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| 1 | 帕博利珠单抗治疗伴脑转移NSCLC患者的一项非随机、开放Ⅱ期试验的长期随访结果和生物标志物分析显示文摘背景与目的我们开展了一项帕博利珠单抗用于伴未治疗脑转移的非小细胞肺癌(non-small cell lung cancer,NSCLC)或黑色素瘤患者的疗效和安全性的II期试验,旨在评估程序性死亡受体1(programmed cell death 1,PD-1)抑制剂在中枢神经系统(central nervous system,CNS)中的疗效。中期结果已发表,现报道对NSCLC队列的更新分析结果。方法这是一项开放性、单中心、II期试验。纳入标准:年龄≥18岁,诊断为晚期NSCLC并伴有≥1个5 mm-20 mm脑转移病灶,既往从未治疗或之前放疗后进展,无神经系统症状,不需要激素治疗且美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)<2分。患者每2周接受一次帕博利珠单抗(10 mg/kg)治疗。队列1为程序性死亡配体1(programmed cell death ligand 1,PD-L1)≥1%的患者,队列2为PD-L1<1%或未评估的患者。主要终点是脑转移患者缓解比例。所有经治患者均纳入疗效与安全性终点的分析。该研究已结束入组,并于Clinicaltrials.gov登记注册,注册号为NCT02085070。结果2014年3月31日-2018年5月21日,共42例患者接受治疗。中位随访时间为8.3个月(IQR:4.5个月-26.2个月)。队列1的37例患者中11例有脑转移缓解[29.7%(95%CI:15.9%-47.0%)]。队列2未观察到缓解。治疗相关的3级-4级不良事件(adverse events,AEs)包括2例肺炎、1例全身症状、1例结肠炎、1例肾上腺皮质功能不全、1例高血糖症和1例低钾血症。6例(14%)患者发生了治疗相关的严重不良事件,包括肺炎、急性肾损伤、低钾血症和肾上腺皮质功能不全。没有观察到治疗相关死亡病例。结论帕博利珠单抗治疗PD-L1≥1%的NSCLC伴脑转移患者有效,且对所有纳入的未经治疗的脑转移患者安全。需要进一步探索免疫治疗用于NSCLC合并CNS转移。 | Sarah B GOLDBERG Kurt A SCHALPER Scott N GETTINGER Amit MAHAJAN Roy S HERBST Anne C CHANG Rogerio LILENBAUM Frederick H WILSON Sacit Bulent OMAY James B YU Lucia JILAVEANU Thuy TRAN Kira PAVLIK Elin ROWEN Heather GERRSH Annette KOMLO Richa GUPTA Hailey WYATT Matthew RIBEIRO Yuval KLUGER Geyu ZHOU Wei WEI Veronica L CHANG Harriet M KLUGER 董晓荣(翻译/校对) | 2021 | 中国肺癌杂志2021，24，9： | 34 |
| 2 | Properties and failure mechanisms of pinned composite lap joints in monotonic and cyclic tension 显示文摘 | CHANG P MOURITZ A P COX B N | 2006 | Composites Science and Technology2006，66，13： | 1 |
| 3 | Prediction analysis of solid waste generation based on grey fuzzy dynamic modeling 显示文摘 | Chen HW Chang N B | 2000 | Re- sources Conservation and Recycling2000，29，2： | 1 |
| 4 | Exploring spatiotemporal patterns of phosphorus concentrations in a coastal bay with MODIS images and machine learning models显示文摘 | Chang N B Xuan Z M Yang Y J | 2013 | Remote Sensing of Environment2013，134，： | 1 |
| 5 | Design of a GIS-based Decision Support System for Chemical Emergency Preparedness and Response in an Urban Environment Com-puters显示文摘 | Chang N B Wei Y L Tseng C C et at | | 0，，01： | 1 |
| 6 | Interacting loci cause severe iris atrophy and glaucoma in DBA/2J mice 显示文摘 | Chang B Smith R Hawes N | 1999 | Nature Genet1999，21，： | 1 |
| 7 | Fractionation of organic matters in sludge rejected by NF membrane 显示文摘 | Tsaia B N Chang C H Lee D J | 2008 | Desalination2008，234，13： | 1 |
| 8 | Production and characterization of Monoclonal antibodies to Aeromona ssobria surface Antigens FEMS显示文摘 | CHANG B J | 1989 | Microbio Immunol1989，47，89： | 1 |
| 9 | Identification of river water quality using the fuzzy synthetic evaluation approach 显示文摘 | Chang N B Chen H W Ning S K | 2001 | Environmental Management2001，63，： | 1 |
| 10 | Retinal neuronal MCP-l induced by AGEs stimulates TNF-a expression in rat microglia via p38, ERK,and NF-KB pathways显示文摘 | Dong N Chang L Wang B | 2014 | Mol Vis2014，20，： | 1 |
| 11 | Inflammation and bone erosion are suppressed in models of rheumatoid arthritis following treatment with a novel Syk inhibitor 显示文摘 | Pine PR Chang B Schoettler N | 2007 | Clin Immunol2007，124，3： | 1 |
| 12 | Integrating spatial fuzzy clus- lering with level set methods for automated medical image segmenta- tion显示文摘 | LI B N CHUI C K CHANG S | 2011 | Computers in Biology and Medicine2011，41，1： | 1 |
| 13 | Temperature effects on functionalized filter media fornutrient removal in stormwater treatment 显示文摘 | CHANG N B WANIELISTA M P HENDERSON D | 2011 | Environmental Progress and Sustainable Energy2011，30，3： | 1 |
| 14 | Transperinealbiopsy of the prostate-is this the future显示文摘 | Chang DT Challacombe B Lawrentschuk N | 2013 | Nat Rev Urol2013，10，12： | 1 |
| 15 | Structural strength of bridge decks reinforced with welded wire fabric显示文摘 | Ayyub B M Al-Mutairi N Chang P | 1996 | Journal of Structural Engineering1996，122，9： | 1 |
| 16 | Effects of chromium on health status,blood neutrophil phagocytosis and in vitro lymphocyte blastogenesis of dairy cows显示文摘 | CHANG X MALLARD B A MOWAT D N | 1996 | Veterinary Immunology and Immunopathology1996，52，12： | 1 |
| 17 | Soil erosion and nonpoint source pollution impacts assessment with the aid of multitemporal remote sensing images 显示文摘 | Ning S K Chang N B Jeng K Y | 2006 | Journal of Environmental Management2006，79，1： | 1 |
| 18 | Growth characteristics of infantile hemangiomas: Implications for manage- ment显示文摘 | CHANG L C HAGGSTROM A N DROLET B A | 2008 | Pediatrics2008，122，2： | 1 |
| 19 | Production of Bacillus thuringiensisspore in total cell retention culture and two stage continous cultrure usingan internal ceramic filter system显示文摘 | KANG B C LEE S Y CHANG H N | 1993 | Biotechnology and Bioengineering1993，42，9： | 1 |
| 20 | Stability Analysis of Grey Compromise Programming and its Applications显示文摘 | Chang N B Yeh S C Wu G C | 1999 | International Journal of Systems Science1999，30，6： | 1 |
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