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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 | Combustion effects of C6osoot in ammonium nitrate propellants显示文摘 | Greiner B E Frederick R A Maser M D | | 0，，4： | 1 |
| 3 | The loss of Smad3 results in a lower rate of bone formation and osteopenia through dysregulation of osteoblast differentiation and apoptosis 显示文摘 | Borton A 1 Frederick 1 P Datto M B | 2001 | J Bone Miner Res2001，16，10： | 1 |
| 4 | Timing of magnesium supplementation administered through drinking water to improve fresh and stored pork quality显示文摘 | Frederick B R van Heugten E See M T | 2004 | Journal of Animal Science2004，82，5： | 1 |
| 5 | Label-free detection of 16S ribosomal RNA hybridization on reusable DNA arrays using surface plasmon resonance imaging显示文摘 | Nelson B P Liles M R Frederick K B | | 0，，11： | 1 |
| 6 | Synthesis of free and ruthenium coordinated 5,6-diamino-1,10-phenanthroline显示文摘 | FREDERICK M M | 1997 | Tetrahedron Letters1997，38，47： | 1 |
| 7 | A protocol for adaptive transmission in direct-sequence spread-spectrum packet radio networks显示文摘 | FREDERICK J B PURSLEY M B | 2004 | IEEE Transactions on Communications2004，52，8： | 1 |
| 8 | A Protocol for Adap- tive Transmission in Direct-sequence Spread-spectrum Packet Radio Networks 显示文摘 | FREDERICK J B PURSLEY M B | 2004 | IEEE Transactions on Com- munications2004，52，7： | 1 |
| 9 | Smads bind directly to the Jun family of AP-1 transcription factors显示文摘 | Liberati N T Datto M B Frederick J P | | 0，，： | 1 |
| 10 | Purification and partial characterization of a lutein-binding protein from human retina 显示文摘 | Bhosale P Li B Sharifzadeh M Gellermann W Frederick JM Tsuchida K | 2009 | Biochemistry2009，48，22： | 1 |
| 11 | New onset geriatric epilepsy: A randomized study of gabapentin, lamotrigine, and carbamazepine显示文摘 | A J. Rowan R E. Ramsay J F. Collins F Pryor K D. Boardman B M. Uthman M Spitz T Frederick A Towne G S. Carter W Marks J Felicetta M L. Tomyanovich | 2005 | Neurology2005，，11： | 1 |
| 12 | Appli cations of linear and nonlinear time series modeling to heart rate dynamics analysis显示文摘 | David J C Frederick M B Kenneth R L | 1995 | IEEE Transaction on Biomedical Engineering1995，42，4： | 1 |
| 13 | The prevalence and characteristics of fibromyalgia in the general population显示文摘 | Frederick Wolfe M D Kathryn Ross R N Janice Anderson B S | 1995 | Arthritis & Rheumatism1995，38，1： | 1 |
| 14 | Overview ofthe use of natural variability concepts in managing ecological systems显示文摘 | PETER B L PENELOPE M FREDERICK J S | 1999 | Ecological Applications1999，9，4： | 1 |
| 15 | Timing of magnesium supplementation administered through drinking water to improve fresh and stored pork quality显示文摘 | Frederick B R Van Hengte E See M T | 2004 | J Anita Sci2004，82，： | 1 |
| 16 | Induction of the mitochondrial permeability transition in vitro by short-chain carboxylic acids显示文摘 | Palmeira C M Rana M I Frederick C B | 2000 | Biochem Biophys Res Commun2000，272，2： | 1 |
| 17 | Density, thermal expansivity, viscosity and refractive index of tysozyme solutions at crystal growth concentrations 显示文摘 | Fredericks W J Hammonds M C Howard S B et aI | 1994 | J Cryst Growth1994，141，： | 1 |
| 18 | Improved superconducting properties of MgB2显示文摘 | Li S Maple M B | 2001 | Physica C2001，363，： | 1 |
| 19 | Cerebellar vermis involvement in cocaine-related behaviors显示文摘 | Anderson C M Maas L C Frederick B | 2006 | Neuropsychophar macology2006，31，6： | 1 |
| 20 | Controlling odors during grass composting显示文摘 | STUART C B FREDERICK C M Jr | 2002 | BioCycle2002，43，9： | 1 |
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