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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 | Randomised trial of flush saphenofemoral ligation for primary great saphenous varicose veins 显示文摘 | WINTERBORN R J FOY C HEATHER B P | 2008 | Eur J Vasc Endovasc Surg2008，36，4： | 1 |
| 3 | School-based intervention for adolescents with social anxiety disorder:Result of a controlled study显示文摘 | Carrie Masia-Warner Rachel G Klein Heather C Dent | 2005 | Journal of Abnormal Child Psychology2005，33，6： | 1 |
| 4 | Drought is normal: the socio-technical evolution of drought and water demand in England and Wales, 1893-2006 显示文摘 | Vanessa T Heather C Will M | 2009 | Journal of Historical Geography2009，35，3： | 1 |
| 5 | Silica in plants: biological,biochemical and chemical studies显示文摘 | HEATHER A C CAROLE C P | 2007 | Annals of Botany2007，100，7： | 1 |
| 6 | Unintended consequences of regulating drinking water in rural Canadian communities : Examples from Atlantic Canada 显示文摘 | Megan K Heather C Graham A G | 2011 | Health2011，17，： | 1 |
| 7 | Fatty acid transporterlevels and palmitate oxidation rate correlate with ejection fraction inthe infarcted rat heart显示文摘 | Heather L C Cole M A Lygate C A | 2006 | Cardiovasc Res2006，72，3： | 1 |
| 8 | Rethinking Individualism and Col- lectivism: Evaluation of Theoretical Assumptions and Meta- Analyses 显示文摘 | OYSERMAN D HEATHER M C KEM- MELMEIR M | 2002 | Psychological Bulletin2002，128，1： | 1 |
| 9 | Governing the Carbon Offset Market显示文摘 | Heather C L | 2010 | WIREs Climate Change2010，，1： | 1 |
| 10 | Assessing the work environment for creativity显示文摘 | Amabile T M Regina C Heather C | 1996 | Academy of Management Journal1996，39，5： | 1 |
| 11 | Assessing the work environment for creativity显示文摘 | Amabile T M Regina C Heather C | 1996 | Journa1996，39，5： | 1 |
| 12 | Adult neurogenesis pro- duces a large pool of new granule cells in the dentate gyrus显示文摘 | Heather A C Renald D G | 2001 | J Comp Neurol2001，435，4： | 1 |
| 13 | Reactive oxidants and myeloperoxidase and their involvement in neutrophil extracellular traps显示文摘 | Heather Parker Christine C Winterboum | 2013 | Frontiers in Immunology2013，3，424： | 1 |
| 14 | Silica in plants: biological,biochemical and chemical studies显示文摘 | Heather A Currie Carole C | 2007 | Annals of Botany2007，100，： | 1 |
| 15 | Developing Measures of Teachers’Mathematics Knowledge for Teaching显示文摘 | Heather C Hill Stephen G Schilling Deborah Loewenberg Ball | 2013 | The Elementary School Journal2013，，1： | 1 |
| 16 | Diabetic ketoacidosis:a complication of type 2 diabetes in Canadian aboriginal youth显示文摘 | Elizabeth A C Heather J | 2000 | Diabetes Care2000，23，8： | 1 |
| 17 | Transient DI dopamine receptor expression on prefrontal cortex projection neurons: relationship to enhanced motivational salience of drug cues in adolescence 显示文摘 | Heather C Brenhouse Kai C | 2008 | Neuroscience2008，28，： | 1 |
| 18 | Rubber toughening of plastics 显示文摘 | Bucknall C B Heather P S Lazzeri A | 1989 | J Mater Sci1989，24，7： | 1 |
| 19 | Governing the carbon offset market显示文摘 | Lovel Heather C | 2010 | Wiley Interdisciplinary Reviews-Climate Change2010，1，3： | 1 |
| 20 | The effetcs of oral-motor exercises on swallowing in children: an evidence-based systematic re- view显示文摘 | Joan A Heather C Cathy L | 2010 | Developmental Medicine & Child Neurology2010，52，： | 1 |
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