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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 | Cusp gun TE21 second-harmonic Ka-band gyro-TWT amplifier显示文摘 | HARRIET S B MCDERMOTT D B GALLAGHER DA | 2002 | IEEE Trans Plasma Science2002，30，3： | 1 |
| 3 | Cusp gun TE21 second-harmonic Ka-band gyro-TWT amplifier显示文摘 | Harriet S B McDermott D B Gallagher D A | 2002 | IEEE Trans on Plasma Science2002，30，3： | 1 |
| 4 | Incidence and Survival Rates for Female Malignant Germ Cell Tumors 显示文摘 | Harriet OS Marianne B Claire FV | 2006 | Obstet Gynecol2006，107，5： | 1 |
| 5 | Gatifloxacin显示文摘 | Caroline M P Julia A B Harriet M L | 1999 | Drugs1999，58，4： | 1 |
| 6 | The Essence of Humour and Its Effects and Functions:A Qualitative Study显示文摘 | Hennny O Harriet B | 2002 | Journal of Nursing Management2002，10，： | 1 |
| 7 | Cisatracurium Besilate显示文摘 | Harriet M B Diana F | 1997 | Drugs1997，53，5： | 1 |
| 8 | Detection of a group 2 coronavirus in dogs with canine infectious respiratory disease 显示文摘 | Erles K Toomey C Harriet W B | 2003 | Virology2003，310，： | 1 |
| 9 | Cusp gun TE21 second-harmonic Ka-band gyro TWT amplifier显示文摘 | Harriet S B Mcdermott D B Gallagherda D A | 2002 | IEEE Trans on Plasma Science2002，30，3： | 1 |
| 10 | Gatifloxacin 显示文摘 | CAROLINE M P JULIA A B B HARRIET M L | 1999 | Drug1999，58，4： | 1 |
| 11 | Theaflavin-3,3-digallate,a component of black tea:An inducer of oxidative stress and apoptosis显示文摘 | SCHUCK ALYSSA G AUSUBEL MIRIAM B ZUCKERBRAUN HARRIET L | 2008 | Toxicology in Vitro2008，22，3： | 1 |
| 12 | The X-linked inhibitor of apoptosis protein (XIAP) is up-regulated in metastatic melanoma, and XIAP cleavage by phenoxodiol is associated with carboplatin sensitization显示文摘 | Harriet M Kluger Mary MMc Carthy Ayesha B Alvero | 2007 | J Transt Med2007，5，： | 1 |
| 13 | Incidence and Survival Rates for Female Malignant Germ Cell Tumors 显示文摘 | Harriet OS Marianne B Claire FV | 2006 | Obstet Gynecol2006，107，5： | 1 |
| 14 | Does Preoperative Anxiety Level PredictPostoperative Pain 显示文摘 | Felicia V Harriet W Gerry B | 2007 | Association of Operating Room Nurses AORNJournal2007，85，3： | 1 |
| 15 | Theaflavin-3,3'-digallate,a component of black tea:an inducer of oxidative stress and apoptosis显示文摘 | Alyssa a G Schuck Miriam B Ausubel Harriet L Zuckerbraun | 2008 | Toxicology in Vitro2008，22，3： | 1 |
| 16 | Employment Schedules among Dual-earner Spouses and the Division of Household Labor by Gender显示文摘 | Presser Harriet B | 1994 | American Sociological Review1994，，59： | 1 |
| 17 | Incidence and Survival Rates for Female Malignant Germ Cell Tumors 显示文摘 | Harriet OS Marianne B Claire FV | 2006 | Obstet Gynecol2006，107，5： | 1 |
| 18 | Circulating hormones and breast cancer risk in premenopansal women : A randomized trial of low - dose tamoxifen and fenretinide 显示文摘 | Harriet J Bernardo B Sara G | 2013 | Breast Cancer Res Treat2013，142，： | 1 |
| 19 | Detection of a group 2 coronavirus in dogs with canine infectious respiratory disease显示文摘 | Erles K Toomey C Harriet W B etal | 2003 | Virology2003，310，： | 1 |
| 20 | Development of a quantitative real-time PCR for the detection of canine respiratory coronavirus显示文摘 | Judy AM Harriet B Kai-Biu Shiu | 2009 | Journal of Virological Methods2009，155，： | 1 |
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