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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 | Risk-adjustment in hepatobiliarypancreatic surgery显示文摘AIM: The present study evaluates the performance of the POSSUM, the American Society of Anesthetists (ASA),APACHE and Childs classification in predicting mortality and morbidity in hepatopancreaticobiliary (HPB) surgery.We describe especially the limitations and advantages of risk in stratifying the patients.METHODS: We investigated 177 randomly chosen patients undergoing eledive complex HPB surgery in a single institution with a total of 71 pre-operative and intra-operative risk factors.Primary endpoint was in-hospital mortality and morbidity.Ordered logistic regression analysis was used to identify individual predictors of operative morbidity and mortality.RESULTS: The operative mortality in the series was 3.95% .This compared well with the p-POSSUM and APACHE predicted mortality of 4.31% and 4.29% respectively. Postoperative complications amounted to 45% with 24 (13.6%)patients having a major adverse event. On multivariate analysis the pre-operative POSSUM physiological score (OR = 1.18,P = 0.009) was superior in predicting complications compared to the ASA (P = 0.108), APACHE (P = 0.117)or Childs classification (P = 0.136). In addition, serum sodium, creatinine, international normalized ratio (INR),pulse rate, and intra-operative blood loss were independent risk factors. A combination of the POSSUM variables and INR offered the optimal combination of risk factors for risk prognostication in HPB surgery.CONCLUSION: Morbidity for elective HPB surgery can be accurately predicted and applied in everyday surgical practice as an adjunct in the process of informed consent and for effective allocation of resources for intensive and high-dependency care facilities. | Hemant M Kocher Paris P Tekkis Palepu Gopal Ameet G Patel Simon Cottam Irving S Benjamin | 2005 | World Journal of Gastroenterology2005，11，16： | 3 |
| 3 | Themomechanical properties and morphology of blends of a hydroxyl-functionalized hyperbranched polymer and epoxy resin显示文摘 | RATNA D SIMON G P | 2001 | Polymer2001，42，21： | 1 |
| 4 | TNFalpha and its receptors in psoriatic skin,before and after treatment with etanercept显示文摘 | Caldarola G De Simone C Carbone A Tulli A Amerio P Feliciani C | 2009 | Int J Immunopathol Pharmacol2009，22，4： | 1 |
| 5 | Carrying capacity in the tourism industry: a case study of Hengistbury Head显示文摘 | Simon F J G Narangajavana Y Marquis D P | 2004 | Tourism Manage- ment2004，25，： | 1 |
| 6 | Impacts of land use conflicts on riverine ecosystems 显示文摘 | Renato F Valle Junior Simone G P Varandas Femando A L Pacheco | 2014 | Land Use Policy2014，43，： | 1 |
| 7 | Symmetry-based re- sistance as a novel means of lower limb rehabilitation 显示文摘 | Simon A M Brent G R Ferris D P | 2007 | Journal of Biomechanics2007，40，6： | 1 |
| 8 | Characterization of as- phaltenes and resins from problematic Mexican crude oils 显示文摘 | Eduardo B G Marcela E P Simon I A | 2001 | Petro- leum Sci Technol2001，19，34： | 1 |
| 9 | Early failure of the tissue engineered porcine heart valve SYNERGRAFT in pediatric patients显示文摘 | Kasimir MT Seebacher G | 2003 | Eur J Cardiothorac Surg2003，23，6： | 1 |
| 10 | Water absorption and states of water in smicrystalline poly (vinyl alcohol ) films 显示文摘 | Hodge R M Edward G H Simon G P | 1996 | Polymer1996，37，： | 1 |
| 11 | Early failure of the tissue engineered porcine heart valve in pediatric patients 显示文摘 | Simon P Kasimir MT Seebacher G | 2003 | Eur J Car- diothorac Surg2003，23，6： | 1 |
| 12 | De- velopment of polymer-ceramic composites for improved fire resistance显示文摘 | HANU L G SIMON G P MANSOURI J | 2004 | J Mater Process Technol2004，153，： | 1 |
| 13 | Copper-Zinc-Cobalt-Aluminium-Chromium Hydroxycarbonates and Mixed Oxides显示文摘 | Simone G Mariano L J Piero P | 1996 | J SolidState Chem1996，122，： | 1 |
| 14 | The SAPIO syndrome--are microbes in- volved?显示文摘 | Assmann G Simon P | 2011 | Best Pract Res Clin Rheumatol2011，25，3： | 1 |
| 15 | Early failure of the tissue engineered porcine heart valve SYNERGRAFT in pediatric patients 显示文摘 | Simon P Kasimir MT Seebacher G | 2003 | Eur J Cardiothorac Surg2003，23，6： | 1 |
| 16 | Nanocomposites of poly (methyl methacry- late) and organically modified layered silicates by melt intercalation显示文摘 | Shen Z Simon G P Cheng Y B | 2004 | J ADpl Polym Sci2004，92，： | 1 |
| 17 | AFLP-based fine mapping of the Mlo gene to a 30-kb DNA segment of the barley genome显示文摘 | VANDER L T DIERGAARDE P | 1997 | Genetics1997，44，： | 1 |
| 18 | Comparison of solution intercalation and melt intercalation of polymer-clay nanocomposites 显示文摘 | SHEN Z Q SIMON G P CHENG Y B | 2002 | Polyer2002，43，： | 1 |
| 19 | Metallophthalocyanines gas sensors, resistors and field effect transistors显示文摘 | GUILLAUD G SIMON J GERMAIN J P | 1998 | Coordination Chemistry Reviews1998，，： | 1 |
| 20 | Effect of paraox- onase I polymorphism oll clinical outcomes in patients treated with clopidogrel after an acute myocardial infarction 显示文摘 | Simon T Steg P G Becquemont L | 2011 | Clinical Pharmacology & Therapeutics2011，90，4： | 1 |
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