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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 | 血浆游离DNA水平增高可作为预测重型颅脑损伤患者死亡率的独立指标(英文)显示文摘Trauma is the leading cause of death under 45 years worldwide and up to 50% of trauma fatalities are due to brain injury.Prediction of outcome is one of the major problems associated with severe TBI and research efforts have focused on the investigation of biomarkers with prognostic value following TBI. Therefore,our aim was to investigate whether cell-free DNA concentrations correlated to short-term primary outcome( survivor or death) and GCS scores following severe TBI. A total of 188 victims of severe TBI were enrolled in this prospective study,outcome variables comprised: survival and neurological assessment using the GCS at ICU discharge. Control blood samples were obtained from 25 healthy volunteers. Peripheral venous blood was collected at admission in the ICU. Plasma DNA was measured using a real-time quantitative PCR assay for the β-globin gene. There was correlation between higher DNA levels and both fatal outcome and lower hospital admission GCS scores. Plasma DNA concentrations at the chosen cut- off point( ≥171,381 kilogenomesequivalents /L) predicted mortality with a specificity of 90% and a sensitivity of 43%. Logistic regression analysis showed that elevated plasma DNA levels were independently associated with death( P < 0. 001). In conclusion,high cell-free DNA concentration was a predictor of short-term mortality following severe TBI. | Rodrigues Filho EM1 Simon D Ikuta N Klovan C Dannebrock F de Oliveira CO Regner A | 2014 | 中华神经外科疾病研究杂志2014，13，3： | 6 |
| 3 | 查看详情显示文摘 | Mijatovic T De Nève N Bruyère C Simon G Dewelle J Van Quaquebeke E Van Der A.E Van Vynckt F Lefranc F Kiss R | | 0，，： | 1 |
| 4 | A novel and easy method for the production of recombinant peptides for use in the generation of monospecific antisera against Lama glama IgG2b and IgG2c subclasses显示文摘 | Saccodossi N De Simone E Leoni J | 2006 | J Immunol Methods2006，313，12： | 1 |
| 5 | Antiphospholipid antibodies affect trophoblast gonadotropin secretion and invasiveness by binding directly and through adhere beta2 - glycoprotion I 显示文摘 | Di Simone N Meroni PL De Papa N | 2000 | Arthritis Rheum2000，43，： | 1 |
| 6 | Granular cell tumor of the breast : Clinical and pathologic characteristics of a rare case in a 14-year-old girl显示文摘 | De Simone N Aggon A Christy C | 2011 | J Clin Oncol2011，29，22： | 1 |
| 7 | Hypoglycemic effects of sesquiterpene glycosides and polyhydroxylated triterpenoids of Eriobotrya japonica显示文摘 | de Tommasi N de Simone F Cirino G | 1991 | Planta Med1991，57，5： | 1 |
| 8 | Constituents of Eriobotrya japonica,a study of their antiviral properties显示文摘 | de Tommasi N de Simone F Pizza C | 1992 | J Nat Prod1992，55，8： | 1 |
| 9 | Constitu- ents of Eriobotrya japonica : A study of their antiviral properties显示文摘 | De TOMMASI N De SIMONE F PIZZA C | 1992 | Journal of Natural Products1992，55，8： | 1 |
| 10 | Hypoglycemic Effects of Sesquiterpene Glycosides and Polyhydroxylated Triterpenoids of Efio- botrya japonica显示文摘 | De Tommasi N De Simone F Cirino G | 1991 | Planta medica1991，57，05： | 1 |
| 11 | Plant metabolites,new sesquiterpene glycosides from Eriobotrya japonica显示文摘 | de Tommasi N de Simone F Aquino F | 1990 | J Nat Prod1990，53，4： | 1 |
| 12 | Plant meta-bolites,new sesquiterpene and ionone glycosides from Eriobotrya japonica显示文摘 | de Tommasi N Aquino R de Simone F | 1992 | J Nat Prod1992，55，8： | 1 |
| 13 | Triterpenes and quinovic acid glycosides from Uncaria tomentosa 显示文摘 | AQUINO R de TOMMASE N de SIMONE F | 1997 | Phytochemistry1997，45，5： | 1 |
| 14 | Hypoglycemic effects of sesquiterpene glycosides and polyhydroxtlated triterpenes of Eriobotrya japonic显示文摘 | de Tommasi N de Simone F Cirino G | 1991 | Planta Med1991，57，： | 1 |
| 15 | A previously undescribed coronavirus associated with respiratory disease in humans显示文摘 | Fouchier R A M Hartwig N G Bestebroer T M Niemeyer B de Jong J C Simon J H Osterhaus A D | 2004 | PNAS2004，101，： | 1 |
| 16 | Antiphospholipid antibod- ies affect trophoblast gonadotropin secretion and invasiveness by bind- ing directly and through adhered beta2-glycoprotein-I 显示文摘 | Di Simone rq Meroni PL de Papa N | 2000 | Arthritis Rheum2000，43，1： | 1 |
| 17 | Hypoglycemic effect of sesquiterpene glycosides and polyhydroxylated trierpenoids of Eriobotrya japonica显示文摘 | De Tommasi N De simone F Cirino G | 1991 | Planta Med1991，57，5： | 1 |
| 18 | Structural analysis of effector functions related motifs, complement activation and hemagglutinating activities in Lama glama heavy chain antibod- ies显示文摘 | Saccodossi N De Simone E A Leoni J | 2012 | Vet Immunol Immunopathol2012，145，12： | 1 |
| 19 | Antiphospholipid antibodies affect trophoblast gonadotropin secretion and invasiveness by binding directly and through adhered beta2-glyeoprotein Ⅰ显示文摘 | Di Simone N Meroni PL de Papa N | 2000 | Arthritis Rheum2000，43，1： | 1 |
| 20 | Hypoglycemic effects of sesquiterpene glycosides and polyhydroxtlate tirterpenes of Eriobotrya japonic 显示文摘 | DE TOMMASI N DE SIMONE F CIRINO G | 1991 | Planta Medica1991，57，： | 1 |
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