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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 | Exchange Rate Pass - Through into Import Prices显示文摘 | Campa J M Goldberg L S | 2005 | The Review of Economics and Statistics2005，87，： | 1 |
| 3 | Physiological time-series analysis: What dose regularity quantify? 显示文摘 | PINCUS S M GOLDBERGER A L | 1994 | American Journal of Physiology1994，266，4： | 1 |
| 4 | Structure of small virus-like particles assembled from the L1 protein of human papillomavirus 16 显示文摘 | Chen X S Garcea R L Goldberg I | 2000 | Mol Cell2000，5，3： | 1 |
| 5 | Physiological time series analysis : What does regularity quantify? 显示文摘 | Pincus S M Goldberger A L | 1994 | Am J Physiol1994，266，： | 1 |
| 6 | Exaggerated heart rate oscillations during two meditation techniques 显示文摘 | Peng C-K and Mietus J E and Liu Y and Khalsa G and Douglas P S and Benson H and Goldberger A L | 1999 | Int J Cardiol:1999，70，： | 1 |
| 7 | Linguistic features of noneoding DNA sequences 显示文摘 | Mantegna R N Buldyrev S V Goldberger A L | 1994 | Physical Review Let- ters1994，73，23： | 1 |
| 8 | Glucocortieoids activate the ATP ubiquitin-dependent proteolytic system in skeletal muscle during fasting显示文摘 | Wing S S Goldberg A L | 1993 | Am J Physiol1993，264，4： | 1 |
| 9 | Preparation of an amino acid intermediate for the dipeptidyl peptidase IV inhibitor, saxagliptin, using a modified phenylalanine dehydrogenase 显示文摘 | HANSON R L GOLDBERG S L BRZOZOWSKI D B | 2007 | Adv Synth Catal2007，349，89： | 1 |
| 10 | Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis 显示文摘 | DORMAN S E JOHNSON J L GOLDBERG S | 2009 | Am J Respir Crit Care Med2009，180，3： | 1 |
| 11 | Fractal landscape analysis of DNA walks 显示文摘 | Peng C K Buldyrev S V Goldberger A L etc | 1992 | Physica A1992，191，14： | 1 |
| 12 | Scaling behavlour of heartbeat intervals obtained by wavelet-based time-series analysis显示文摘 | Inanov P C h and Rosenblum M G and Peng C-K and Mietus J and Havlin S and Stanley H E and Goldberger A L | 1996 | Nature1996，383，： | 1 |
| 13 | Suppression of Human Melanoma Metastasis by the Metastasis Suppressor Gene,BRMS1显示文摘 | Shevde L A Samant R S Goldberg S F | 2002 | Exp Cell Res2002，273，2： | 1 |
| 14 | Structure of small virus- like particles assembled from the L1 protein of human papillomavirus 16显示文摘 | Chen X S Garcea R L Goldberg I | 2000 | Mol Cell2000，5，3： | 1 |
| 15 | Proteasome inhibition leads to a heat-shock response,induction of endoplasmic reticulum chaperones,and thermotolerance显示文摘 | Bush K T Goldberg A L Nigam S K | 1997 | J Biol Chem1997，272，14： | 1 |
| 16 | An immobilized two-enzyme system and its use in the continuous production of high conversion maltose containing corn syrups显示文摘 | HAUSSER A G GOLDBERG B S MERTENS J L | 1983 | Biotechnology and Bioengineering1983，25，2： | 1 |
| 17 | Physiological time-se-ries analysis:What does regularity quantify显示文摘 | Pincus S M Goldberger A L | 1994 | The American Physiological Society1994，266，42： | 1 |
| 18 | Display rules versus display au- tonomy: emotion regulation, emotional exhaustion, and task performance in a call center simulation 显示文摘 | Goldberg L S Grandey A A | 2007 | Journal of occu- pational health psychology2007，12，3： | 1 |
| 19 | Physiological time-series analysis:what does regularity quantify?显示文摘 | Pincus S M Goldberger A L | 1994 | American Journal of Physiology1994，266，： | 1 |
| 20 | Suppression of human melanoma metastasis by the metastasis suppressor gene, BRMS1 显示文摘 | SHEVDE L A SAMANT R S GOLDBERG S F | 2002 | Exp Cell Res2002，273，： | 1 |
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