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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 | Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience显示文摘AIM To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a real world Australian tertiary care setting.METHODS We performed a retrospective analysis of treatment outcomes among treatment-na?ve and treatment-experienced patients receiving a minimum 3 mo tenofovir therapy through St Vincent's Hospital Melbourne, Australia. We included patients receiving tenofovir [tenofovir disoproxil fumarate(TDF)] monotherapy, as well as patients treated with TDF in combination with a second antiviral agent. Patients were excluded if they demonstrated human immune-deficiency virus/hepatitis C virus/hepatitis delta virus coinfection or were less than 18 years of age. We considered virological and biochemicalresponse, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus(HBV) DNA using sensitive assays; biochemical response was determined via serum liver function tests; histological response was determined from liver biopsy and fibroscan; safety analysis focused on glomerular renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/m L. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen(HBe Ag)/HB surface antigen loss and seroconversion over time.RESULTS Ninety-two patients were identified who fulfilled the enrolment criteria. Median follow-up was 26 mo(range 3-114). Mean age was 46(24-78) years, 64(70%) were male and 77(84%) were of Asian origin. 55(60%) patients were treatment-na?ve and 62 patients(67%) were HBe Ag-negative. Complete virological suppression was achieved by 45/65(71%) patients at 12 mo, 37/46(80%) at 24 mo and 25/28(89%) at 36 mo. Partial virological response(HBV DNA 20-2000 IU/m L) was achieved by 89/92(96.7%) of patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level(OR = 0.897, 95%CI: 0.833-0.967, P = 0.0046) and HBe Ag positive status(OR = 0.373, 95%CI: 0.183-0.762, P = 0.0069). There was no difference in response comparing treatment-na?ve and treatment-experienced patients. Three episodes of virological breakthrough occurred in the setting of noncompliance. Tenofovir therapy was well tolerated.CONCLUSION Tenofovir is an efficacious, safe and well-tolerated treatment in an Australian real-world tertiary care setting. Our data are similar to the reported experience from registration trials. | Grace C Lovett Tin Nguyen David M Iser Jacinta A Holmes Robert Chen Barbara Demediuk Gideon Shaw Sally J Bell Paul V Desmond Alexander J Thompson | 2017 | World Journal of Hepatology2017，9，1： | 7 |
| 3 | Magnetic field effects on the binding energy of hydrogen impurities in quantum dot with parabolic confinements 显示文摘 | NGUYEN V L VGUYEN M T NGUYEN T D | 2000 | Physica B2000，292，： | 2 |
| 4 | IL 28 B genotype is not useful for predicting treatment outcome in A sian chronic hepatitis B patients treated with pegylated interferon‐α显示文摘 | Jacinta A Holmes Tin Nguyen Dilip Ratnam Neel M Heerasing Jane V Tehan Sara Bonanzinga Anouk Dev Sally Bell Stephen Pianko Robert Chen Kumar Visvanathan Rachel Hammond David Iser Ferry Rusli William Sievert Paul V Desmond D Scott Bowden Alexander J Thomps | 2013 | J Gastroenterol Hepatol2013，，5： | 2 |
| 5 | Computational fluid dynamics modeling of gas jets impinging onto liquid pools 显示文摘 | Anh V Nguyen Geoffrey M Evans | 2006 | Applied Mathematical Modelling2006，30，： | 1 |
| 6 | Nutri?ent-gene interaction: metabolic genotype-phenotype re?lationship显示文摘 | GO V L NGUYEN C T HARRIS D M | 2005 | TheJournal of Nutrition2005，135，12： | 1 |
| 7 | Air bubble and oil droplet interactions in centrifugal fields during air sparged hydrocyclone flotation显示文摘 | NIEWIADOMSKI M NGUYEN A V HUPKA J | 2007 | International Journal of Environment and Pollution2007，30，2： | 1 |
| 8 | The design of a piezostack-based active mount and application to a vibration control system 显示文摘 | Nguyen V Q Choi S M Han Y M | 2008 | Smart Materials and Structures2008，17，06： | 1 |
| 9 | Androgens activate mitogen-activated protein kinase signaling: Role in neuroprotection 显示文摘 | Nguyen T V Yao M Pike C J | 2005 | J Neurochem2005，94，6： | 1 |
| 10 | Neuraminidase inhibitor sus- ceptibility testing of influenza type B viruses in China during 2010 and 2011 identifies viruses with reduced susceptibility to oseltamivir and zanamivir显示文摘 | Wang D Sleeman K Huang W Nguyen H T LevineM Cheng Y Li X Tan M Xing X Xu X Klimov A I Gubareva L V Shu Y | 2013 | Antiviral Research2013，97，3： | 1 |
| 11 | Endostatin induces autophagy in endothelial cells by modulating Beclin 1 and heta-eatenin levels 显示文摘 | Nguyen T M Subramanian I V Xiao X | 2009 | J Cell Mol Med2009，13，9： | 1 |
| 12 | Prediction of viscosity of glu cose and calcium chloride solutions 显示文摘 | Bui A V Nguyen M H | 2004 | Journal of Food Engineering2004，62，4： | 1 |
| 13 | A Study on the Composite Dielectric Properties for an HTS Cable 显示文摘 | Kwag D S Nguyen V D Back S M | 2005 | IEEE Transactions on Applied Supercond - uctivity2005，15，2： | 1 |
| 14 | Merocyanine dyes with improved photostability显示文摘 | Toutchkine A Nguyen D V Hahn K M | 2007 | Organic letters2007，9，15： | 1 |
| 15 | Transplantation in Parkinson's disease:PET changes correlate with the amount of grafted tissue显示文摘 | Cochen V Ribeiro M J Nguyen JP | 2003 | Mov Disord2003，18，8： | 1 |
| 16 | Feasibility of tomotherapy to reduce cochlea radiation dose in patients with locally advanced nasopharyngeal cancer显示文摘 | Nguyen NP Ceizyk M Vinh-Hung V | 2012 | Tumori2012，98，6： | 1 |
| 17 | CBP60g and SARD1 play partially redundant critical roles in salicylic acid signaling 显示文摘 | Wang L Tsuda K Truman W Sato M Nguyen L V Katagiri F Glazebrook J | 2011 | The Plant Journal2011，67，6： | 1 |
| 18 | Advanced oxidation protein products as novel mediators of inflammation and monocyte activation in chronic renal failure 显示文摘 | Witko-Sarsat V Friedlander M Nguyen Khoa T | 1998 | Immunol1998，161，： | 1 |
| 19 | Development of a solar-powered passive ejector cooling system显示文摘 | Nguyen V M Riffat S B Doherty P S | 2001 | Applied Thermal Engineering2001，21，2： | 1 |
| 20 | Different expression and clinical role of S100A4 in serous ovarian carcinoma at different anatomic sites 显示文摘 | MAELANDSMO G M FLRENES V A NGUYEN M T | 2009 | Turnout Biol2009，30，1： | 1 |
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