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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 | A randomized controlled trial of sequentially bilateral prefrontal cortex repetitive transcranial magnetic stimulation in the treatment of negative symptoms in schizophrenia显示文摘 | Barr M S Farzan F Tran L C | 2012 | Brain Stimul2012，5，3： | 1 |
| 3 | Robust analysis of the yeast proteome under 50 kDa by molecular-massbased fractionation and top-down mass spectrometry显示文摘 | Kellie J F Catherman A D Durbin K R Tran J C Tipton J D Norris J L Witkowski C E 2nd Thomas P M Kelleher N L | | 0，，01： | 1 |
| 4 | Identification of galactose-a-1, 3-galactose in the gastrointestinal tract of the tick Ixodes ricinus; possible relationship with red meat allergy 显示文摘 | Hamsten C Starkhammar M Tran TA | 2013 | Allergy2013，68，： | 1 |
| 5 | Two-phase pressure drop of refrigerants during flow boiling in small channels:an experimental investigation and correlation development显示文摘 | Tran T N Chyu M C Wambsganss M W | 2000 | Int J Multiphase Flow2000，26，： | 1 |
| 6 | Near-Infrared Spectroscopic Investigation of Inclusion Complexes Between Cyclodextrinsand Aromatic Compounds 显示文摘 | Politi M J’Tran C D Gao G H | 1995 | J Phys Chem1995，99，14： | 1 |
| 7 | Regulation of CCN2/connective tissue growth factor expression in the nucleus pulposus of the intervertebral disc显示文摘 | Tran C M Markova D Smith H E | 2010 | Arthritis Rheum2010，62，7： | 1 |
| 8 | Effects of non-structural proteins NS1 and NS2 of human respiratory syncytial virus on interferon regulatory factor 3, NFkappaB, and proinflammatory eytokines 显示文摘 | Spann K M Tran K C Collins P L | 2005 | J Virol2005，79，9： | 1 |
| 9 | Laboratory diagnosis and surveillance of human respiratory viruses by PCR in Victoria, Australia, 2002-2003 显示文摘 | Druce J Tran T Kelly H Kaye M Chibo D Kostecki R Amiri A Catton M Birch C | 2005 | J Med Virol2005，75，1： | 1 |
| 10 | 显示文摘 | C Yanar J M K Wiezorek V Radmilovic W A Soffa Metall Mater Trans | 2002 | 33A :24132002，33，： | 1 |
| 11 | Suppression of the induction of alpha, beta, and lambda interferons by the NS1 and NS2 proteins of human respiratory syncytial virus in human epithelial cells and macrophages 显示文摘 | Spann K M Tran K C Chi B | 2004 | J Virol2004，78，8： | 1 |
| 12 | Investigations into Glyphosate-resistant Horseweed ( Conyza canadensis ) : Retention, Uptake, Translocation, and Metabolism 显示文摘 | FENG P C C TRAN M CHIU T | 2004 | Weed Sci2004，52，： | 1 |
| 13 | Data reduction of room tests for zone model validation 显示文摘 | Janssens M L Tran H C | 1992 | Journal of Fire Sci- ence1992，10，6： | 1 |
| 14 | Methods of fluid-structure coupling in frequency and time domains using linearized aerodynamics for turbo machinery显示文摘 | Tran D M Liauzun C Labaste C | 2003 | Journal of Fluids and Structures2003，17，8： | 1 |
| 15 | Chiral ionic liquids for enantioseparation of pharmaceutical products by capillary electrophoresis显示文摘 | Tran C Irena M | 2008 | J Chromatography A2008，1204，2： | 1 |
| 16 | Quality of life and home enteral feed- ing:a French prospective study in patients with head and neck or oe- sophageal cancer显示文摘 | Roberge C Tran M Massoud C | 2000 | Br J Cancer2000，82，： | 1 |
| 17 | Molecular modelling of the specific interactions involved in the amylose complexation by fatty acids显示文摘 | GODET M C TRAN V DELAGE M M | 1993 | Int J Biol Macromol1993，15，： | 1 |
| 18 | Public perception of development issues:impact of water pollution on a small coastal community显示文摘 | Tran K C Euan J Isla M L | 2002 | Ocean & Coastal Management2002，45，6： | 1 |
| 19 | The virtual reality simulator dV-Trainer()is a valid assessment tool for robotic surgical skills显示文摘 | Perrenot C Perez M Tran N | | 0，，09： | 1 |
| 20 | Relative contribution of core and skin temperatures to thermal comfort in humans 显示文摘 | Bulcao C F Frank S M Raja S N Tran K M Goldstein D S | 2000 | Journal of Thermal Biology2000，25，12： | 1 |
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