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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 | An implementation assessment of China's Environmental Information Disclosure Decree显示文摘China's 2007 Open Government Information Regulations is widely considered as a milestone in the country's information policy history and is praised as a'sunshine program'.The Environmental Information Disclosure Decree was the first to operationalize these general regulations into a sectoral information disclosure system on environment.This study assessed the implementation of the environmental information disclosure system about six months after the Decree took eect on May 1,2008.Through reviewing the websites of all 31 provincial Environmental Protection Bureaus and the Ministry of Environmental Protection,conducting an experiment with actual information disclosure request,and through interviews with all provincial Environmental Protection Bureaus,this article concluded that the implementation of the environmental information disclosure system still falls short.Future improvements should focus on further publicity of the regulations and decree to enhance public participation,the establishment of an independent evaluation and supervision system for information disclosure,the exchange of experiences and best practices among provincial Environmental Protection Bureaus,and on strengthening the legal status of environmental information disclosure. | Lei Zhang Arthur E J Mol Guizhen He Yonglong Lu | 2010 | Journal of Environmental Sciences2010，22，10： | 9 |
| 3 | Multisecret-sharing scheme based on one-way function显示文摘 | He J Dawson E | 1995 | Electronics Letters1995，31，2： | 1 |
| 4 | Energetics of charged point defects in rutile TiO2 by density functional theory显示文摘 | LI X FINNIS M W HE J BEHERA R K PHILLPOT S R SINNOTT S B DICKEY E C | 2009 | Acta Materialia2009，57，： | 1 |
| 5 | Mechanical alloying of immiscible elements:Al-Fe contrasted with Cu-Fe显示文摘 | Ma E He J H Schilling P J | 1997 | Physical Review B1997，55，9： | 1 |
| 6 | Multisecret-sharing Scheme Based on One-way Function 显示文摘 | He J Dawson E | 1995 | Electronics Letters1995，31，2： | 1 |
| 7 | Transient performance of linear induction launchers fed by generators and by capacitor banks 显示文摘 | He J L Zabar Z Levi E | 1991 | IEEE Transactions on Magnetics1991，27，1： | 1 |
| 8 | Multistage secret sharing based on one-way function 显示文摘 | HE J DAWSON E | 1994 | Electronic Letters1994，30，19： | 1 |
| 9 | Polymorphisms in the IL13, IL13RA1 and IL4RA genes and rates of decline of lung function in smokers 显示文摘 | He J Q Connett J E Anthonisen N R | 2003 | Am J Respir Cell Mol Biol2003，28，3： | 1 |
| 10 | Solid-state alloying in nano- structured binary systems with positive heat of mixing显示文摘 | MA E SHENG H W He J H | 2000 | Mate- rials Science and Engineering: A2000，286，： | 1 |
| 11 | Multisecret sharing scheme based on one way function显示文摘 | He J Dawson E | 1995 | Electronics Letters1995，31，2： | 1 |
| 12 | Dysfunction in mitochondria in human skeletal muscle in type 2 diabetes显示文摘 | KELLEY D E HE J MENSHIKOVA E V | 2002 | Diabetes2002，51，： | 1 |
| 13 | Catalysis of the isocya- nate- hydroxyl reaction by non -tin catalysts 显示文摘 | Blank W J He Z A Hessell E T | 1999 | Progress in Organic Coatings1999，35，： | 1 |
| 14 | Mechanical alloying of immisci- ble elements:Ag-Fe contrasted with Cu-Fe显示文摘 | MA E HE J H Schilling P J | 1997 | Physical Review: B1997，55，9： | 1 |
| 15 | Long term follow-up of conservatively treated popliteal cysts in children 显示文摘 | Van Rhijn LW Jansen E J Pruijs HE | 2000 | J Pediatr orthop B2000，9，： | 1 |
| 16 | Emdogain promotes osteoblast proliferation and differentiation and stimulates osteoprotegerin expression 显示文摘 | He J Jiang J Safari K E | 2004 | Oral Surg Oral Med Oral Pathol Oral Radial Endod2004，97，2： | 1 |
| 17 | The adsorption of microcystin-LR by natural clay particles 显示文摘 | Morris R J Williams D E Luu He A | 2000 | Toxicon2000，38，2： | 1 |
| 18 | Analysis of induction-type coilgun performance based on cylindrical current sheet model显示文摘 | He J L Zabar Z Levi E | 1991 | IEEE Trans on Magnetics1991，27，1： | 1 |
| 19 | Fractionation of lead in paddy soils and its bioavailability to rice plants显示文摘 | Li J X Yang X E He Z L | 2007 | Geoderma2007，141，34： | 1 |
| 20 | Design tool and guidelines for outdoor photobioreactors显示文摘 | Lee E Pruvost J He X | 2014 | Chemical Engineering Science2014，106，： | 1 |
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