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| 1 | Prognostic factors of refractory NSCLC patients receiving anlotinib hydrochloride as the third-or further-line treatment显示文摘Objective:Anlotinib hydrochloride is a multitarget tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor,fibroblast growth factor receptor,platelet-derived growth factor receptor,c-Kit,and c-MET;therefore,it exhibits both antitumor and anti-angiogenetic activities.A phase III trial has shown that anlotinib improved progression-free survival(PFS)and overall survival(OS)in patients with advanced non-small cell lung cancer(NSCLC),who presented with progressive disease or intolerance after standard chemotherapy.This study aimed to analyze the characteristics of patients receiving anlotinib treatment to determine the dominant populations who are fit for the treatment.Methods:Data were collected from March 2015 to January 2017 from a randomized,double-blind,placebo-controlled,multicenter,phase III trial of anlotinib(ALTER0303).A total of 437 patients were enrolled and randomly allocated(2:1)to the anlotinib and placebo groups.Kaplan–Meier analysis and log-rank test were performed to compare PFS and OS.Cox proportional hazards model was adopted for multivariate prognostic analysis.Results:Multivariate analysis indicated that high post-therapeutic peripheral blood granulocyte/lymphocyte ratio and elevated alkaline phosphatase levels were independent risk factors for PFS.Meanwhile,elevated thyroid-stimulating hormone,blood glucose,and triglyceride levels;hypertension;and hand–foot syndrome were independent protective factors of PFS.High posttherapeutic peripheral blood granulocyte/lymphocyte ratio,an Eastern Cooperative Oncology Group(ECOG)score≥2,and the sum of the maximal target lesion length at baseline were independent risk factors of OS,and hypertriglyceridemia was an independent protective factor of OS.Conclusions:This study preliminarily explored the possible factors that affected PFS and OS after anlotinib treatment in patients with advanced refractory NSCLC,and the baseline characteristics of the therapeutically dominant populations were then identified. | Jing Wang Yizhuo Zhao Qiming Wang Li Zhang Jianhua Shi Zhehai Wang Ying Cheng Jianxing He Yuankai Shi Hao Yu Yang Zhao Weiqiang Chen Yi Luo Xiuwen Wang Kejun Nan Faguang Jin Jian Dong Baolan Li Zhujun Liu Baohui Han Kai Li | 2018 | Cancer Biology & Medicine2018，15，4： | 46 |
| 2 | China National Medical Products Administration approval summary:anlotinib for the treatment of advanced non-small cell lung cancer after two lines of chemotherapy显示文摘Background:On May 8,2018,the China National Medical Products Administration(NMPA)approved anlotinib,an orally administered anti-angiogenesis inhibitor,for the treatment of patients with advanced non-small cell lung can-cer(NSCLC)who have progressed after treatment with two or more lines of prior systemic chemotherapy.Main body of the abstract:China NMPA reviewed and inspected a regional double-blinded,placebo-controlled,Phase III trial comparing the overall survival(OS)of NSCLC patients between the anlotinib and placebo arms.A total of 437 patients were randomized(2:1)to receive either anlotinib(n=294)or placebo(n=143)once daily on a 2-week on and 1-week off schedule.Patients with epidermal growth factor receptor(EGFR)or activating anaplastic lymphoma kinase(ALK)genomic tumor aberrations should have disease progression on NMPA-approved therapy.Anlotinib is the first NMPA-approved drug for patients with advanced NSCLC who have progressed on at least two lines of prior systemic chemotherapies in China.The approval was based on a statistically and clinically significant improvement in median OS with anlotinib(9.46 months)compared with placebo[6.37 months;hazard ratio(HR])=0.70,95%confidence interval(CI)=0.55-0.89;two-sided log-rank P=0.002].The confirmed objective response rate(ORR)was 9.2%in the anlotinib arm and 0.7%in the placebo arm.The median duration of response(DoR)was 4.83 months,with a 95%CI of 3.31-6.97 months.The toxicity profile of anlotinib was consistent with that of known anti-angiogenesis inhibitors.Common adverse drug reactions(ADRs)in anlotinib-treated patients included hypertension(67.4%),hand-foot syndrome(43.9%),hemoptysis(14.0%),thyroid stimulating hormone(TSH)elevation(46.6%),and corrected QT interval(QTc)prolongation(26.2%).Short conclusion:Anlotinib demonstrated a clinically significant OS prolongation as a novel therapeutic option for advanced or metastatic NSCLC following at least two lines of chemotherapy. | Ming Zhou Xiaoyuan Chen Hong Zhang Lin Xia Xin Tong Limin Zou Ruimin Hao Jianhong Pan Xiao Zhao Dongmei Chen Yuanyuan Song Yueli Qi Ling Tang Zhifang Liu Rong Gao Yuankai Shi Zhimin Yang | 2019 | Cancer Communications2019，39，1： | 35 |
| 3 | Time constraints for the closing of the Paleo-Asian Ocean in the Northern Alxa Region: Evidence from Wuliji granites显示文摘The Wuliji pluton in the Northern Alxa Region, Inner Mongolia, is the principal part of Shalazhashan Mountain. It belongs to the Zongnaishan-Shalazhashan Arc Zone, northwestern North China Plate, whose north is Engger Us Ophiolite Belt and south is Qagan Qulu Ophiolite Belt. The pluton was emplaced into Upper Carboniferous-Lower Permian Amushan Formation. According to the research about the original Carboniferous Amushan Formation, the lower and middle sections of the Carboniferous Amushan Formation consist of volcanic, clastic, and carbonate rocks, interpreted to represent the sedimentary association of a volcanic arc and back-arc basin; the upper section of the Amushan Formation is a molasse composed of silty shale, sandstone, gravel-bearing sandstone, and conglomerate. The Wuliji pluton consists mainly of biotite monzonitic granite, amphibole-bearing biotite monzonitic granite, and monzonitic granite. Geochemical analyses show that the pluton has both metaluminous and peraluminous characteristics, and on average has SiO2>70 wt%, Al2O3 >14 wt%, and high contents of Na2O+K2O (8.5 wt%), which define a calc-alkaline series. In addition, REE patterns show enrichment of LREE and weak negative Eu anomalies (δ Eu=0.3-1). Altogether, the samples are depleted in Nb, Ta, Ti, P, Sr, and Ba, and enriched in Rb, Th, and K. These geochemical traits are interpreted to reflect an arc component. A secondary ion mass spectrometry (SIMS) U-Pb zircon age of the biotite monzonitic Wuliji pluton in the Northern Alxa Region, Inner Mongolia, is 250.8±2.0 Ma (1σ). Samples have ε Nd (t) values between 0.1 and 1.3, which suggests that the granites were derived from mixing between the crust and mantle. Based on the SIMS age and geochemical characteristics, Wuliji granite is interpreted to be a post-collisional granite, the result of mantle-derived melt and assimilated juvenile arc crust. However, according to the newest international stratigraphic classification standard, the upper section of the Amushan Formation is Lower Permian in age, indicating that the back-arc basin had already closed in Early Permian. We conclude that the Paleo-Asian Ocean represented by the Engger Us Ophiolite Belt subducted southward in Late Carboniferous, at the same time that the trench-arc-basin system formed in the Northern Alxa Region. The Paleo-Asian Ocean was closed in Early Permian and the Northern Alxa Region entered a post-collisional period in the Late Permian, as indicated by the Wuliji granites. This suggests that the genesis of the Wuliji granites is consistent with the pluton emplacement at the upper crust, which occurred widely in the northern margin of the North China Plate in Late Carboniferous to Triassic. | ZHANG Wen WU TaiRan FENG JiCheng ZHENG RongGuo HE YuanKai | 2013 | Science China Earth Sciences2013，56，1： | 26 |
| 4 | Clinical features and outcomes of diffuse large B-cell lymphoma based on nodal or extranodal primary sites of origin:Analysis of 1,085 WHO classified cases in a single institution in China显示文摘Objective: To explore the clinicobiologic features and outcomes of diffuse large B-cell lymphoma(DLBCL)patients in China according to the primary site.Methods: A total of 1,085 patients diagnosed with DLBCL in National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College during a 6-year period were enrolled. Their clinical characteristics and outcomes were analyzed according to the primary site.Results: In the 1,085 patients, 679(62.6%) cases were nodal DLBCL(N-DLBCL) and 406 cases(37.4%) were extranodal DLBCL(EN-DLBCL). The most common sites of N-DLBCL were lymphonodus(64.8%), Waldeyer's ring(19.7%), mediastinum(12.8%) and spleen(2.7%), while in EN-DLBCL, stomach(22.4%), intestine(16.0%),nose and sinuses(8.9%), testis(8.4%), skin(7.9%), thyroid(6.9%), central nervous system(CNS)(6.4%), breast(5.7%), bone(3.4%), and salivary gland(2.7%) were most common. N-DLBCL patients tend to present B symptoms, bulky disease, and elevated LDH more often, while age >60 years, extranodal sites >1, Ann Arbor stage I or II, bone marrow involvement, and Ki-67 index >90% were usually seen in EN-DLBCL. The 5-year overall survival(OS) rate and progression-free survival(PFS) rate for all patients were 62.5% and 54.2%. The 5-year OS rate for patients with N-DLBCL and EN-DLBCL were 65.5% and 56.9%(P=0.008), and the 5-year PFS were57.0% and 49.0%(P=0.020). Waldeyer's ring originated DLBCL possessed the highest 5-year OS rate(83.6%) and PFS rate(76.9%) in N-DLBCL. The top five EN-DLBCL subtypes with favorable prognosis were stomach,breast, nose and sinuses, lung, salivary gland, with 5-year OS rate: 70.3%, 69.6%, 69.4%, 66.7% and 63.6%,respectively. While CNS, testis, oral cavity and kidney originated EN-DLBCL faced miserable prognosis, with 5-year OS rate of 26.9%, 38.2%, and 42.9%.Conclusions: In our study, primary sites were associated with clinical characteristics and outcomes. Compared with EN-DLBCL, N-DLBCL had better prognosis. | Yuankai Shi Ying Han Jianliang Yang Peng Liu Xiaohui He Changgong Zhang Shengyu Zhou Liqiang Zhou Yan Qin Yongwen Song Yueping Liu Shulian Wang Jing Jin Lin Gui Yan Sun | 2019 | Chinese Journal of Cancer Research2019，31，1： | 19 |
| 5 | Forecasting Method of Stock Market Volatility in Time Series Data Based on Mixed Model of ARIMA and XGBoost显示文摘Stock price forecasting is an important issue and interesting topic in financial markets.Because reasonable and accurate forecasts have the potential to generate high economic benefits,many researchers have been involved in the study of stock price forecasts.In this paper,the DWT-ARIMAGSXGB hybrid model is proposed.Firstly,the discrete wavelet transform is used to split the data set into approximation and error parts.Then the ARIMA(0,1,1),ARIMA(1,1,0),ARIMA(2,1,1)and ARIMA(3,1,0)models respectively process approximate partial data and the improved xgboost model(GSXGB)handles error partial data.Finally,the prediction results are combined using wavelet reconstruction.According to the experimental comparison of 10 stock data sets,it is found that the errors of DWT-ARIMA-GSXGB model are less than the four prediction models of ARIMA,XGBoost,GSXGB and DWT-ARIMA-XGBoost.The simulation results show that the DWT-ARIMA-GSXGB stock price prediction model has good approximation ability and generalization ability,and can fit the stock index opening price well.And the proposed model is considered to greatly improve the predictive performance of a single ARIMA model or a single XGBoost model in predicting stock prices. | Yan Wang Yuankai Guo | 2020 | China Communications2020，17，3： | 15 |
| 6 | A phase I study of different doses and frequencies of pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) in patients with standard-dose chemotherapy-induced neutropenia显示文摘Objective: The recommended dose of prophylactic pegylated recombinant human granulocyte-colony stimulating factor(PEG rhG-CSF) is 100 μg/kg once per cycle for patients receiving intense-dose chemotherapy.However, few data are available on the proper dose for patients receiving less-intense chemotherapy. The aim of this phase I study is to explore the proper dose and administration schedule of PEG rhG-CSF for patients receiving standard-dose chemotherapy.Methods:Eligible patients received 3-cycle chemotherapy every 3 weeks.No PEG rhG-CSF was given in the first cycle.Patients experienced grade 3 or 4 neutropenia would then enter the cycle 2 and 3.In cycle 2,patients received a single subcutaneous injection of prophylactic PEG rhG-CSF on d 3,and received half-dose subcutaneous injection in cycle 3 on d 3 and d 5,respectively.Escalating doses(30,60,100 and 200μg/kg)of PEG rhG-CSF were investigated.Results:A total of 26 patients were enrolled and received chemotherapy,in which 24 and 18 patients entered cycle 2 and cycle 3 treatment,respectively.In cycle 2,the incidence of grade 3 or 4 neutropenia for patients receiving single-dose PEG rhG-CSF of 30,60,100 and 200 μg/kg was 66.67%,33.33%,22.22% and 0,respectively,with a median duration less than 1(0–2)d.No grade 3 or higher neutropenia was noted in cycle 3 in all dose cohorts.Conclusions:The pharmacokinetic and pharmacodynamic profiles of PEG rhG-CSF used in cancer patients were similar to those reported,as well as the safety.Double half dose administration model showed better efficacy result than a single dose model in terms of grade 3 neutropenia and above.The single dose of 60 μg/kg,100 μg/kg and double half dose of 30 μg/kg were recommended to the phase Ⅱ study,hoping to find a preferable method for neutropenia treatment. | Yan Qin Xiaohong Han Lin Wang Ping Du Jiarui Yao Di Wu Yuanyuan Song Shuxiang Zhang Le Tang Yuankai Shi | 2017 | Chinese Journal of Cancer Research2017，29，5： | 11 |
| 7 | Permian High Ba-Sr Granitoids:Geochemistry,Age and Tectonic Implications of Erlangshan Pluton,Urad Zhongqi,Inner Mongolia显示文摘从 Urad Zhongqi 的 Erlangshan Pluton,中央内部蒙古,位于北方中国板的北边缘的中间的片断。岩石与片麻岩的结构主要由闪长岩组成。石油化学的特征表明闪长岩属于遇见了铝土的、高钾的计算碱的系列,与我类型花岗石的化学签名。他们被低 SiO 2内容描绘(56.63%58.53%)并且 A/CNK ( 0.90 0.96 ),高级艾尔 2 O 3内容(17.30%17.96%)并且 Na 2 O/K 2 O 比率( 1.20 1.70 ),在大离子亲石元素元素的丰富( LILE ,例如, Ba=556 915 ppm , Sr=463 595 ppm ),并且在高地力量元素的相对弄空( HFSE ,例如, Nb , Ta , Ti )在原始使披风正常化的蜘蛛克,和有稍微否定的 Eu 异例的衰退权利的稀土元素元素模式( δEu=0.72 0.90 )。他们有 Sr/Y 比率(20 25 ) 显然不到 Kebu Pluton (49 75 ) 到它的东方。微探查的 U-Pb 锆石标明日期闪长岩产出的敏感高分辨率离子 270 ± 8 妈的恼人的年龄。这导致我们断定 Erlangshan 闪长岩被在中间或更低的外壳导出岩浆和次要的导出披风的 mafic 岩浆之间混合形成,由部分结晶化列在后面,它在 post-collisional 设定是由外壳的扩展和差错活动的 trigged。 | LUO Hongling,WU Tairan~*,ZHAO Lei,HE Yuankai and JIN Xu The Key Laboratory of Orogenic Belts and Crustal Evolution,Ministry of Education,Beijing 100871, China School of Earth and Space Sciences,Peking University,Beijing 100871,China | 2009 | Acta Geologica Sinica(English Edition)2009，83，3： | 9 |
| 8 | Autologous hematopoietic stem cell transplantation in chemotherapy-sensitive lymphoblastic lymphoma: treatment outcome and prognostic factor analysis显示文摘Objective: The study evaluated the effectiveness of autologous hematopoietic stem cell transplantation(AHSCT) in the treatment of lymphoblastic lymphoma(LL).Methods: We retrospectively analyzed the data from 41 patients with chemotherapy-sensitive LL who underwent hematopoietic stem cell transplantation(HSCT) from December 1989 to December 2009 in a single institution.Results: HSCT was conducted as first-line consolidation therapy and salvage therapy in 36 and 5 patients, respectively. The median follow-up was 97.1 months(range, 24.6-173.1 months). The 5-year overall survival(OS) and event-free survival(EFS) rate were 64% and 47% for the initially treated patients, respectively, and were both 20% for the relapsed ones. Bone marrow(BM) involvement and chemotherapy cycles prior to transplantation were identified as significant prognostic factors for EFS in multivariate analysis.Conclusions: These results confirm that AHSCT is a reasonable option for chemotherapy-sensitive LL patients in first complete remission(CR1). | Youwu Shi Shengyu Zhou Xiaohui He Xiaohong Han Shikai Wu Feng Pan Peng Liu Yinyu Liu Yingheng Lei Hongzhi Zhang Jianliang Yang Yan Qin Changgong Zhang Sheng Yang Liya Zhao Kehuan Luo Guanqing Wu Yan Sun Yuankai Shi | 2015 | Chinese Journal of Cancer Research2015，27，1： | 9 |
| 9 | Aeration optimization through operation at low dissolved oxygen concentrations:Evaluation of oxygen mass transfer dynamics in different activated sludge systems显示文摘In wastewater treatment plants(WWTPs)using the activated sludge process,two methods are widely used to improve aeration efficiency — use of high-efficiency aeration devices and optimizing the aeration control strategy. Aeration efficiency is closely linked to sludge characteristics(such as concentrations of mixed liquor suspended solids(MLSS)and microbial communities)and operating conditions(such as air flow rate and operational dissolved oxygen(DO)concentrations). Moreover,operational DO is closely linked to effluent quality. This study,which is in reference to WWTP discharge class A Chinese standard effluent criteria,determined the growth kinetics parameters of nitrifiers at different DO levels in small-scale tests. Results showed that the activated sludge system could meet effluent criteria when DO was as low as 0.3 mg/L,and that nitrifier communities cultivated under low DO conditions had higher oxygen affinity than those cultivated under high DO conditions,as indicated by the oxygen half-saturation constant and nitrification ability. Based on nitrifier growth kinetics and on the oxygen mass transfer dynamic model(determined using different air flow rate(Q′_(air))and mixed liquor volatile suspended solids(MLVSS)values),theoretical analysis indicated limited potential for energy saving by improving aeration diffuser performance when the activated sludge system had low oxygen consumption; however,operating at low DO and low MLVSS could significantly reduce energy consumption. Finally,a control strategy coupling sludge retention time and MLVSS to minimize the DO level was discussed,which is critical to appropriate setting of the oxygen point and to the operation of low DO treatment technology. | Haitao Fan Lu Qi Guoqiang Liu Yuankai Zhang Qiang Fan Hongchen Wang | 2017 | Journal of Environmental Sciences2017，29，5： | 9 |
| 10 | Molecular, Functional, and Structural Imaging of Major Depressive Disorder显示文摘Major depressive disorder(MDD) is a significant cause of morbidity and mortality worldwide,correlating with genetic susceptibility and environmental risk factors.Molecular,functional,and structural imaging approaches have been increasingly used to detect neurobiological changes,analyze neurochemical correlates,and parse pathophysiological mechanisms underlying MDD.We reviewed recent neuroimaging publications on MDD in terms of molecular,functional,and structural alterations as detected mainly by magnetic resonance imaging(MRI) and positron emission tomography.Altered structure and function of brain regions involved in the cognitive control of affective state have been demonstrated.An abnormal default mode network,as revealed by resting-state functional MRI,is likely associated with aberrant metabolicand serotonergic function revealed by radionuclide imaging.Further multi-modal investigations are essential to clarify the characteristics of the cortical network and serotonergic system associated with behavioral and genetic variations in MDD. | Kai Zhang Yunqi Zhu Yuankai Zhu Shuang Wu Hao Liu Wei Zhang Caiyun Xu Hong Zhang Takuya Hayashi Mei Tian | 2016 | Neuroscience Bulletin2016，32，3： | 9 |
| 11 | Analysis of key microbial community during the start-up of anaerobic ammonium oxidation process with paddy soil as inoculated sludge显示文摘A sequencing batch reactor(SBR)-anaerobic ammonium oxidation(anammox) system was started up with the paddy soil as inoculated sludge. The key microbial community structure in the system along with the enrichment time was investigated by using molecular biology methods(e.g., high-throughput 16 S r RNA gene sequencing and quantitative PCR). Meanwhile,the influent and effluent water quality was continuously monitored during the whole start-up stage. The results showed that the microbial diversity decreased as the operation time initially and increased afterwards, and the microbial niches in the system were redistributed. The anammox bacterial community structure in the SBR-anammox system shifted during the enrichment, the most dominant anammox bacteria were Candidatus Jettenia. The maximum biomass of anammox bacteria achieved 1.68 × 10~9 copies/g dry sludge during the enrichment period, and the highest removal rate of TN achieved around 75%. | Xianglong Xu Guohua Liu Yuanyuan Wang Yuankai Zhang Hao Wan Lu Qi Hongchen Wang | 2018 | Journal of Environmental Sciences2018，30，2： | 8 |
| 12 | Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)显示文摘Background:Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer(sqNSCLC)after failure of first-line chemotherapy are limited.This study(ORIENT-3)aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.Methods:ORIENT-3 was an open-label,multicenter,randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy.Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m^(2) of docetaxel intravenously every 3 weeks,stratified by the Eastern Cooperative Oncology Group performance status.The primary endpoint was overall survival(OS)in the full analysis set(FAS).Secondary endpoints included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),duration of response(DoR)and safety.Results:Between August 25,2017,and November 7,2018,290 patients were randomized.For FAS,10 patients fromthe docetaxel armwere excluded.Themedian OS was 11.79(n=145;95%confidence interval[CI],10.28-15.57)months with sintilimab versus 8.25(n=135;95%CI,6.47-9.82)months with docetaxel(hazard ratio[HR]:0.74;95%CI,0.56-0.96;P=0.025).Sintilimab treatment significantly prolonged PFS(median 4.30 vs.2.79 months;HR:0.52;95%CI,0.39-0.68;P<0.001)and showed higher ORR(25.50%vs.2.20%,P<0.001)and DCR(65.50%vs.37.80%,P<0.001)than the docetaxel arm.The median DoRwas 12.45(95%CI,4.86-25.33)months in the sintilimab arm and 4.14(95%CI,1.41-7.23)months in the docetaxel arm(P=0.045).Treatment-related adverse events of grade≥3were reported in 26(18.1%)patients in the sintilimab arm and 47(36.2%)patients in the docetaxel arm.Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors,including OVOL2(HR:0.35;P<0.001)and CTCF(HR:3.50;P<0.001),for sintilimab treatment.Conclusions:Compared with docetaxel,sintilimab significantly improved the OS,PFS,and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC. | Yuankai Shi Lin Wu Xinmin Yu Puyuan Xing Yan Wang Jianying Zhou Airong Wang Jianhua Shi Yi Hu Ziping Wang Guangyu An Yong Fang Sanyuan Sun Caicun Zhou Changli Wang Feng Ye Xingya Li Junye Wang Mengzhao Wang Yunpeng Liu Yanqiu Zhao Ying Yuan Jifeng Feng Zhendong Chen Jindong Shi Tao Sun Gang Wu Yongqian Shu Qisen Guo Yi Zhang Yong Song Shucai Zhang Yuan Chen Wei Li Hongrui Niu Wenwei Hu Lijun Wang Jianan Huang Yang Zhang Ying Cheng Zhengdong Wu Bo Peng Jiya Sun Christoph Mancao Yanqi Wang Luyao Sun | 2022 | Cancer Communications2022，42，12： | 8 |
| 13 | 中国国家药品监督管理局批准安罗替尼用于经两种系统化疗后疾病进展的晚期非小细胞肺癌的治疗显示文摘背景2018年5月8日,中国国家药品监督管理局(National Medical Products Administration,NMPA)批准了小分子多靶点抗血管抑制剂盐酸安罗替尼,用于既往经过至少两种系统化疗后疾病进展的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的治疗。概要中国NMPA审查了一项随机双盲、安慰剂对照的III期临床试验,该临床试验的主要终点为总生存期(overall survival,OS)。试验共纳入437例患者随机分组(2∶1)接受安罗替尼(n=294)或安慰剂(n=143)治疗,每日1次,连服2周,停药1周。表皮生长因子受体(epidermal growth factor receptor,EGFR)基因敏感突变或间变性淋巴瘤激酶(activating anaplasticlymphomakinase,ALK)阳性的患者须经过NMPA已批准的药物治疗后出现疾病进展。安罗替尼为中国NMPA批准的用于治疗既往经过两种及以上系统化疗后疾病进展的晚期NSCLC患者的首个药物。安罗替尼组的中位OS(9.46个月)较安慰剂组[6.37个月;风险比(hazard ratio,HR)=0.70,95%置信区间(confidence Interval,CI):0.55–0.89;双侧log-rank P=0.002]显著延长。安罗替尼组的客观缓解率(objective responserate,ORR)为9.2%,安慰剂组为0.7%。安罗替尼组的中位缓解持续时间(durationofresponse,DoR)为4.83个月,95%CI为3.31–6.97个月。安罗替尼的常见不良反应(adverse drug reactions,ADRs)包括高血压(67.4%)、手足综合征(43.9%)、咳血(14.0%)、促甲状腺激素(thyroid stimulating hormone,TSH)升高(46.6%)、心电图QT间期(corrected QT Interval,QTc)延长(26.2%)。结论安罗替尼显著延长了患者的OS,可作为经二线及以上化疗后晚期或转移性非小细胞肺癌的一种新的治疗方案。 | Ming Zhou Xiaoyuan Chen Hong Zhang Lin Xia Xin Tong Limin Zou Ruimin Hao Jianhong Pan Xiao Zhao Dongmei Chen Yuanyuan Song Yueli Qi Ling Tang Zhifang Liu Rong Gao Yuankai Shi Zhimin Yang | 2019 | 癌症2019，38，12： | 7 |
| 14 | PhaseⅠdose-finding study of sorafenib with FOLFOX4 as firstline treatment in patients with unresectable locally advanced or metastatic gastric cancer显示文摘Objective: To determine the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) and efficacy of sorafenib in combination with FOLFOX4(oxaliplatin/leucovorin(LV)/5-fluorouracil) as first-line treatment for advanced gastric cancer, we performed a phase I dose-finding study in nine evaluable patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Methods: According to modified Fibonacci method, the design of this study was to guide elevation of the sorafenib dosage to the next level(from 200 mg twice daily to 400 mg twice daily and then, if tolerated, 600 mg twice daily). If the patient achieved complete response(CR), partial response(PR) or stable disease(SD) after eight cycles of treatment, combination chemotherapy was scheduled to be discontinued and sorafenib monotherapy continued at the original dose until either disease progression or unacceptable toxicity. Results: In sorafenib 200 mg twice daily group, DLT was observed in 1 of 6 patients, and in 400 mg twice daily group, it was observed in 2 of 3 patients. Seven of 9(77.8%) evaluable patients achieved PR, with a median overall survival(OS) of 11.8 [95% confidence interval(CI): 8.9-14.7] months. Common adverse effects include hand-foot syndrome, leukopenia, neutropenia, anorexia, and nausea.Conclusions: Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 was proven effective and safe for the treatment of advanced gastric cancer, and could be an appropriate dosage for subsequent phase II clinical studies. | Yihebali Chi Jianliang Yang Sheng Yang Yongkun Sun Bo Jia Yuankai Shi | 2015 | Chinese Journal of Cancer Research2015，27，3： | 6 |
| 15 | A phaseⅠtrial of an oral subtype-selective histone deacetylase inhibitor,chidamide,in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer显示文摘Objective: This phase Ⅰ study was to evaluate safety, maximum tolerated dose, pharmacokinetics and preliminary antitumor activity of chidamide, a novel subtype-selective histone deacetylase(HDAC) inhibitor, in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer(NSCLC).Methods: Ten patients received oral chidamide 20, 25, or 30 mg twice per week continuously with paclitaxel(175 mg/m^2) and carboplatin [area under the curve(AUC) 5 mg/m L/min] administered in a 3-week cycle. Patients with response and stable disease after four cycles maintained chidamide monotherapy until disease progression or unacceptable toxicity. Blood samples were collected for pharmacokinetic analysis after the first single oral of chidamide and first combination treatment in cycle 1 from all patients.Results: Two dose-limiting toxicities were recorded in the 30 mg cohort, including thrombocytopenia and prolonged neutropenia in the first cycle. Grade 3/4 neutropenia in any cycle was observed in all patients, but was not associated with significant complications. Other grade 3/4 hematologic toxicities included thrombocytopenia and leucopenia. No significant changes were observed in pharmacokinetic parameters for both chidamide and paclitaxel. One patient in the 20 mg cohort had confirmed partial response(PR). Two out of 5 patients with brain metastases had intracranial complete remission after 4-cycle treatment.Conclusions: Chidamide combined with paclitaxel and carboplatin was generally tolerated without unanticipated toxicities or clinically relevant pharmacokinetic interactions. The recommended dose for chidamide in this combination was established at 20 mg, and a phase Ⅱ trial is ongoing with this regimen in patients with advanced NSCLC. | Xingsheng Hu Lin Wang Lin Lin Xiaohong Han Guifang Dou Zhiyun Meng Yuankai Shi | 2016 | Chinese Journal of Cancer Research2016，28，4： | 6 |
| 16 | Current state and future perspectives of sewer networks in urban China显示文摘中国当局和公众大部分忽略了下水道网络;然而,各种各样的问题与新下水道的增加构造全国正在出现。在中国的下水道网络建设,管理,和维护的当前的国家包括地在这研究被考察。为大约 4.44 亿个人,服务下水道线的 511,200 km 位于城市的区域。在 2014, 70 亿美元在下水道网络建设被投资。然而,下水道扩散率和人均的下水道长度是比在发达国家的那些显著地低的。在本地政府的下水道行政机构是不协调的。法律,规定,和标准是不完全的,并且一些惯例是非科学的。因为下水道腐蚀控制措施没被发射,下水道维护的未来状况是极其冷酷的。而且,检查和康复主要依靠传统的途径。相反,创新技术的全面市场份额由于高费用,资金缺乏,和技术限制是很低的。象班机倒置 cured-in-place 那样的途径尖叫,开车进入用餐的餐厅紫外轻治好的班机,和螺线创伤衬里主要在经济地发达的区域被使用。根据地位和问题分析,瓷器最高的优先级将是以后在下水道网络进行好攻击的维护工作。新技术线路,腐蚀控制 - 周期的设想的检查 - 无沟的康复,能是为在中国的未来下水道维护的最好的选择。为使用这条技术线路的指令和机会在这研究详细被讨论。最后,在在中国的下水道网络的开发的另外的因素被建议。 | Dong Huang Xiuhong Liu Songzhu Jiang Hongchen Wang Junyan Wang Yuankai Zhang | 2018 | Frontiers of Environmental Science & Engineering2018，12，3： | 5 |
| 17 | Comparison of immunohistochemistry with fluorescence in situ hybridization in determining the human epidermal growth factor receptor 2 status of breast cancer specimens: a multicenter study of 3149 Chinese patients显示文摘 | Han Xiaohong Shi Yuankai Ma Li Lyu Zheng Yang Hongying Yao Jiarui Li Jian Li Bo Qin Yan | 2014 | Chinese Medical Journal2014，，2： | 5 |
| 18 | Phase I study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin's lymphoma显示文摘Objective: This study was designed to determine the safety, pharmacokinetics and biologic effects of a humanmouse chimeric anti-CD20 monoclonal antibody(SCT400) in Chinese patients with CD20-positive B-cell nonHodgkin's lymphoma(CD20+ B-cell NHL). SCT400 has an identical amino acid sequence as rituximab, with the exception of one amino acid in the CH1 domain of the heavy chain, which is common in Asians.Methods: Fifteen patients with CD20+ B-cell NHL received dose-escalating SCT400 infusions(250 mg/m^2: n=3; 375 mg/m^2: n=9; 500 mg/m^2: n=3) once weekly for 4 consecutive weeks with a 24-week follow-up period. The data of all patients were collected for pharmacokinetics and pharmacodynamics analyses.Results: No dose-limiting toxicities were observed. Most drug-related adverse events were grade 1 or 2. Two patients had grade 3 or 4 neutropenia. Under premedication, the drug-related infusion reaction was mild. A rapid, profound and durable depletion of circulating B cells was observed in all dose groups without significant effects on T cell count, natural killer(NK) cell count or immunoglobulin levels. No patient developed antiSCT400 antibodies during the course of the study. SCT400 serum half-life(T1/2), maximum concentration(Cmax) and area under the curve(AUC) generally increased between the first and fourth infusions(P<0.05). At the 375 mg/m^2 dose, the T1/2 was 122.5±46.7 h vs. 197.0±75.0 h, respectively, and the Cmax was 200.6±20.2 μg/m L vs. 339.1±71.0 μg/m L, respectively. From 250 mg/m^2 to 500 mg/m^2, the Cmax and AUC increased significantly in a dose-dependent manner(P<0.05). Patients with a high tumor burden had markedly lower serum SCT400 concentrations compared with those without or with a low tumor burden. Of the 9 assessable patients, 1 achieved complete response and 2 achieved partial responses.Conclusions: SCT400 is well-tolerated and has encouraging preliminary efficacy in Chinese patients with CD20+ B-cell NHL. | Lin Gui Xiaohong Han Xiaohui He Yuanyuan Song Jiarui Yao Jianliang Yang Peng Liu Yan Qin Shuxiang Zhang Weijing Zhang Wenlin Gai Liangzhi Xie Yuankai Shi | 2016 | Chinese Journal of Cancer Research2016，28，2： | 5 |
| 19 | Clinical features, survival and prognostic factors of primary testicular diffuse large B-cell lymphoma显示文摘Objective: To assess the clinical features, survival and prognostic factors of primary testicular diffuse large B-cell lymphoma(DLBCL).Methods: A retrospective study of 37 patients with primary testicular DLBCL was carried out from November 2003 to May 2012. Their clinical features, survival and prognostic factors were analyzed.Results: During a median follow-up period of 39.8 months(5.4-93.0 months), the median progression-free survival(PFS) was 26.2 months(95% CI: 0-65 months) and the 3-year overall survival(OS) rate was 78.4%. Within the whole cohort, the factors significantly associated with a superior PFS were limited stage(stage I/II), lactate dehydrogenase(LDH) ≤245 U/L, international prognostic index(IPI) ≤1, primary tumor diameter <7.5 cm, and patients who had complete response(CR) and received doxorubicin-contained chemotherapy(P<0.05). There was a trend toward superior outcome for patients who received combined therapy(surgery/chemotherapy/radiotherapy)(P=0.055). Patients who had CR, primary tumor diameter <7.5 cm and IPI score ≤1 were significantly associated with longer PFS at multivariate analysis.Conclusions: Primary testicular DLBCL had poorer survival. CR, primary tumor diameter and IPI were independent prognostic factors. The combined therapy of orchectomy, doxorubicin-contained chemotherapy and contralateral testicular radiotherapy(RT) seemed to improve survival. | Bo Jia Yuankai Shi Mei Dong Fengyi Feng Sheng Yang Hua Lin Liqiang Zhou Shengyu Zhou Shanshan Chen Jianliang Yang Peng Liu Yan Qin Changgong Zhang Lin Gui Lin Wang Xue Wang Xiaohui He | 2014 | Chinese Journal of Cancer Research2014，26，4： | 5 |
| 20 | 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显示文摘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 groups.Conclusions: Treatment with HLX01 was safe and well tolerated in Chinese patients with B-cell lymphoma.HLX01 and rituximab-CN have similar pharmacokinetic, pharmacodynamic and safety profiles. | 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 | 2021 | Chinese Journal of Cancer Research2021，33，3： | 5 |
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