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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 | Prognostically relevant gene signatures of high-grade serous ovarian carcinoma显示文摘 | Verhaak Roel G W Tamayo Pablo Yang Ji-Yeon Hubbard Diana Zhang Hailei Creighton Chad J Fereday Sian Lawrence Michael Carter Scott L Mermel Craig H Kostic Aleksandar D Etemadmoghadam Dariush Saksena Gordon Cibulskis Kristian Duraisamy Sekhar | 2013 | Journal of Clinical Investigation2013，，1： | 2 |
| 3 | Insitu Apoptosis Assay for the Defection of Early Acute Myocardial Infarction显示文摘 | Bardales R H Hailey L S Xie S S | 1996 | Am J Pathol1996，149，3： | 1 |
| 4 | Carbothermal synthesis of SnxSb anode material for secondary lithium -ion battery显示文摘 | Hailei Zhao Ng D H L | 2005 | Journal of Alloys and Compounds2005，395，： | 1 |
| 5 | Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth显示文摘 | H Hailey S J Moore | 2002 | Journal of Medical Genetics2002，39，： | 1 |
| 6 | Characteristics of fetalanticonvulsant syndrome associated autistic disorder显示文摘 | Rasalam AD Hailey H Williams JH | 2005 | Dev MedChild Neurol2005，47，8： | 1 |
| 7 | The role of oxi-dative stress in indium phosphide-induced lung carcinogenesis in rats显示文摘 | Gottsching B C Maronpot R H Hailey J R | 2001 | Toxicological Science2001，64，： | 1 |
| 8 | Investigation of inclusion complex of cilnidipine with hydroxypropy] -β - cyclodextrin 显示文摘 | Liandong H Hailei Z Weihua S | 2012 | Carbohyd Polym2012，90，： | 1 |
| 9 | Densification and mechanical properties of mullite/TiO2-coated B4C composites显示文摘 | HAILEI Z KEISUKE H YASUO M | 2003 | J Eur Ceram Soc2003，23，： | 1 |
| 10 | High yield reproducible rat model recapitulating human Barrett's carcinogenesis显示文摘AIM To efficiently replicate the biology and pathogenesis of human esophageal adenocarcinoma(EAC) using the modified Levrat model of end-to-side esophagojejunostomy. METHODS End-to-side esophagojejunostomy was performed on rats to induce gastroduodenoesophageal reflux to develop EAC. Animals were randomly selected and serially euthanized at 10(n = 6),17(n = 8),24(n = 9),31(n = 6),38(n = 6),and 40(n = 6) wk postoperatively. The esophagi were harvested for downstream histopathology and gene expression. Histological evaluation wascompleted to determine respective rates of carcinogenic development. Quantitative reverse transcriptionpolymerase chain reaction was performed to determine gene expression levels of MUC2,CK19,and CK20,and results were compared to determine significant differences throughout disease progression stages.RESULTS The overall study mortality was 15%. Causes of mortality included anastomotic leak,gastrointestinal hemorrhage,stomach ulcer perforation,respiratory infection secondary to aspiration,and obstruction due to tumor or late anastomotic stricture. 10 wk following surgery,100% of animals presented with esophagitis. Barrett's esophagus(BE) was first observed at 10 wk,and was present in 100% of animals by 17 wk. Dysplasia was confirmed in 87.5% of animals at 17 wk,and increased to 100% by 31 wk. EAC was first observed in 44.4% of animals at 24 wk and increased to 100% by 40 wk. In addition,two animals at 38-40 wk post-surgery had confirmed macro-metastases in the lung/liver and small intestine,respectively. MUC2 gene expression was progressively down-regulated from BE to dysplasia to EAC. Both CK19 and CK20 gene expression significantly increased in a stepwise manner from esophagitis to EAC. CONCLUSION Esophagojejunostomy was successfully replicated in rats with low mortality and a high tumor burden,which may facilitate broader adoption to study EAC development,progression,and therapeutics. | Daisuke Matsui Ashten N Omstead Juliann E Kosovec Yoshihiro Komatsu Emily J Lloyd Hailey Raphael Ronan J Kelly Ali H Zaidi Blair A Jobe | 2017 | World Journal of Gastroenterology2017，23，33： | 0 |
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