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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 | Association of types of diabetes and insulin dependency on birth outcomes显示文摘BACKGROUND Diabetes rates among pregnant women in the United States have been increasing and are associated with adverse pregnancy outcomes.AIM To investigate differences in birth outcomes(preterm birth,macrosomia,and neonatal death)by diabetes status.METHODS Cross-sectional design,using linked Missouri birth and death certificates(singleton births only),2010 to 2012(n=204057).Exposure was diabetes non-diabetic,pre-pregnancy diabetes-insulin dependent(PD-I),pre-pregnancy diabetes-non-insulin dependent(PD-NI),gestational diabetes-insulin dependent(GD-I),and gestational diabetes-non-insulin dependent(GD-NI).Outcomes included preterm birth,macrosomia,and infant mortality.Confounders included demographic characteristics,adequacy of prenatal care,body mass index,smoking,hypertension,and previous preterm birth.Bivariate and multivariate logistic regression assessed differences in outcomes by diabetes status.RESULTS Women with PD-I,PD-NI,and GD-I remained at a significantly increased odds for preterm birth(aOR 2.87,aOR 1.77,and aOR 1.73,respectively)and having a very large baby[macrosomia](aOR 3.01,aOR 2.12,and aOR 1.96,respectively);in reference to non-diabetic women.Women with GDNI were at a significantly increased risk for macrosomia(aOR1.53),decreased risk for their baby to die before their first birthday(aOR 0.41)and no difference in risk for preterm birth in reference to non-diabetic women.CONCLUSION Diabetes is associated with the poor birth outcomes.Clinical management of diabetes during pregnancy and healthy lifestyle behaviors before pregnancy can reduce the risk for diabetes and poor birth outcomes. | Pamela K Xaverius Steven W Howard Deborah Kiel Jerry E Thurman Ethan Wankum Catherine Carter Clairy Fang Romi Carriere | 2022 | World Journal of Clinical Cases2022，10，7： | 2 |
| 3 | Fast accurate fuzzy clustering through data reduction 显示文摘 | Steven E Jing W K Lawrence O | 2003 | IEEE Trans on Fuzzy Systems2003，11，2： | 1 |
| 4 | An Object-Oriented Modeling Environment显示文摘 | Steven Berson E William Dheng C | 1989 | PSL''89 Proceedings1989，11，： | 1 |
| 5 | 显示文摘 | Patrik P Anders E W Steven S | 2002 | J Mater Process Technol2002，127，1： | 1 |
| 6 | A single-molecule study of RNA catalysis and folding 显示文摘 | Zhuang X W Bartley L E Steven Chu | 2000 | Science2000，288，： | 1 |
| 7 | Self-propagating high-temperature synthesis and liquid-phase sintering of TiC/Fe composites 显示文摘 | Patril Persson Anders E W Jarfors Steven Savage | 2002 | Journal of Materials Processing Technology2002，127，： | 1 |
| 8 | Generating surfaces of daily meteorological variables over large regions of complex terrain 显示文摘 | Peter E Thornton Steven W Running Michael A White | 1997 | Journal of Hydrology1997，190，： | 1 |
| 9 | Distribution of sturgeon larvae in the Sacramento-San Joaquin River system显示文摘 | Stevens D E Miller L W | 1970 | California Fish and Game1970，56，2： | 1 |
| 10 | Optimal control of a liberating eleetrodynamie tether performing a muhirevolution orbitehange 显示文摘 | Stevens R E Baker W P | 2009 | Journal of Guidance Control and Dynamics2009，32，5： | 1 |
| 11 | 显示文摘 | STEVEN E W DANIEL H E HOUK K N | 2008 | J Phys Chem A2008，112，： | 1 |
| 12 | An MDP-based vertical handoff decision algorithm for heterogeneous wireless net- works 显示文摘 | Stevens Navarro E Lin Y X Vincent Wong W S | 2008 | IEEE Transactions on Vehicular Technology2008，57，2： | 1 |
| 13 | Self-propagating high-temperature synthesis and liquid-phase sintering of TiC/Fe composites 显示文摘 | Patril Persson Anders E W Jarfors Steven Savage | 2002 | Materials Processing Technology2002，127，： | 1 |
| 14 | Identification of an HIV-1 Mutation in Spacer Peptide 1That Stabilizes the Immature CASP1Lattice显示文摘 | Fontana J Keller P W Urano E Ablan S D Steven A C Freed E O | 2016 | J Virol2016，90，2： | 1 |
| 15 | Eleven eases of thallium intoxication treated with Prussian Blue 显示文摘 | Stevens W e! al | 1974 | Int J Clin Pharmacol Therap Toxicol1974，10，： | 1 |
| 16 | An improved algorither for estimating incident daily solar radiation from measurements of tempersture, humidity, and precipitation 显示文摘 | Thornton P E Steven W | 1999 | Agricultural and Forest Meteorology1999，93，4： | 1 |
| 17 | Shell-side mass-transfer performance in hollow- fiber membrane contactors 显示文摘 | SHEN S F KENTISH S E STEVENS G W | 2010 | Solvent Extraction and Ion Exchange2010，28，6： | 1 |
| 18 | Analysis of pursuit tracking eye movements in pilots and nonfliers 显示文摘 | ENGELKEN E J STEVENS K W BELL A F | 1994 | Biomedical Sciences Instrumentation1994，30，： | 1 |
| 19 | The effect of condensable minor components on the gas separation performance of polymeric membranes for carbon dioxide capture显示文摘 | Scholes C A Kentish S E Stevens G W | 2009 | Energy Procedia2009，1，： | 1 |
| 20 | Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial显示文摘 | Talmadge E King Carlo Albera Williamson Z Bradford Ulrich Costabel Phil Hormel Lisa Lancaster Paul W Noble Steven A Sahn Javier Szwarcberg Michiel Thomeer Dominique Valeyre Roland M du Bois | 2009 | The Lancet . 2009 (9685)2009，，： | 1 |
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