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| 1 | 帕博利珠单抗单用或与放疗联用治疗转移性非小细胞肺癌:两个随机试验的汇总分析显示文摘背景放疗可以提高整个机体对免疫治疗的应答。在Ⅱ期PEMBRO-RT研究和Ⅰ/Ⅱ期MDACC研究中,患有转移性非小细胞肺癌(NSCLC)的患者被随机分配入组,接受免疫治疗(帕博利珠单抗)+放疗联合疗法,或免疫治疗单一疗法。当上述2个研究单独分析时,联合疗法组显示出潜在获益。由于每个研究的样本量较小,缓解率和结局并未显示出统计学意义,然而却有显著的临床获益。因此,本研究进行汇总分析,来判断放疗是否会改善转移性NSCLC患者的免疫治疗应答。方法PEMBRO-RT和MDACC研究纳入标准:患者年龄≥18岁,患有转移性NSCLC,且有≥1处未经放疗照射的病灶,以便进行射野外应答监测。PEMBRO-RT研究纳入曾接受过化疗患者,MDACC研究纳入曾接受过治疗或新诊断患者。2个研究中的患者均未接受过免疫治疗。在PEMBRO-RT研究中患者被等比例随机分配入组,并根据吸烟状态进行分层(分为<10年组和≥10年组)。MDACC研究的患者根据放疗计划可行性被等比例随机分配入2个受试组。由于联合治疗组的干预本质,每个研究中的放疗均不适用盲法。在2个研究中,不论是否进行放疗,均静脉滴入帕博利珠单抗(每3周200 mg)。在PEMBRO-RT研究中,在放疗(24 Gy 3次分割照射)结束后1周给予第1剂帕博利珠单抗。在MDACC研究中,在第1次放疗(50 Gy 4次分割照射或45 Gy 15次分割照射)同时给予帕博利珠单抗。仅检测未经照射病灶的应答。本研究的终点为最佳射野外(远隔)应答率(ARR)、最佳射野外疾病控制率(ACR)、12周时ARR、12周时ACR、无进展生存期(PFS)和总生存期(OS)。2个研究的意向治疗(ITT)人群均纳入分析。PEMBRO-RT研究(NCT02492568)和MDACC研究(NCT02444741)均在ClinicalTrials.gov上注册。发现纳入148例患者,76例接受帕博利珠单抗治疗,72例接受帕博利珠单抗+放疗治疗。所有患者随访时间中位数为33个月[四分位距(IQR):32.4~33.6]。148例患者中124例(84%)组织学特征为非鳞癌,111例(75%)患者曾经接受过化疗。组间没有基线特征差异,包括PD-L1表达状态和转移灶体积。最常见的照射部位为肺转移灶(39%,28/72)、胸腔内淋巴结(21%,15/72)和非原发灶(17%,12/72)。帕博利珠单抗组和联合治疗组的最佳ARR分别为19.7%(15/76)和41.7%(30/72),OR=2.96,95%CI:1.42~6.20,P=0.0039;最佳ACR分别为43.4%(33/76)和65.3%(47/72),OR=2.51,95%CI:1.28~4.91,P=0.0071;PFS中位数分别为4.4(IQR:2.9~5.9)和9.0个月(IQR:6.8~11.2),HR=0.67,95%CI:0.45~0.99,P=0.045;OS中位数分别为8.7(IQR:6.4~11.0)和19.2个月(IQR:14.6~23.8),OR=0.67,95%CI:0.54~0.84,P=0.0004。在汇总分析中没有发现新的安全问题。解读帕博利珠单抗免疫疗法+放疗显著提高转移性NSCLC患者的应答和改善治疗结局。这些结果需要在三期临床试验中进行验证。 | 陈大卫(翻译) 于金明(校对) Willemijn S M E Theelen Vivek Verma Brian P Hobbs Heike M U Peulen Joachim G J V Aerts Idris Bahce Anna Larissa N Niemeijer Joe Y Chang Patricia M de Groot Quynh-Nhu Nguyen Nathan I Comeaux George R Simon Ferdinandos Skoulidis Steven H Lin Kewen He Roshal Patel John Heymach Paul Baas James W Welsh | 2021 | 中华肿瘤防治杂志2021，28，24： | 49 |
| 2 | Machine learning models compared to existing criteria for noninvasive prediction of endoscopic retrograde cholangiopancreatography-confirmed choledocholithiasis显示文摘Background and aims:Noninvasive predictors of choledocholithiasis have generally exhibited marginal performance characteristics.We aimed to identify noninvasive independent predictors of endoscopic retrograde cholangiopancreatography(ERCP)-confirmed choledocholithiasis and accordingly developed predictive machine learning models(MLMs).Methods:Clinical data of consecutive patients undergoing first-ever ERCP for suspected chol-edocholithiasis from 2015 to 2019 were abstracted from a prospectively-maintained database.Multiple logistic regression was used to identify predictors of ERCP-confirmed choledocholithiasis.MLMs were then trained to predict ERCP-confirmed choledocholithiasis using pre-ERCP ultrasound(US)imaging only as well as using all available noninvasive imaging(US,computed tomography,and/or magnetic reso-nance cholangiopancreatography).The diagnostic performance of American Society for Gastrointestinal Endoscopy(ASGE)“high-likelihood”criteria was compared to MLMs.Results:We identified 270 patients(mean age 46 years,62.2%female,73.7%Hispanic/Latino,59%with noninvasive imaging positive for choledocholithiasis)with native papilla who underwent ERCP for suspected choledocholithiasis,of whom 230(85.2%)were found to have ERCP-confirmed chol-edocholithiasis.Logistic regression identified choledocholithiasis on noninvasive imaging(odds ratio(OR)¼3.045,P¼0.004)and common bile duct(CBD)diameter on noninvasive imaging(OR¼1.157,P¼0.011)as predictors of ERCP-confirmed choledocholithiasis.Among the various MLMs trained,the random forest-based MLM performed best;sensitivity was 61.4%and 77.3%and specificity was 100%and 75.0%,using US-only and using all available imaging,respectively.ASGE high-likelihood criteria demonstrated sensitivity of 90.9%and specificity of 25.0%;using cut-points achieving this specificity,MLMs achieved sensitivity up to 97.7%.Conclusions:MLMs using age,sex,race/ethnicity,presence of diabetes,fever,body mass index(BMI),total bilirubin,maximum CBD diameter,and choledocholithiasis on pre-ERCP noninvasive imaging predict ERCP-confirmed choledocholithiasis with good sensitivity and specificity and outperform the ASGE criteria for patients with suspected choledocholithiasis. | Camellia Dalai John M Azizian Harry Trieu Anand Rajan Formosa C Chen Tien Dong Simon W Beaven James H.Tabibian | 2021 | Liver Research2021，5，4： | 3 |
| 3 | Generalized selection combining based on the log-likelihood ratio显示文摘 | Kim S W Kim Y G and Simon M K | 2004 | IEEE Transactions on Communications2004，52，4： | 1 |
| 4 | The measurement and determinants of brand equity: a financial ap- proach显示文摘 | Simon C J Sullivan M W | 1993 | Marketing Science1993，，： | 1 |
| 5 | Examining the motivational impact of intrinsic versus extrinsic goal framing and autonomy supportive versus internally controlling communication style on early adolescents' academic achievement显示文摘 | Vansteenkiste M Simons J Lens W | 2005 | Child Development2005，76，： | 1 |
| 6 | The phase II urokinase-streptokinase pulmonary embolism trial: a national cooperative study显示文摘 | Sasahra A A Bell W R Simon T L Stengle J M Sherry S | 1975 | Thromb Diath Haemorrh1975，33，： | 1 |
| 7 | The potassium channel modulator flupir- tine shifts the frequencyresponse function of hippocampal synapses to favor LTD in mice显示文摘 | Azad SC Eder M Simon W | 2004 | Neurosci Lett2004，370，23： | 1 |
| 8 | Flowering, seeding production, and the genesis of garlic breeding 显示文摘 | Simon W P Jenderek M M | 2003 | Plant Breeding Reviews2003，23，11： | 1 |
| 9 | Stabilization of wild-type p53 by hypoxia-inducible factor 1α显示文摘 | KANEKAL M SIMON M C | 1998 | Nature1998，392，6674： | 1 |
| 10 | Stabilization of wild-type p53 by hypoxia-indueible factor 1α显示文摘 | An W G Kanekal M Simon M C | 1998 | Nature1998，392，6674： | 1 |
| 11 | A QTL affecting milk yield and composition maps to bovine chromosome 20: A confirmation 显示文摘 | Arranz J J Coppieters W Berzi P Cambisano N Grisart B Karim L Marcq F Moreau L Mezer C Riquet J Simon P Vanmanshoven P Wagenaar D and Georges M | 1998 | Animal Genetics1998，29，： | 1 |
| 12 | Measurement of THM and precursor concentrations revisited: the effect of bromide ion 显示文摘 | Simons J M Kranser S W Simms L A | 1993 | Journal of American Water Works Association1993，85，： | 1 |
| 13 | The synthesis and structure-activity relationship of substituted N-phenyl anthranilic acid analogs as amy- loid aggregation inhibitors 显示文摘 | SIMONS L J CAPRATHE B W CALLAHAN M | 2009 | Bioorg Med Chem Lett2009，19，3： | 1 |
| 14 | Evaluation of Passenger Rail Vehicle Crashworthiness 显示文摘 | Kirkpatrick S W Schroeder M Simons J W | 2001 | International Journal of Crashworthiness2001，6，1： | 1 |
| 15 | A comparison between the effects of acetaminophen and celecoxib on bone fracture healing in rats 显示文摘 | Bergenstock M Min W Simon A M el al | 2005 | Orthop Trauma2005，19，10： | 1 |
| 16 | Improvement of phosphorus availability by microbial phytase in broilers and pigs显示文摘 | Simons P C M Versteegh H A J Jongloed A W | 1990 | British Journal Nutrition1990，64，： | 1 |
| 17 | Receptors of vascular endothelial growth factor/vascular permeability factor (VEGF/VPF) in fetal and adult human kidney:localization and VEGF binding sites显示文摘 | SIMON M ROCKI W HORNIG C | 1998 | J Am Soc Nephrol1998，9，6： | 1 |
| 18 | Content-based image retrieval at the end of the early years显示文摘 | MARCE W SIMONE S | 2000 | IEEE Transactions on Pattern Analysis and Machine Intelligence2000，22，12： | 1 |
| 19 | Motivating, Learning, Performance, and Persistence:the Synergistic Effects of Intrinsic goal Contents and Autonomy - Supportive Contexts 显示文摘 | Vansteenkiste M Simons J Lens W | 2004 | Jotlmal of Personality and Social Psychology2004，87，2： | 1 |
| 20 | Do Measures of Investor Sentiment Predict Returns显示文摘 | Neal Robert Simon M W | 1998 | Journal of Financial and Quantitative Analysis1998，33，4： | 1 |
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