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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 | 腹腔镜外科学基础认证项目简介及其对中国外科医师的意义显示文摘腹腔镜外科学基础(FLS)项目是普通外科中第1个经过验证的操作和认知考核项目.FLS由美国胃肠内镜外科医师协会(SAGES)开发并得到美国外科医学委员会(ABS)的支持.ABS要求所有拟参加普通外科医师执业资格考试前必须通过FLS考试.在美国,普通外科医师执业资格考试是取得执业资格的第一步.本文回顾了FLS项目在美国取得的成功经验,并就该项目在中国推广标准化腹腔镜外科技术中的应用和获益进行了介绍. | Linda P Zhang Samuel R G Finlayson Allan Okrainec Steven D Schwaitzberg | 2014 | 中华消化外科杂志2014，13，9： | 5 |
| 3 | Hepatocellular carcinoma after Iocoregional therapy:Magnetic resonance imaging findings in falsely negative exams显示文摘AIM:To elucidate causes for false negative magnetic resonance imaging(MRI)exams by identifying imaging characteristics that predict viable hepatocellular carcinoma(HCC)in lesions previously treated with locoregional therapy when obvious findings of recurrence are absent.METHODS:This retrospective institutional review board-approved and Health Insurance Portability and Accountability Act-compliant study included patients who underwent liver transplantation at our center between 1/1/2000 and 12/31/2012 after being treated for HCC with locoregional therapy.All selected patients had a contrast-enhanced MRI after locoregional therapy within 90 d of transplant that was prospectively interpreted as without evidence of residual or recurrenttumor.Retrospectively,2 radiologists,blinded to clinica and pathological data,independently reviewed the pre transplant MRIs for 7 imaging features.Liver explan histopathology provided the reference standard,with clinically significant tumor defined as viable tumor≥1.0cm in maximum dimension.Fisher’s exact test was firs performed to identify significant imaging features.RESULTS:Inclusion criteria selected for 42 patients with 65 treated lesions.Fourteen of 42 patients(33%and 16 of 65 treated lesions(25%)had clinically significant viable tumor on explant histology.None o the 7 imaging findings examined could reliably and reproducibly determine which treated lesion had viable tumor when the exam had been prospectively read as without evidence of viable HCC.CONCLUSION:After locoregional therapy some treated lesions that do not demonstrate any MRI evidence o HCC will contain viable tumor.As such even patients with a negative MRI following treatment should receive regular short-term imaging surveillance because some have occult viable tumor.The possibility of occult tumo should be a consideration when contemplating any action which might delay liver transplant. | David Becker-Weidman Jesse M Civan Sandeep P Deshmukh Christopher G Roth Steven K Herrine Laurence Parker Donald G Mitchell | 2016 | World Journal of Hepatology2016，8，16： | 2 |
| 4 | Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias显示文摘 | Steven L Higgins John D Hummel Imran K Niazi Michael C Giudici Seth J Worley Leslie A Saxon John P Boehmer Michael B Higginbotham Teresa De Marco Elyse Foster Patrick G Yong | 2003 | Journal of the American College of Cardiology2003，，8： | 2 |
| 5 | Acapripoxvirus detection PCR and antibody ELISA based on the major antigen P32, the homolog of the vaccinia virus H3L gene显示文摘 | Hdine H G Stevens M P FoordAJ | 1999 | Immunol Methods1999，227，12： | 1 |
| 6 | Software Agents 显示文摘 | Michael R G Steven P K | 1998 | Communications of the ACM1998，37，48： | 1 |
| 7 | Evolutionary topology optimization for temperature reduction of heat conducting fields显示文摘 | Li Q Steven G P Xie Y M | 2004 | International Journal of Heat and Mass Transfer2004，47，23： | 1 |
| 8 | Vibration-Based model-dependent damage (delamination) identification and health monitoring for composite structures-a review 显示文摘 | Zou Y Tong L Steven G P | 2000 | Journal of Sound and vibration2000，230，2： | 1 |
| 9 | A capripoxvirus detection PCR and antibody ELISA based on the maior antigen P32, the homolog of the vaccinia virus H3L gene 显示文摘 | Heine H G Stevens M P Foord A J | 1999 | J Immune Meth1999，277，： | 1 |
| 10 | Evolutionary structural optimization(ESO)using a bi-directional algorithm显示文摘 | Steven G P Xie Y M | 1998 | Engi-neering Computation1998，15，8： | 1 |
| 11 | A simple evolutionary procedure for structural optimization显示文摘 | XIE Y M STEVEN G P | 1993 | Computers & Structures1993，49，5： | 1 |
| 12 | Vibration-based model-dependent damage (delamination) identification and health monitoring tor composite structures-a review 显示文摘 | Zou Y Tong L Steven G P | 2000 | Journal of Sound and Vibration2000，230，2： | 1 |
| 13 | A simple checkerboard suppression algorithm for evolutionary structural optimization 显示文摘 | Li O Steven G P Xie Y M | 2001 | Structural and Multidisciplinary Optimization2001，22，3： | 1 |
| 14 | A simple evolutionary procedure for structural optimization显示文摘 | Xie Y M Steven G P | 1993 | Computers and Structures1993，49，5： | 1 |
| 15 | A simple evolutionary procedure for structures optimization显示文摘 | XIE Yin-min STEVEN G P | 1993 | Computers and Struc- tures1993，49，5： | 1 |
| 16 | A simple evolutionary procedure for structures optimization显示文摘 | XIE Y M STEVEN G P | 1993 | Comput Struet1993，49，： | 1 |
| 17 | A simple evolutionary procedure for structural optimization 显示文摘 | Xie Y M Steven G P | 1993 | Computers and Structures1993，49，5： | 1 |
| 18 | Computational effi-ciency and validation of bi-directional evolutionary structural optimization显示文摘 | Young V Steven G P | 2000 | Computer methods in applied mechanics and engineering2000，189，： | 1 |
| 19 | Organosilicone surfactants as adjuvants for agroche- micals显示文摘 | Stevens P J G | 1993 | Pesticide Science1993，38，23： | 1 |
| 20 | Evolutionary structural optimization for dynamic problems显示文摘 | XIE Y M STEVEN G P | 1996 | Computers & Structures1996，58，6： | 1 |
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