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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 | Esophageal tissue engineering:A new approach for esophageal replacement显示文摘A number of congenital and acquired disorders require esophageal tissue replacement.Various surgical techniques,such as gastric and colonic interposition,are standards of treatment,but frequently complicated by stenosis and other problems.Regenerative medicine approaches facilitate the use of biological constructs to replace or regenerate normal tissue function.We review the literature of esophageal tissue engineering,discuss its implications,compare the methodologies that have been employed and suggest possible directions for the future.Medline,Embase,the Cochrane Library,National Research Register and ClinicalTrials.gov databases were searched with the following search terms:stem cell and esophagus,esophageal replacement,esophageal tissue engineering,esophageal substitution.Reference lists of papers identified were also examined and experts in this field contacted for further information.All full-text articles in English of all potentially relevant abstracts were reviewed.Tissue engineering has involved acellular scaffolds that were either transplanted with the aim of being repopulated by host cells or seeded prior to transplantation.When acellular scaffolds were used to replace patch and short tubular defects they allowed epithelial and partial muscular migration whereas when employed for long tubular defects the results were poor leading to an increased rate of stenosis and mortality.Stenting has been shown as an effective means to reduce stenotic changes and promote cell migration,whilst omental wrapping to induce vascularization of the construct has an uncertain benefit.Decellularized matrices have been recently suggested as the optimal choice for scaffolds,but smart polymers that will incorporate signalling to promote cell-scaffold interaction may provide a more reproducible and available solution.Results in animal models that have used seeded scaffolds strongly suggest that seeding of both muscle and epithelial cells on scaffolds prior to implantation is a prerequisite for complete esophageal replacement.Novel approaches need to be designed to allow for peristalsis and vascularization in the engineered esophagus.Although esophageal tissue engineering potentially offers a real alternative to conventional treatments for severe esophageal disease,important barriers remain that need to be addressed. | Giorgia Totonelli Panagiotis Maghsoudlou Jonathan M Fishman Giuseppe Orlando Tahera Ansari Paul Sibbons Martin A Birchall Agostino Pierro Simon Eaton Paolo De Coppi | 2012 | World Journal of Gastroenterology2012，18，47： | 5 |
| 3 | Endoscopic ultrasonography in the evaluation of leiomyoma and extramucosal cysts of the esophagus显示文摘 | Massari M De Simone M Cioffi U | 1998 | Hepatogastroenterology1998，45，22： | 2 |
| 4 | Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford显示文摘BACKGROUND Vedolizumab(VDZ),a humanised monoclonal antibody that selectively inhibits alpha4-beta7 integrins is approved for use in adult moderate to severe ulcerative colitis(UC)patients.AIM To assess the efficacy and safety of VDZ in the real-world management of UC in a large multicenter cohort involving two countries and to identify predictors of achieving remission.METHODS A retrospective review of Australian and Oxford,United Kingdom data for UC patients.Clinical response at 3 mo,endoscopic remission at 6 mo and clinical remission at 3,6 and 12 mo were assessed.Cox regression models and Kaplan Meier curves were performed to assess the time to remission,time to failure and the covariates influencing them.Safety outcomes were recorded.RESULTS Three hundred and three UC patients from 14 centres in Australia and United Kingdom,[60%n=182,anti-TNF naïve]were included.The clinical response was 79%at 3 mo with more Australian patients achieving clinical response compared to Oxford(83%vs 70%P=0.01).Clinical remission for all patients was 56%,62%and 60%at 3,6 and 12 mo respectively.Anti-TNF naive patients were more likely to achieve remission than exposed patients at all the time points(3 mo 66%vs 40%P<0.001,6 mo 73%vs 46%P<0.001,12 mo 66%vs 51%P=0.03).More Australian patients achieved endoscopic remission at 6 mo compared to Oxford(69%vs 43%P=0.01).On multi-variate analysis,anti-TNF naïve patients were 1.8(95%CI:1.3-2.3)times more likely to achieve remission than anti-TNF exposed(P<0.001).32 patients(11%)had colectomy by 12 mo.CONCLUSION VDZ was safe and effective with 60%of UC patients achieving clinical remission at 12 mo and prior anti-TNF exposure influenced this outcome. | Samba Siva Reddy Pulusu Ashish Srinivasan Krupa Krishnaprasad Daniel Cheng Jakob Begun CharlotteKeung Daniel Van Langenberg Lena Thin Tamara Mogilevski Peter De Cruz Graham Radford-Smith Emma Flanagan Sally Bell Soleiman Kashkooli Miles Sparrow Simon Ghaly Peter Bampton Elise Sawyer Susan Connor Quart-ul-ain Rizvi Jane M Andrews Gillian Mahy Paola Chivers Simon Travis Ian Craig Lawrance | 2020 | World Journal of Gastroenterology2020，26，30： | 2 |
| 5 | Risk factors for arterial hypertension in adults with initial optimal blood pressure the strong heart study显示文摘 | de Simone G Devereux RB Chinali M | 2006 | Hypertension2006，47，2： | 1 |
| 6 | Insulin resistance in epileptic girls who gain weight after therapy with valproic acid显示文摘 | Verrotti A Basciani F De Simone M | 2002 | J Child Neurol2002，17，4： | 1 |
| 7 | Superficial siderosis of the CNA:selective central myelin vulnerability and paripheral myelin sparing demonstrated by MRI显示文摘 | Grisoli M Maccagnano T Simone De | 2007 | Eur J Neurol2007，14，： | 1 |
| 8 | Re-evaluating therapeutic neovascularization显示文摘 | de Muinck ED Simons M | | 0，，01： | 1 |
| 9 | Presentation and sur- gicalmanagement of bronchogenic and esophageal duplication cysts inadults显示文摘 | Cioffi U Bonavina LG De Simone M | 1998 | Chest Chicago1998，113，6： | 1 |
| 10 | Photodynamic therapy and the immune system in experimental oncology显示文摘 | Canti G De Simone A Korbelik M | 2002 | Photochem Photobiol Sci2002，1，： | 1 |
| 11 | Cardiac geometry and function in diabetic or prediabetic adolescents and young adults: the Strong Heart Study显示文摘 | De Marco M De Simone G Roman MG | 2011 | Diabetes Care2011，34，10： | 1 |
| 12 | Video-assistedsleeve lobeetomy for mucoepidermoid carcinoma of the left lower lobar bronchus: a case report显示文摘 | Santambrogio L Cioffi U De Simone M | 2002 | Chest2002，121，2： | 1 |
| 13 | Cardiac markers of pre- clinical disease in adolescents with the metabolic syndrome: the strong heart study显示文摘 | Chinali M de Simone G Roman MJ | 2008 | JACC2008，52，11： | 1 |
| 14 | Metabolic syndrome and left ventricular hypertrophy in the prediction of cardiovascular events: the strong heart study显示文摘 | De simone G Devereux RB Chinalin M | 2009 | N utr Metabol Cardiovasc Dis2009，19，： | 1 |
| 15 | Multiple right-sid-ed pulmonary nodules : metastatic cancer or resectable earlystage tumor? 显示文摘 | Cioffi U Raveglia F De Simone M | 2011 | J Cardiothorac Surg2011，6，： | 1 |
| 16 | Metabolic syn- drome and left ventricular hypertrophy in the prediction of car- diovascular events: The Strong Heart Study 显示文摘 | de Simone G Devereux RB Chinali M | 2009 | Nutr Metab Cardiovasc Dis2009，19，2： | 1 |
| 17 | Optimized haemostasis in nephron-sparing surgery using small-intestine submueosa 显示文摘 | Simon J de Petrieoni R Meilinger M | 2008 | BMC Urol2008，29，8： | 1 |
| 18 | Fludarabine and cytarabine as continuous sequential infusion for elderly patients with acute myeloid leukemia显示文摘 | Ferrara F D'Arco AM De Simone M | 2005 | Haematologica2005，90，6： | 1 |
| 19 | Activation of alpha7 nicotinic acetylcholine re- ceptor by nicotine selectively up-regulates cyclooxyge- nase-2 and prostaglandin E2 in rat microglial cultures 显示文摘 | DE SIMONE R AJMONE-CAT M A CARNEVALE D | 2005 | J Neuroinflammation2005，2，： | 1 |
| 20 | Cholesterol depletion inhibits the generation of beta-amyloid in hippocampal neurons 显示文摘 | Simons M Keller P De Strooper B | 1998 | Proc Natl Acad Sci USA1998，95，： | 1 |
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