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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 | Ileal pouch surgery for ulcerative colitis显示文摘Ulcerative colitis (UC) is a relapsing and remitting disease characterised by chronic mucosal and submucosal inflammation of the colon and rectum. Treatment may vary depending upon the extent and severity of inflammation. Broadly speaking medical treatments aim to induce and then maintain remission. Surgery is indicated for inflammatory disease that is refractory to medical treatment or in cases of neoplastic transformation. Approximately 25% of patients with UC ultimately require colectomy. Ileal pouch-anal anastomosis (IPAA) has become the standard of care for patients with ulcerative colitis who ultimately require colectomy. This review will examine indications for IPAA, patient selection, technical aspects of surgery, management of complications and long term outcome following this procedure. | Simon P Bach Neil J Mortensen | 2007 | World Journal of Gastroenterology2007，13，24： | 10 |
| 3 | Studies and characterisations of various activated carbons used for carbon/carbon supercapacitors显示文摘 | J Gamby P.L Taberna P Simon J.F Fauvarque M Chesneau | 2001 | Journal of Power Sources2001，，1： | 3 |
| 4 | Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial显示文摘 | Usha Chakravarthy Simon P Harding Chris A Rogers Susan M Downes Andrew J Lotery Lucy A Culliford Barnaby C Reeves | 2013 | The Lancet2013，，： | 2 |
| 5 | Nutrient budgets in intensive shrimp ponds:implications for sustainability显示文摘 | MATTHEW R P | 1998 | Aquaculture1998，，： | 1 |
| 6 | Electrode compositions for carbon power supercapacitors显示文摘 | BONNEFOI L SIMON P FAUVARQUE J F | 1999 | J Power Sources1999，80，： | 1 |
| 7 | Residual-effeeted homogeneous charge compression ignition at a low compression ratio using exhaust reinduetion显示文摘 | Citon P A Simon A J Jerdes J C | 2003 | Int J Engine Res2003，4，3： | 1 |
| 8 | Comparing imagery and verbal instructions for the experimental modification of interpretation and judgmental bias in children显示文摘 | Stephanos P Vassilopoulos Simon E Blackwell Nicholas J Moberly Eleni Karahaliou | | 0，，01： | 1 |
| 9 | 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 |
| 10 | Effects of nanosecond pulsed electric field exposure on arabidopsis thaliana 显示文摘 | Christian J E Simone B Michael P | 2009 | IEEE Transactions on Dielectrics and Electrical Insulation2009，16，5： | 1 |
| 11 | Pre - B - cell colo- ny - enhancing factor as a potential novel biomarker in acute lung in- jury显示文摘 | YE S Q SIMON B A MALONEY J P | 2005 | Am J Respir Crit Care Med2005，171，4： | 1 |
| 12 | Ultra-Fast Cooling on the Run-Out Table of the Hot Strip Mill显示文摘 | Simon P Fischbach J P Riche Ph | 1996 | La Revue de Métallurgie-CIT1996，，3： | 1 |
| 13 | Biochemistry of the chromogranin A protein family显示文摘 | SIMON J P AUNIS D | 1989 | Biochemistry Journal1989，262，： | 1 |
| 14 | Outcomed and clinicopa thologic variables associated with late recurrence after nephrectomy fkr localiged Renal cell carcinoma显示文摘 | SIMON P K CHRISTOPHER J M BRADLEY C L | 2011 | Urology2011，78，5： | 1 |
| 15 | Studies and characterisations of various activated carbons used for carbon/carbon supercapacitors 显示文摘 | Gamby J Taberna P L Simon P | 2001 | J Power Sources2001，101，1： | 1 |
| 16 | Electrochemical characteristics and impedance spectroscopy studies of carbon-carbon supercapacitors显示文摘 | TABERNA P L SIMON P FAUVARQUE J F | 2003 | J Electrochem Soc2003，150，3： | 1 |
| 17 | Alteration of the quality of milk by expression of sheep beta-lactoglobulin in transgenic mice显示文摘 | Simons J P McClenaghan M Clark A J | 1987 | Nature1987，328，： | 1 |
| 18 | Pre-B-cell colony-enhancing factor as a potential novelbiomarker in acute lung injury 显示文摘 | YE S Q SIMON B A MALONEY J P | 2005 | Am J RespirCrit Care Med2005，171，4： | 1 |
| 19 | A national propensity-adjusted analysis of adjuvant radiotherapy in the treatment of resected pancreatic adenocarcinoma显示文摘 | Mcdade T P Hill J S Simons J P | 2010 | Cancer2010，116，13： | 1 |
| 20 | A Benthic community index for streams in the northern lakes and forests ecoregion 显示文摘 | Butcher J T Stewar P M Simon T P | 2003 | Ecological Indicators2003，3，3： | 1 |
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