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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 | Biolistic transformation of Chrysanthemum with the nucleocapsid gene of tomato spotted wilt virus显示文摘 | Yepes L M Veronica M Pang SZ | 1995 | Plant Cell Reports1995，14，： | 1 |
| 3 | The effect of dietary docosahexaenoic acid (DHA)on growth,survival and pigmentation of California halibut Paralichthys californicus larvae ( Ayres, 1810 ) 显示文摘 | Veronica V O Juan P L a Benjamin B S | 2010 | Aquaculture2010，302，： | 1 |
| 4 | Periodontitis and Periodontal Disease - innovative strategies for reversing the chronic infectious and inflammatory condition by natural products显示文摘 | Veronica L Saviuc CM Chifiriuc MC | 2015 | Curr Pharm Des2015，12，15： | 1 |
| 5 | Temperature and emulsifier concentration effects on gallic acid distribution in a model food emulsion显示文摘 | SONIA L B VERONICA S P | 2012 | Journal of Colloid and Interface Science2012，，370： | 1 |
| 6 | Leptin surge precedes onset of autoimmune encephalomyelitis and correlates with development of pathogenic T cell responses显示文摘 | Veronica S Antonio D Antonio L | 2003 | J Clin Invest2003，111，2： | 1 |
| 7 | A pseudoautoso mal random amplified polymorphic DNA marker for the sex chromosomes of Silene dioica 显示文摘 | Veronica S D Kesseli R V Muleahy D L | 1998 | Genetics1998，149，： | 1 |
| 8 | Synthetic opals based on silica-coated gold nanoparticles显示文摘 | Florencio G S Veronica S M Cefe L | 2002 | Langmuir2002，18，： | 1 |
| 9 | Developmentand in–house validation of a robust and sensitive solid–phaseextraction liquid chromatography/tandem mass spectrometrymethod for the quantitative determination of aflatoxins B1,B2,G1,G2,ochratoxin A,deoxynivalenol,zearalenone,T–2 andHT–2 toxins in cereal–based foods显示文摘 | Veronica M T L Gatta S D Suman M | 2011 | Rapid Commun MassSpectrom2011，25，13： | 1 |
| 10 | Unusual naturally occurring humoral and cellular mutated epitopes of hepatitis B virus in a chronically infected argentine patient with anti-HBs antibodies显示文摘 | Maria L Veronica L Vanesa R | 2006 | J Clini Microbiol2006，44，6： | 1 |
| 11 | Adolescent girls with polycystic ovary syndrome showing different phenotypes have a different metabolic profile associated with increasing androgen levels显示文摘 | FRANCA F DARIA P VERONICA L | 2009 | Fertil Steril2009，92，2： | 1 |
| 12 | Quorum sensing in biofilms-how to destroy the bacterial citadels or their cohesion/power显示文摘 | Veronica L | 2011 | Anaerobe2011，17，6： | 1 |
| 13 | Biolistic transformation of chrysanthemum with the nucleocapsid gene of tomato spotted wilt virus显示文摘 | YEPES L M VERONICA M PANG S Z | 1995 | Plant Cell Reports1995，14，： | 1 |
| 14 | Plant expansins are a complex multigene family with an ancient evolutionary origin显示文摘 | Yi L Catherine P D Veronica O | 2002 | Plant Physiol2002，128，： | 1 |
| 15 | A Systematic Evaluation of the Impact of Stricta and Consort Recommendations on Quality of Reporting for Acupuncture Trials显示文摘 | Stephanie L Prady Stewart J Richmond Veronica M Morton | 2008 | PLoS ONE2008，3，2： | 1 |
| 16 | Electronic and magnetic properties of iron: dinuclear complexes with carboxylate bridges 显示文摘 | Veronica P G Ramon O L Evgenia S | 2004 | Polyhedron2004，23，11： | 1 |
| 17 | Exogenous Tumour necrosis factor-alpha mimics nucleus pulpous-induced neuropathology显示文摘 | Tamaki L Shinichi K Veronica S | 2000 | Spine2000，25，： | 1 |
| 18 | Adolescent girls with polycystic ovary syndrome showing different phenotypes have a different metabolic profile associated with increasing an-drogen levels显示文摘 | Franca F Daria P Veronica L | 2009 | Fertil Steril2009，92，2： | 1 |
| 19 | Adolescent girls with polycystic ovary syndrome showing different phenotypes have a different metabolic profile associated with increasing an drogen levels显示文摘 | Franca F Daria P Veronica L | 2009 | Fertil Steril2009，92，2： | 1 |
| 20 | Antioxidant activity of o-bisphenols: the role of intramolecular hydrogen bonding 显示文摘 | Riccardo A Marco L Veronica M | 2003 | JOrgChem2003，68，13： | 1 |
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