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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 | Celiac disease:Management of persistent symptoms in patients on a gluten-free diet显示文摘AIM:To investigate all patients referred to our center with non-responsive celiac disease (NRCD),to establish a cause for their continued symptoms.METHODS:We assessed all patients referred to our center with non-responsive celiac disease over an 18-mo period.These individuals were investigated to establish the eitiology of their continued symptoms.The patients were first seen in clinic where a thorough history and examination were performed with routine blood work including tissue transglutaminase antibody measurement.They were also referred to a specialist gastroenterology dietician to try to identift any lapses in the diet and sources of hidden gluten ingestion.A repeat small intestinal biopsy was also performed and compared to biopsies from the referring hospital where possible.Colonoscopy,lactulose hydrogen breath testing,pancreolauryl testing and computed tomography scan of the abdomen were undertaken if the symptoms persisted.Their clinical progress was followed over a minimum of 2 years.RESULTS:One hundred and twelve consecutive patients were referred with NRCD.Twelve were found not to have celiac disease (CD).Of the remaining 100 patients,45% were not adequately adhering to a strict gluten-free diet,with 24 (53%) found to be inadvertently ingesting gluten,and 21 (47%) admitting noncompliance.Microscopic colitis was diagnosed in 12% and small bowel bacterial overgrowth in 9%.Refractory CD was diagnosed in 9%.Three of these were diagnosed with intestinal lymphoma.After 2 years,78 patients remained well,eight had continuing symptoms,and four had died.CONCLUSION:In individuals with NRCD,a remediable cause can be found in 90%:with continued gluten ingestion as the leading cause.We propose an algorithm for investigation. | David H Dewar Suzanne C Donnelly Simon D McLaughlin Matthew W Johnson H Julia Ellis Paul J Ciclitira | 2012 | World Journal of Gastroenterology2012，18，12： | 2 |
| 3 | Growth behaviour of a spore forming probiotic strain in the gastrointestinal tract of broilers chicken and piglets显示文摘 | Anke J W Vanien 0 Simon | 2001 | Architech Animal Nutrition2001，，54： | 1 |
| 4 | P0tential of low- molecular chitosan as a DNAdelivery system : biocompatility, bo- dydistribution and ability to complex and protect DNA显示文摘 | Simon C W R Hanno V J K Ruth D | 1999 | Inter- national Journal of Pharrnacentics1999，178，： | 1 |
| 5 | Supercritical fluid extraction of essential oil components from lemon-scented botanicals显示文摘 | Rozzi N L Phippen W Simon J E | 2002 | Lebensm Wiss U Technol2002，35，： | 1 |
| 6 | 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 |
| 7 | 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 |
| 8 | Residual magnetic field sensing for stress measurement 显示文摘 | Wilson J W Tian Gui Yun Barrans Simon | 2007 | Sensors and Actuators2007，，135： | 1 |
| 9 | Serum and CSF concentrations of brain specific proteins in hydrocephalus显示文摘 | Beems T Simons K S van Geel W J A | 2003 | Acta Neurochirurgica2003，145，1： | 1 |
| 10 | Entanglement Purification {or Quantum Cornmu-nication 显示文摘 | PAN J W SIMON C BRUKNER 12 | 2001 | Nature2001，410，： | 1 |
| 11 | 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 |
| 12 | Polarization Entanglement Purification using Spatial Entanglement 显示文摘 | SIMON C PAN J W | 2002 | Phys Rev Lett2002，89，25： | 1 |
| 13 | Mathematical modeling of the regulation of caspase-3 activation and degradation显示文摘 | STUCKI J W SIMON H U | 2005 | J Theor Biol2005，234，1： | 1 |
| 14 | Quantum simulation of antiferromagnetic spin chains in an optical lattice 显示文摘 | Simon J Bakr W S Ma R | 2011 | Nature(London)2011，472，： | 1 |
| 15 | Expanding the potentialfor waste polyvinyl alcohol 显示文摘 | ANDREW J H VITALY L B SIMON W B | 2009 | Green Chemistry2009，11，： | 1 |
| 16 | Pathogen elicitor-induced changes in the maize extracellular matrix proteome显示文摘 | CHIVASA S SIMON W J YU X L | 2005 | Proteomics2005，5，： | 1 |
| 17 | The effect of light on the senescence of detached cucumber cotyledons显示文摘 | Lewington R J Simon E W | 1969 | J Exp Bot1969，20，： | 1 |
| 18 | A new method for the nonlinear transformation of means and covarianees in filters and estimators显示文摘 | SIMON J JEFFREY U HUGH F D W | 2000 | IEEE Trans- action on Automatic Control2000，45，3： | 1 |
| 19 | Microwave abalation: principles and applications 显示文摘 | Simon C J Dupuy D E Mayo-Smith W W | 2005 | Radiographies2005，25，1： | 1 |
| 20 | 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 |
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