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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 | Refining pathological evaluation of neoadjuvant therapy for adenocarcinoma of the esophagus显示文摘AIM:To assess tumour regression grade(TRG)and lymph node downstaging to help define patients who benefit from neoadjuvant chemotherapy.METHODS:Two hundred and eighteen consecutive patients with adenocarcinoma of the esophagus or gastro-esophageal junction treated with surgery alone or neoadjuvant chemotherapy and surgery between 2005and 2011 at a single institution were reviewed.Triplet neoadjuvant chemotherapy consisting of platinum,fluoropyrimidine and anthracycline was considered for operable patients(World Health Organization performance status≤2)with clinical stage T2-4 N0-1.Response to neoadjuvant chemotherapy(NAC)was assessed using TRG,as described by Mandard et al.In addition lymph node downstaging was also assessed.Lymph node downstaging was defined by cN1 at diagnosis:assessed radiologically(computed tomography,positron emission tomography,endoscopic ultrasonography),then pathologically recorded as N0 after surgery;ypN0 if NAC given prior to surgery,or pN0if surgery alone.Patients were followed up for 5 years post surgery.Recurrence was defined radiologically,with or without pathological confirmation.An association was examined between t TRG and lymph node downstaging with disease free survival(DFS)and a comprehensive range of clinicopathological characteristics.RESULTS:Two hundred and eighteen patients underwent esophageal resection during the study interval with a mean follow up of 3 years(median follow up:2.552,95%CI:2.022-3.081).There was a 1.8%(n=4)inpatient mortality rate.One hundred and thirty-six(62.4%)patients received NAC,with 74.3%(n=101)of patients demonstrating some signs of pathological tumour regression(TRG 1-4)and 5.9%(n=8)having a complete pathological response.Forty four point one percent(n=60)had downstaging of their nodal disease(cN1 to ypN0),compared to only 15.9%(n=13)that underwent surgery alone(pre-operatively overstaged:cN1 to pN0),(P<0.0001).Response to NAC was associated with significantly increased DFS(mean DFS;TRG 1-2:5.1years,95%CI:4.6-5.6 vs TRG 3-5:2.8 years,95%CI:2.2-3.3,P<0.0001).Nodal down-staging conferred a significant DFS advantage for those patients with a poor primary tumour response to NAC(median DFS;TRG 3-5 and nodal down-staging:5.533 years,95%CI:3.558-7.531 vs TRG 3-5 and no nodal down-staging:1.114 years,95%CI:0.961-1.267,P<0.0001).CONCLUSION:Response to NAC in the primary tumour and in the lymph nodes are both independently associated with improved DFS. | Fergus Noble Luke Nolan Adrian C Bateman James P Byrne Jamie J Kelly Ian S Bailey Donna M Sharland Charlotte N Rees Timothy J Iveson Tim J Underwood Andrew R Bateman | 2013 | World Journal of Gastroenterology2013，19，48： | 4 |
| 3 | Relationship of superficial scald development and ct-Farnesene oxidation to re- actions of diphenylamine and diphenylamine derivatives in CV, Granny Smith apple peel 显示文摘 | David R R James P M John K F | 2005 | J Agric Food Chem2005，，53： | 1 |
| 4 | Indole-3-aldehyde显示文摘 | James P N Snyder H R | 1963 | Org Synth Coll1963，，4： | 1 |
| 5 | Aluminm alloy 2519 in military vehicles显示文摘 | James J F Lawrence S K Joseph R P | 2002 | Advanced Materials and Processes2002，160，9： | 1 |
| 6 | Aluminum alloy 2519 in military vehicles显示文摘 | James J F Lawrence S K Joseph R P | 2002 | Advanced Materials and Processes2002，160，9： | 1 |
| 7 | Mechanisms of thermoregulation and water balance in desert un- gulates 显示文摘 | JAMES III W KRAUSMAN P R ROSENSTOCK S S | 2006 | Wildlife Society Bulletin2006，34，3： | 1 |
| 8 | Photorefractive volume holographic demodulation of in-fiber Bragg grating sensors 显示文摘 | S W James M L Dockney R P Tatam | 1996 | IEEE Photon Technol Lett1996，8，5： | 1 |
| 9 | Troponin T levels and risks of 30-day outcomes in patients with the acute coronary syndrome:prospective verification in the GUSTO-Ⅳ trial显示文摘 | James S Armstrong P Califf R | | 0，，03： | 1 |
| 10 | Psychological climate:Dimensions and rela- tionships of individual and aggregated work environment perceptions 显示文摘 | JONES A P JAMES L R | 1979 | Organizational behavior and human performance1979，23，2： | 1 |
| 11 | Catalysis at the metal-support interface exemplified by the photocatalytic reforming of methanol on Pd/TiO2显示文摘 | BOWKER M JAMES D STONE P BENNETT R PERKINS N MILLARD L GREAVES J DICKINSON A | 2003 | J Catal2003，217，2： | 1 |
| 12 | Genome, transcriptome, and secretome analysis of wood decay fungus Postia placenta supports unique mechanisms of lignocellulose conversion 显示文摘 | Martinez D Challacombe J Morgenstern 1 Hibbett D Schmoll M Kubicek CP Ferreira P Ruiz-Duenas FJ Martinez AT Kersten P Hammel KE Wymelenberg AV Gaskell J Lindquist E Sabat G BonDurant SS Larrondo LF Canessa P Vicuna R Yadav J Doddapaneni H Subramanian V Pisabarro AG Lavin JL Oguiza JA Master E Henrissat B Coutinho PM Harris P Magnuson JK Baker SE Bruno K Kenealy W Hoegger PJ Kties U Ramaiya P kucas S Salamov A Shapiro H Tu H Chee CL Misra M Xie G Teter S Yaver D James T Mokrejs M Pospisek M Grigoriev IV Brettin T Rokhsar D Berka R Cullen D | 2009 | PNAS2009，106，6： | 1 |
| 13 | Titanium alloys on the F-22 fighter airframe显示文摘 | James D C Larry P C Herry R P | 2002 | Advanced Materials and Processes2002，160，5： | 1 |
| 14 | Neutronreflectivity studies at liquid-liquid interfaces:Methodology and analysis显示文摘 | Ali Zarbakhsh Webster R P | 2001 | Langmuir2001，，17： | 1 |
| 15 | Measurement of pulsatile hormone release from perifused pituitary cells immobilized on microcarriers显示文摘 | Michael Conn P | 1990 | Methlds in Neurosciences1990，，2： | 1 |
| 16 | Indole-3-carboxaldehyde显示文摘 | James P N Snyder H R | 1961 | Org Synth1961，39，： | 1 |
| 17 | Tourism and the changing photographic image of the great lakes indians显示文摘 | Albers P C James W R | 1983 | Annals of Tourism Research1983，10，1： | 1 |
| 18 | An Empirical Study of Impact of Crossover Operators on the Performance of Non-binary Genetic Algorithm based Neural Approaches for Classi cation 显示文摘 | Parag C P James A R | 2004 | Computers Operations Research2004，31，6： | 1 |
| 19 | Crystallization of para-Xylene in Scraped-Surface Crystallizers显示文摘 | Daniel B P James B R Hazim A M | 2001 | AICh E J2001，47，11： | 1 |
| 20 | Experimental Investigation of CO2- brine-rock interactions at elevated temperature and pressure: Implica- tions for CO2 sequestration in deep saline aquifers显示文摘 | Robert J R Tamer K James L P | 2005 | Fuel Processing Technology2005，86，： | 1 |
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