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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 | Tree allometry and improved estimation of carbon stocks and balance in tropical forests显示文摘 | Chave J Andalo C Brown S Cairns M A Chambers J Q Eamus D Folster H Fromard F Higuchi N Kira T Lescure J P Nelson B W Ogawa H Puig H Riera B Yamakura T | | 0，，： | 1 |
| 3 | Seeing I to I : A Pathway to Interpersonal Connectedness 显示文摘 | Pinel Elizabeth C Long Anson E Landau Mar J Alexander Kira Pyszczynski Tom | 2004 | Journal of Personality and Social Psychology2004，90，2： | 1 |
| 4 | Seeing I to I : A Pathway to Interpersonal Connectedness 显示文摘 | Pinel Elizabeth C Long Anson E Landau Mar J Alexander Kira Pyszezynski Tom | 2004 | Journal of Personality and Social Psychology2004，90，2： | 1 |
| 5 | The first stable cyclotrisilene显示文摘 | Iwamoto T Kabuto C Kira M | 1999 | J Am Chem Soc1999，121，： | 1 |
| 6 | Proposed modifications to the Mc-Donald criteria for use in Asia显示文摘 | Chong H Kira J Tsai C | 2009 | Mult Scler2009，15，： | 1 |
| 7 | The first stable cyclotrisilene显示文摘 | Kabuto C Kira M | 1999 | J Am Chem Soc1999，121，4： | 1 |
| 8 | Effects of repeated extracorporeal shock wave on kidney apoptosis of normal and diabetic rat显示文摘 | Kira V M Fagundes D J Bandeira C O | 2008 | International Braz J Urol2008，34，1： | 1 |
| 9 | Innovation,Technological Regimes and Organizational Selection in Industry Evolution:a ‘ History Friendly Model’ ofthe DRAM industry 显示文摘 | Kira C Lee K | 2003 | Industrial and Corporate Change2003，12，： | 1 |
| 10 | Caudal pi(lural Suftntanil anti I)upivacaine decreases stress rtspt)nse in paediatric cardiac surgcly 显示文摘 | Sendasgupta C Makhija N Kira U | 2009 | Ann Card Anaesth2009，12，1： | 1 |
| 11 | A hybrid metaheuristic algorithm for the vehicle routing problem with simultaneous deliv ery and pick-up service显示文摘 | ZACHARIADIS E E TARANTILIS C D KIRA NOUDIS C T | 2009 | Expert Systems with Ap- plications2009，36，10： | 1 |
| 12 | Identification and characterization of a salt stress inducible zinc finger protein from Festuca arundinacea显示文摘 | Ruth C M Kira G James C B | 2012 | BMC Research Notes2012，5，： | 1 |
| 13 | Selective Carbon-Bromine Bond Fission Induced by Non-Resonant Two-Photon (NRTP) Exci- tation of trans-4-Bromostilbene显示文摘 | Miyazawa T Liu C Kira M | 1997 | Chem Lett1997，26，5： | 1 |
| 14 | Comparison of partial di- gestion procedures for determination of Ca, Cr, Cu, Fe, K, Mg, Mn, Na,P and Zn in milk by inductively coupled plasma-optical emission spectrometry 显示文摘 | Kira C S Maio F D Maihara V A | 2004 | Journal of AOAC International2004，87，1： | 1 |
| 15 | A tabu search algorithm for parallel machine total tardiness problem显示文摘 | BILGE (U) KIRA(C) F KURTULAN M PEKG(U)N P | | 0，，03： | 1 |
| 16 | The first stable cyclotrisilene显示文摘 | Kabuto C Kira M | 1999 | J Am Chem Soc1999，121，4： | 1 |
| 17 | Effect of pentylenetetrazole and sound stimulation induced single and repeated convulsive seizures on the MDA, GSH and NO levels, and SOD activities in rat liver and kidney tissues 显示文摘 | Dillioglugil MO Kira HM Demira C | 2010 | Brain Research Bulletin2010，83，2： | 1 |
| 18 | Abdominal aortic aneurysm size regression after endovascular repair is endograft dependent显示文摘 | DANIEL J B KIRA C MARK C W | 2003 | J of Vasc Surg2003，37，4： | 1 |
| 19 | CT of rib lesions显示文摘 | Benjamin DL Kambiz M Kira C | 2009 | AJR2009，193，1： | 1 |
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