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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 | Diagnostic accuracy of tests for Helicobacter pylori in an Alaska Native population显示文摘AIM:To evaluate the accuracy of two non-invasivetests in a population of Alaska Native persons. Highrates of Helico bacter pylori(H. pylori) infection,H. pylori treatment failure,and gastric cancer in this population necessitate documentation of infection status atmultiple time points over a patient's life.METHODS:In 280 patients undergoing endoscopy,H. pylori was diagnosed by culture,histology,rapidurease test,13C urea breath test(UBT) ,and immuno-globulin G antibodies to H. pylori in serum. The performances of 13C-UBT and antibody test were compared to a gold standard defined by a positive H. pylori testby culture or,in case of a negative culture result,bypositive histology and a positive rapid urease test.RESULTS:The sensitivity and specificity of the 13C-UBT were 93% and 88%,respectively,relative to thegold standard. The antibody test had an equivalents ensitivity of 93% with a reduced specificity of 68%.The false positive results for the antibody test were as-sociated with previous treatment for an H. pylori infection [relative risk(RR) = 2.8]. High levels of antibodiesto H. pylori were associated with chronic gastritis and male gender,while high scores in the 13C-UBT testwere associated with older age and with the H. pyloribacteria load on histological examination(RR = 4.4) .CONCLUSION:The 13C-UBT out performed the anti-body test for H. pylori and could be used when a non-invasive test is clinically necessary to document treatment out come or when monitoring for reinfection. | Dana L Bruden Michael G Bruce Karen M Miernyk Julie Morris Debby Hurlburt Thomas W Hennessy Helen Peters Frank Sacco Alan J Parkinson Brian J McMahon | 2011 | World Journal of Gastroenterology2011，17，42： | 3 |
| 3 | On Cloaking for Elasticity and Physical Equations with A Transformation Invariant Form 显示文摘 | Milton G W Briane M Willis J R | 2006 | New J Phys2006，8，： | 1 |
| 4 | Recombination and coronavirus defective interfering RNAs显示文摘 | Brian D A Spaan W J M | 1997 | Semin Virol1997，8，： | 1 |
| 5 | Anisotropy correction for devlated-well sonic logs: application to seismic well tie显示文摘 | Brian E H John M H Donald W I | 2003 | Geophysics2003，68，2： | 1 |
| 6 | The influence of water level fluctuations on the growth of four emergent macrophyte species 显示文摘 | Brian M D Sean D W George G G | 2007 | Aquatic Botany2007，86，4： | 1 |
| 7 | Sohd-phase sediment toxicity identification evaluation in an agricultural stream显示文摘 | Bryn M Philips Brian S Anderson John W Hunt | 2006 | Environmental Toxicology and Chemistry2006，25，6： | 1 |
| 8 | Microbial populations responsible for specific soil suppressiveness to plant pathogens显示文摘 | David M W Jos M R Brian B M | 2002 | Phytopathol2002，，40： | 1 |
| 9 | The critical periedsfor weed control in white beans显示文摘 | Brian I W Thomas E M Michael R H | 1999 | Weed Science1999，41，： | 1 |
| 10 | Interactive seismic facies classi- fication using textural attributes and neural networks 显示文摘 | Brian P W Steve R M John E E | 2002 | The Leading Edge2002，21，10： | 1 |
| 11 | A physiological comparison of gibberellic acid with some auxins 显示文摘 | BRIAN P W RADLEY M | 1955 | Physiologia Plantarum1955，，8： | 1 |
| 12 | The Critical periods for weed control in white beans显示文摘 | BRIAN I W THOMAS E M MICHAEL R H | 1999 | Weed Science1999，41，： | 1 |
| 13 | Population changes in Phytophthora infestans in Taiwan associated with the appearance of resistance to metalaxyl 显示文摘 | BRIAN C M MICHELE Q RICHARD W J | 2002 | Pest Management Science2002，58，9： | 1 |
| 14 | Aggressive contests in house crickets:size,motivation and the infor- mation content of aggressive songs 显示文摘 | BROWN W D SMITH A T BRIAN M | 2006 | Animal Behaviour2006，72，1： | 1 |
| 15 | Effects of silicon carbide deposition from methyltrichlorosilane显示文摘 | Theodore M B Brian W S Thomas S M | 1992 | J Am Ceram Soc1992，75，10： | 1 |
| 16 | Landsat-based Inventory of Gla- ciers in Western Canada, 1985-2005显示文摘 | Tobias B Brian M Roger W | 2010 | Remote Sensing of Environment2010，114，： | 1 |
| 17 | Transoral Incisionless Fundoplication: 2-year Results from the Prospective Multicenter U.S. Study显示文摘 | Bell Reginald C W Barnes William E Carter Bart J Sewell Robert W Mavrelis Peter G Ihde Glenn M Hoddinott Kevin M Fox Mark A Freeman Katherine D Gunsberger Tanja Hausmann Mark G Dargis David Gill Brian DaCosta Wilson Erik Trad Karim S | 2014 | The American Surgeon2014，，11： | 1 |
| 18 | Shape-controlled synthesis of metal nanostructures: The ease of silver 显示文摘 | Benjamin W Yugang S Brian M | 2005 | Chem Eur J2005，11，： | 1 |
| 19 | Optical Properties of Tm^3+ Ions in Alkali Germanate Glass显示文摘 | Brian M W Norman P B Donald J R | 2006 | Journal of Non-Crystalline Solids2006，352，： | 1 |
| 20 | Dysnatremias and Survival in Adult Burn Patients: A Retrospective Analysis显示文摘 | Stewart Ian J Morrow Benjamin D Tilley Molly A Snow Brian D Gisler Christopher Kramer Keith W Aden James K Renz Evan M Chung Kevin K | 2013 | American Journal of Nephrology2013，，1： | 1 |
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