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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 | High-intensity focused ultrasound ablation:An effective bridging therapy for hepatocellular carcinoma patients显示文摘AIM:To analyze whether high-intensity focused ultrasound(HIFU) ablation is an effective bridging therapy for patients with hepatocellular carcinoma(HCC).METHODS:From January 2007 to December 2010,49 consecutive HCC patients were listed for liver transplantation(UCSF criteria).The median waiting time for transplantation was 9.5 mo.Twenty-nine patients received transarterial chemoembolization(TACE) as a bringing therapy and 16 patients received no treatment before transplantation.Five patients received HIFU ablation as a bridging therapy.Another five patients with the same tumor staging(within the UCSF criteria) who received HIFU ablation but not on the transplant list were included for comparison.Patients were comparable in terms of Child-Pugh and model for end-stage liver disease scores,tumor size and number,and cause of cirrhosis.RESULTS:The HIFU group and TACE group showed no difference in terms of tumor size and tumor number.One patient in the HIFU group and no patient in the TACE group had gross ascites.The median hospital stay was 1 d(range,1-21 d) in the TACE group and two days(range,1-9 d) in the HIFU group(P < 0.000).No HIFU-related complication occurred.In the HIFU group,nine patients(90%) had complete response and one patient(10%) had partial response to the treatment.In the TACE group,only one patient(3%) had response to the treatment while 14 patients(48%) had stable disease and 14 patients(48%) had progressive disease(P = 0.00).Seven patients in the TACE group and no patient in the HIFU group dropped out from the transplant waiting list(P = 0.559).CONCLUSION:HIFU ablation is safe and effective in the treatment of HCC for patients with advanced cirrhosis.It may reduce the drop-out rate of liver transplant candidate. | Tan To Cheung Sheung Tat Fan See Ching Chan Kenneth SH Chok Ferdinand SK Chu Caroline R Jenkins Regina CL Lo James YY Fung Albert CY Chan William W Sharr Simon HY Tsang Wing Chiu Dai Ronnie TP Poon Chung Mau Lo | 2013 | World Journal of Gastroenterology2013，19，20： | 23 |
| 3 | P0tential of low- molecular chitosan as a DNAdelivery system : biocompatility, bo- dydistribution and ability to complex and protect DNA显示文摘 | Simon C W R Hanno V J K Ruth D | 1999 | Inter- national Journal of Pharrnacentics1999，178，： | 1 |
| 4 | Measurement of eddy diffusivity of momentum in film cooling flows with streamwise injection显示文摘 | Kaszeta R W Simon T W | 2000 | ASME Journal of Turbomachinery2000，122，： | 1 |
| 5 | The phase II urokinase-streptokinase pulmonary embolism trial: a national cooperative study显示文摘 | Sasahra A A Bell W R Simon T L Stengle J M Sherry S | 1975 | Thromb Diath Haemorrh1975，33，： | 1 |
| 6 | Li- pofuscin- and melanin-related fundus autofluorescence in pa- tients with ABCA 4-associated retinal dystrophies 显示文摘 | Simone K Ulrich K Bernhard HF Britta F Silke W Klaus R | 2009 | Am JOphthcdmol2009，147，8： | 1 |
| 7 | Quantum simulation of antiferromagnetic spin chains in an optical lattice 显示文摘 | Simon J Bakr W S Ma R | 2011 | Nature(London)2011，472，： | 1 |
| 8 | The effect of light on the senescence of detached cucumber cotyledons显示文摘 | Lewington R J Simon E W | 1969 | J Exp Bot1969，20，： | 1 |
| 9 | Novel three-phase AC-AC sparse matrix converters显示文摘 | Johann W Kolar Frank Schafmeister Simon D R | 2007 | IEEE Transactions on Power Electronics2007，22，5： | 1 |
| 10 | Combining anatomy and function the path to image fusion显示文摘 | Davide W Simon R | 2001 | Eur Radiol2001，11，10： | 1 |
| 11 | Spatial autocorrelation and autoregressive models in ecology 显示文摘 | LICHSTEIN J W SIMONS T R SHRINER S A | 2002 | Ecological Monographs2002，72，： | 1 |
| 12 | A random variance model for detection of differential gene expression in small microarray experiments显示文摘 | Wright G W Simon R | 2003 | Bioinformatics2003，19，18： | 1 |
| 13 | The biotic ligand model: a historical overview显示文摘 | Paul R P Joseph W G Simon A | 2002 | Comparative Biochemistry and Physiology Part C2002，133，12： | 1 |
| 14 | Changes in strain distribution of loaded proximal femora caused by different types of cementless femoral stems 显示文摘 | Decking R Puhl W Simon U | 2006 | Clin Biomech (Bristol Avon)2006，21，5： | 1 |
| 15 | Block copolymer-ceramic hybrid materials from organically modified ceramic precursors 显示文摘 | SIMON P F W ULRICH R SPIESS H W | 2001 | Chemical of Materials2001，13，10： | 1 |
| 16 | An empirical analysis of the dynamic relation between investmentgrade bonds and credit default swaps显示文摘 | BLANCO R SIMON B MARSH I W | 2005 | The Journal of Finance2005，60，5： | 1 |
| 17 | Neural Network Modeling of Salinity Variation in Apalachicola River显示文摘 | Huang W R Simon Foo | 2002 | Water Research2002，36，1： | 1 |
| 18 | Markov Models for Biogeography-Based Optimization 显示文摘 | Simon D Ergezer M Du D W Rarick R | 2011 | IEEE Transactions on Systems Man and Cybernetics--Part B: Cybernetics (S1083-4419) 20112011，41，1： | 1 |
| 19 | Analytical and Numerical Comparisons of Biogeography-based Optimization and Genetic Algorithms 显示文摘 | Simon D Rarick R Ergezer M Du D W | 2011 | Information Sciences (S0020-0255)2011，181，： | 1 |
| 20 | Is the startle reaction an emotion? 显示文摘 | Ekman P Friesen W V Simons R C | 1985 | Journal of Personality and Social Psychology1985，49，5： | 1 |
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