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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 | Small interfering RNA-induced suppression of ERCC1 enhances sensitivity of human cancer cells to cisplatin显示文摘 | CHANG I Y KIM M H KIM H B | 2005 | Bioehem Biophys Res Commun2005，327，1： | 1 |
| 3 | Testing Object-Oriented programs:from formal Specification to test scenario generation显示文摘 | S S Liao S B Seidman | 1998 | The Journal of systems and software1998，42，： | 1 |
| 4 | Protective effects of recombinant staphylococcal enterotoxin type C mutant vaccine against experimental bovine infection by a strain of Staphylococcus aureus isolated from subclinical mastitis in dairy cattle Vaccine显示文摘 | Chang B S Moon J S Kang H M | 2008 | 17:2081-20912008，17，： | 1 |
| 5 | Biodegradation of polycyclic aromatic hydrocarbons by a mixed culture显示文摘 | Yuan S Y Wei S H Chang B V | 2000 | Chemosphere2000，41，： | 1 |
| 6 | FSA-based link assignment and routing in low earth orbit satellite networks显示文摘 | Chang H S Kim B W | 1998 | IEEE Transactions on Vehicular Technology1998，47，3： | 1 |
| 7 | Effect of acetylene in buffer gas on the microstructures of carbon nanotubes in arc discharge显示文摘 | TANG D S XIE S S CHANG B H | 2002 | Nanotechnology2002，13，： | 1 |
| 8 | Novel BOD sensor using mediator-less microbial fuel cell 显示文摘 | Kim B H Chang I S Gil G C | 2003 | Biotechnology Letters2003，25，7： | 1 |
| 9 | Buckytubes and derivatives:their growth and implications for buckyball formation显示文摘 | DRAVID V P LIN X WANG X K YEE A KETTERSON J B CHANG R P H | 1993 | Science1993，259，： | 1 |
| 10 | Multiple flavonoid binding sites within multidrug resistance protein MRP1显示文摘 | Trompier D Baubichon-Cortay H Chang X B | 2003 | Cell Mol Life Sci2003，60，： | 1 |
| 11 | Synthesis of cubic and rhombohedral phased nanocrystalline SnO2 doped In2O3 powders with coprecipitation method 显示文摘 | Kim B C Kim J J Chang S H | 2000 | Mat Res Soc2000，，581： | 1 |
| 12 | Changes in the microstructure and hydrogen storage properties of Ti℃r-V alloys by ball milling and heat treatment 显示文摘 | CHO S W YOO J H CHANG H K KIM W B KIL D S AHN J G | 2011 | Journal of Alloys and Compounds2011，509，18： | 1 |
| 13 | Fuzzy Regression Methods-a Comptive Assessment显示文摘 | Chang Y H O Ayyub B M | 2001 | Fuzzy Sets and Systems2001，119，： | 1 |
| 14 | Evaluation on speciation and removal efficiencies of mercury from municipal solid waste incinerators in Taiwan显示文摘 | CHANG M B WU H T HUANG C K | 2000 | Sci Total Environ2000，246，23： | 1 |
| 15 | A 16-channel low-power non-uniform spaced filter bank core for digital hearing aids显示文摘 | CHONG K S GWEE B H CHANG J S | 2006 | IEEE Transactions on Circuits and Systems:Express Briefs2006，53，10： | 1 |
| 16 | Species variation in lignin显示文摘 | SARKANEN K V CHANG H M ERICSSON B | 1967 | Tappi1967，50，11： | 1 |
| 17 | Effects of Chinese herbal polysaccharidds on the immunity and growth performance of young broilers显示文摘 | CHEN H L LID F CHANG B Y | 2003 | Poult Sci2003，82，3： | 1 |
| 18 | Mango malformation disease in South China caused by Fus arium p roliferotum显示文摘 | ZHAN R L YANG S J HO H H LIU F ZHAO Y L CHANG J M HE Y B | 2010 | Journal of Phytopathology2010，158，： | 1 |
| 19 | H∞ tracking design of un- certain nonlinear SISO systems显示文摘 | Chen B S Lee C H Chang Y C | 1996 | IEEE Transactions on Fuzzy Systems1996，4，1： | 1 |
| 20 | 查看详情显示文摘 | Jou M J Lin J F Chang C M Lin C H Wu M C Lee B J | | 0，，： | 1 |
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