of oncology Tangdu HospitalAir Force Medical University of PLAXi'an 710038China Department of Medical thoracic oncology Fujian Cancer HospitalFujian Medical University Cancer HospitalFuzhou 350014China Department of oncology Harbin Medical University Cancer HospitalHarbin 150081China Department of oncology Linyi Cancer HospitalLinyi 276000China Department of oncology The Second Hospital of Anhui Medical UniversityHefei 230601China Department of oncology The Affiliated Hospital of Qingdao UniversityQingdao 266071China Department of Internal Medicine Shandong Cancer Hospital Affiliated to Shandong UniversityJinan 250117China Department of oncology Affiliated Hospital of Jiang Nan UniversityWuxi 214122China Department of Internal Medicine Henan Province Tumor HospitalZhengzhou UniversityZhengzhou 450008China Department of thoracic oncologyⅡ Peking University Cancer Hospital and InstituteBeijing 100142China Department of oncology Chinese PLA General HospitalBeijing 100039China Department of oncology Qilu Hospital of Shandong UniversityJinan 250012China Department of Clinical Research Centre Qilu Pharmaceutical Co.LtdJinan 250101China Department of thoracic 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

Objective:This phase 3 study aimed to test equivalence in efficacy and safety for QL1101,a bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous non-small cell lung cancer(NSCLC).Methods:Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101 or bevacizumab,15 mg/kg every 3-week for 6 *** was followed by maintenance treatment with single agent QL1101 every *** primary end-point was objective response rate(ORR),with secondary end-points being progression-free survival(PFS),overall survival(OS),disease control rate(DCR),and adverse events(AEs).Results:Of 675 patients,535 eligible patients were randomized to the QL1101 group(n=269)and bevacizumab group(n=266).ORRs were 52.8%and 56.8%,respectively,for the QL1101 and bevacizumab groups,with an ORR hazard ratio 0.93(95%confidence interval:0.8-0131.1).The PFS,OS,DCR,and AEs were comparable between the 2 groups,which remained the same after stratification according to epidermal growth factor receptor mutation or smoking ***:QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC.

关键词： Biosimilar bevacizumab equivalence non-squamous NSCLC clinical efficacy

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ANTITUMOR AQCTIVITY OF REGIONAL ADMINISTRATION OF A-NK CELLS IN VIVO

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Chinese Journal of Cancer Research 2006年第4期18卷 290-293页

作者：高君王志华张志斌杨虹 institute of oncology Harbin Medical University

Objective： To observe the proliferation of A-NK in vitro and antitumor activity in vivo. Methods： The growth curve of A-NK and NA-NK cells was drawn in vitro. In the rat model, we compared the regional administration of A-NK-/IL-2 with the systemic administration. Results： The expansion of A-NK cells reached to climax on day 10 in the culture, increased 16.08 folds compared with the only 3.36 folds for NA-NK cells. In the rat model, we found that the regional administration of A-NK/IL-2 was better than systemic administration or administration of NA-NK/IL-2 not only in tumor infiltration and antitumor response, but also in the survival rate of rats （P〈0.05）. Conclusion： A-NK cells is a new immune effecter cells with high expansibility and high antitumor activity in vivo and in vitro.

关键词： A-NK NA-NK Proliferation Antitumor

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Functional studies of a novel oncogene TGM3 in human esophageal squamous cell carcinoma

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World Journal of Gastroenterology 2006年第24期12卷 3929-3932页

作者： Wei Liu Zai-Cheng Yu Wen-Feng Cao Fang Ding Zhi-Hua Liu Department of thoracic Surgery the First Affiliated Hospital of Anhui Medical University Hefei 230022 Anhui Province China National Laboratoryof Molecular oncology Cancer Institute Chinese Academy of Medical Science and Peking Union Medical College Beijing 100021 China

AIM： To investigate the role of transglutaminase 3 （TGM3） gene in human esophageal squamous cell carcinoma （ESCC）, and analyze its relationship with clinicopathological parameters. METHODS： Gene expression of TGM3 in fresh esophageal cancer tissues and their corresponding normal mucosas was detected immunohistochemically（I HC） by means of tissue microarray（TMA）. Its correlation with clinical characteristics was evaluated and analyzed by univariate analysis. All statistical analyses were performed by SPSS version 10.0. RESULTS： Expression rate of TGM3 was reduced to 81.8% in ESCC. Expression of TGM3 was significantly inversely correlated with histological grade of esophageal carcinoma （in grade I, II and III tumors, the reduced expression was 4/7, 57/71, and 20/21, respectively, P 〈 0.05）, whereas it had no obvious correlations with lymph node metastasis and depth of invasion. CONCLUSION： Reduced expression of TGM3 may play an important role in esophageal carcinogenesis.

关键词： Esophageal squamous cell carcinoma Immunohistochemically, Tissue microarray

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ANTITUMOR IMMUNITY AND VACCINE EFFECT INDUCED BY IL-12 SYNERGIZES B7-1 GENE TRANSFECTED CELLS

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Chinese Journal of Cancer Research 2003年第1期15卷 5-8页

作者：王志华李弘张春艳 institute of oncology Harbin Medical University

Objective: To study the synergic effects of IL-12 and B7-1 transfectant on antitumor immunity in vivo. Methods: The retrovirus vector encoding mIL-12 and mB7-1 gene was tranfected into EL-4 thymic lymphoma cells *** cells were used as tumor vaccine and the therapeutic effect was observed. Results: In contrast to the miceimmunized with EL-4/Wt or EL-4/Neo groups, thetumorigenicity of EL-4/IL-12 transfectant was decreased(P<0.001). The EL-4/IL-12 and EL-4/B7-1 cells irradiatedwith 60Co showed significant systematic protective effectsagainst the rechallenge of EL-4/Wt. 60Co irradiatedEL-4/IL-12 cells delayed the occurrence of tumor andprolonged the survival period of tumor bearing *** of the vaccines of EL-4/IL-12 and EL-4/B7-1 resulted in the enhanced therapeutic effect compared witheach single transfectant group (P<0.001). Conclusion: The results showed that IL-12 transduced cells could enhancethe antitumor immunity of host as cancer *** of the EL-4/IL-12 and EL-4/B7-1 transfectant could improve immunity of host and is a prospect cancervaccine.

关键词： IL-12 B7-1 Tumor immunity Cancer vaccine

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The role of epigenetic inactivation of 14-3-3σ in human cancer

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Cell Research 2005年第4期15卷 237-246页

作者： Dmitri LODYGIN, Heiko HERMEKING Molecular oncology Max-Planck institute of Biochemistry Am Klopferspitz 18 Martinsried/Munich Germany Molecular oncology Max-Planck institute of Biochemistry Am Klopferspitz 18 Martinsried/Munich Germany

Cancer cells show characteristic alterations in DNA methylation patterns. Aberrant CpG methylation of specificpromoters results in inactivation of tumor suppressor genes and therefore plays an important role in carcinogenesis. Thep53-regulated gene 14-3-3σ undergoes frequent epigenetic silencing in several types of cancer, including carcinoma ofthe breast, prostate, and skin, suggesting that the loss of 14-3-3σ expression may be causally involved in tumor *** studies demonstrated that 14-3-3σ is involved in cell-cycle control and prevents the accumulation of chro-mosomal damage. The recent identification of novel 14-3-3σ-associated proteins by a targeted proteomics approachimplies that 14-3-3σ regulates diverse cellular processes, which may become deregulated after silencing of 14-3-3σexpression in cancer cells.

关键词： 14-3-3σ CpG methylation p53 epigenetic silencing cancer cell cycle.

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Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer patients:A two-year follow-up data update

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Chinese Journal of Cancer Research 2022年第1期34卷 28-39页

作者： Jun Lu Tianqing Chu Hongyu Liu Minjuan Hu Yuqing Lou Yanwei Zhang Zhiqiang Gao Wei Zhang Xueyan Zhang Huimin Wang Hua Zhong Baohui Han Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Shanghai institute of thoracic oncology Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Translational Medical Research Platform for thoracic oncology Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Department of Bio-bank Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China

Objective: Anti-vascular endothelial growth factor(VEGF) monoclonal antibodies are an effective means of treating non-small cell lung cancer(NSCLC). Here, we aim to update the equivalent efficacy assessment between QL1101 and bevacizumab based on two-year follow-up ***: In total, 535 eligible NSCLC patients were enrolled in this randomized controlled trial. Patients were randomly assigned 1:1 to the QL1101 group and the bevacizumab group. The full end time of this study was defined as 24 months after the last enrolled patient was randomized. The primary endpoint was the objective response rate(ORR);equivalence was confirmed if the two-sided 90% confidence interval(90% CI) of the relative risk was within the range of 0.75-1.33. The secondary endpoints were progression-free survival(PFS) and overall survival(OS).Results: The two-year updated data showed similar ORR(QL1101 vs. bevacizumab: 53.1% vs. 54.3%;relative risk=0.977;90% CI: 0.838-1.144), PFS(235 d vs. 254 d, log-rank P=0.311), and OS(577 d vs. 641 d, log-rank P=0.099) results between the QL1101 group and the bevacizumab group. The mean shrinkage ratio of targeted lesions was also similar between the QL1101 group and the bevacizumab group(22.5% vs. 23.5%). For patients who received QL1101 maintenance therapy, similar results were shown between the QL1101 group(n=157) and the bevacizumab group(n=148)(PFS: 253 d vs. 272 d, log-rank P=0.387;OS: 673 d vs. 790 d, log-rank P=0.101;mean tumor shrinkage rate: 26.6% vs. 27.5%).Conclusions: This study reported that QL1101 had similar efficacy in treating nonsquamous NSCLC in terms of ORR, PFS and OS based on two-year updated data, providing a basis for the clinical application of QL1101.

关键词： QL1101 biosimilar non-small cell lung cancer bevacizumab VEGF

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Treatment of hemorrhagic radiation-induced proctopathy with a 4% formalin application under perianal anesthetic infiltration

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World Journal of Gastroenterology 2013年第30期19卷 4944-4949页

作者： Narimantas Evaldas Samalavicius Audrius Dulskas Alfredas Kilius Kestutis Petrulis Darius Norkus Arvydas Burneckis Konstantinas Povilas Valuckas Center of Oncosurgery Institute of OncologyClinic of Internal DiseasesFamily Medicine and Oncology of Medical FacultyVilnius UniversityLT-08406VilniusLithuania Center of Oncosurgery Institute of OncologyVilnius UniversityLT-08406VilniusLithuania Radiotherapy and Drug Therapy Center Institute of OncologyVilnius UniversityLT-08406VilniusLithuania

AIM:To evaluate the results of hemorrhagic radiation proctopathy treatment with a 4% formalin ***:A prospective study was *** a three-year period,38 patients underwent 4% formalin application under perianal anesthetic infiltration for hemorrhagic radiation *** patients included in the study were irradiated for prostate *** patients ranged in age from 56-77 years(average 70 ± 5 years).All of the patients were referred for formalin therapy after noninvasive management had ***-four(63.2%)patients underwent a single application,10(26.3%)patients underwent 2 applications,and 4(10.5%)patients underwent 3 ***:Two to 36 mo(average 12 ± 3 mo)following treatment,34 patients were interviewed(four were lost to follow-up).Twenty(58.8%)subjects reported complete cure,8(23.5%)subjects reported significant improvement,and 6(17.7%)subjects reported no *** patient(who underwent a colostomy at a regional hospital with no specialized services available for previous bleeding episodes from radiation proctopathy)was cured,and the colostomy was *** patient(2.6%)developed rectal mucosal damage after the second ***:A 4-min application of 4% formalin for hemorrhagic radiation-induced proctopathy under perianal anesthetic infiltration in patients who have received external radial radiation therapy for prostate cancer is simple,reasonably safe,inexpensive,generally well tolerated,and effective.

关键词： Formalin application Radiation proctopathy Rectal bleeding Prostate cancer

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Adaptability of language-related brain network in a low-grade glioma patient

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Neural Regeneration Research 2011年第30期6卷 2372-2375页

作者： Olivera Sveljo Katarina Koprivsek Milos Lucic Diagnostic Imaging Centre Oncology Institute of VojvodinaSremska KamenicaSerbia

Because functional magnetic resonance imaging can be used for dynamic observation of functional cortical changes after brain injuries, we followed up functional magnetic resonance imaging manifestations of a language-related brain network in a low-grade glioma patient. Disease progression and therapy during a 3-year period were followed up at different time points： before and after reoperation, after radiation therapy, and 1 year after irradiation. During the whole 3-year follow-up period, the patient exhibited no neurological deficits while functional magnetic resonance imaging revealed different topologies of the language-related brain network. During disease progression and after irradiation, the language-related brain network was extended or completely transferred to the nondominant （right） hemisphere. In addition, after reoperation and 1 year after irradiation, language areas were primarily found in the language dominant （left） hemisphere. Our results suggest a high level of adaptability of the language-related cortical network of the bilateral hemispheres in this low-grade glioma patient.

关键词： functional magnetic resonance imaging low-grade glioma cortical changes language-related brain network

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Maximum standardized uptake value on PET/CT in preoperative assessment of lymph node metastasis from thoracic esophageal squamous cell carcinoma

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Chinese Journal of Cancer 2014年第4期33卷 211-217页

作者： Amos JM Ela Bella Ya-Rui Zhang Wei Fan Kong-Jia Luo Tie-Hua Rong Peng Lin Hong Yang Jian-Hua Fu Department of thoracic Surgery Sun Yat-sen University Cancer Center State Key Laboratory of oncology in South China Collaborative Innovation Center for Cancer Medicine Department of Nuclear Medicine Sun Yat-sen University Cancer Center Guangdong Esophageal Cancer institute

The presence of lymph node metastasis is an important prognostic factor for patients with esophageal *** assessment of lymph nodes in thoracic esophageal carcinoma is essential for selecting appropriate treatment and forecasting disease *** emission tomography combined with computed tomography(PET/CT)is becoming an important tool in the workup of esophageal ***,we evaluated the effectiveness of the maximum standardized uptake value(SUVmax)in assessing lymph node metastasis in esophageal squamous cell carcinoma(ESCC)prior to ***-nine surgical patients with pathologically confirmed thoracic ESCC were retrospectively *** patients underwent radical esophagectomy with pathologic evaluation of lymph *** all had18F-FDG PET/CT scans in their preoperative staging *** had a prior history of *** pathologic status and PET/CT SUVmax of lymph nodes were collected to calculate the receiver operating characteristic(ROC)curve and to determine the best cutoff value of the PET/CT SUVmax to distinguish benign from malignant lymph *** node data from 27 others were used for the validation.A total of 323 lymph nodes including 39 metastatic lymph nodes were evaluated in the training cohort,and 117lymph nodes including 32 metastatic lymph nodes were evaluated in the validation *** cutoff point of the SUVmax for lymph nodes was 4.1,as calculated by ROC curve(sensitivity,80%;specificity,92%;accuracy,90%).When this cutoff value was applied to the validation cohort,a sensitivity,a specificity,and an accuracy of 81%,88%,and 86%,respectively,were *** results suggest that the SUVmax of lymph nodes predicts ***,when an SUVmax of 4.1 was used instead of 2.5,FDG-PET/CT was more accurate in assessing nodal metastasis.

关键词：淋巴结肿大 CT扫描食管癌 PET 评估摄取标准计算机断层扫描

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Does tadalafil prevent erectile dysfunction in patients undergoing radiation therapy for prostate cancer？

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Asian Journal of Andrology 2014年第5期16卷 664-665页

作者： Luca Incrocci Department of Radiation oncology Erasmus MCCancer Institute Rotterdam 3000 CA

Arecently published paper addressed the interesting topic of prevention of erectile dysfunction （ED） with tadalafil, a pbosphodiesterase-type 5 inhibitor （PDE5i） in patients undergoing radiation therapy for localized prostate cancer. Tadalafil 5 mg or placebo was administered once-daily for 24 weeks in patients undergoing external-beam radiotherapy （EBRT） or brachytherapy （BT） for prostate cancer. This randomized trial did not show superior efficacy of the active drug compared with placebo 4-6 weeks after stopping the study drug. Furthermore, patients younger than 65 years did not respond significantlybetter than older patients.

关键词： Does tadalafil prevent

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