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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 | Hepatocellular carcinoma: Review of disease and tumor biomarkers显示文摘Hepatocellular carcinoma(HCC) is a common malignancy and now the second commonest global cause of cancer death. HCC tumorigenesis is relatively silent and patients experience late symptomatic presentation. As the option for curative treatments is limited to early stage cancers, diagnosis in non-symptomatic individuals is crucial. International guidelines advise regular surveillance of high-risk populations but the current tools lack sufficient sensitivity for early stage tumors on the background of a cirrhotic nodular liver. A number of novel biomarkers have now been suggested in the literature, which may reinforce the current surveillance methods. In addition, recent metabonomic and proteomic discoveries have established specific metabolite expressions in HCC, according to Warburg's phenomenon of altered energy metabolism. With clinical validation, a simple and non-invasive test from the serum or urine may be performed to diagnose HCC, particularly benefiting low resource regions where the burden of HCC is highest. | Jin Un Kim Mohamed I F Shariff Mary M E Crossey Maria Gomez-Romero Elaine Holmes I Jane Cox Haddy K S Fye Ramou Njie Simon D Taylor-Robinson | 2016 | World Journal of Hepatology2016，8，10： | 13 |
| 3 | From blood to breath: New horizons for esophageal cancer biomarkers显示文摘Esophageal cancer is a lethal cancer encompassing adenocarcinoma and squamous cell carcinoma subtypes. The global incidence of esophageal cancer is increasing world-wide, associated with the increased prevalence of associated risk factors. The asymptomatic nature of disease often leads to late diagnosis and five-year survival rates of less than 15%. Current diagnostic tools are restricted to invasive and costly endoscopy and biopsy for histopathology. Minimally and non-invasive biomarkers of esophageal cancer are needed to facilitate earlier detection and better clinical management of patients. This paper summarises recent insights into the development and clinical validation of esophageal cancer biomarkers, focussing on circulating markers in the blood, and the emerging area of breath and odorant biomarkers. | Roger Yazbeck Simone E Jaenisch David I Watson | 2016 | World Journal of Gastroenterology2016，22，46： | 6 |
| 4 | Urinary nuclear magnetic resonance spectroscopy of a Bangladeshi cohort with hepatitis-B hepatocellular carcinoma: A biomarker corroboration study显示文摘AIM: To establish if a distinct urinary metabolic profile could be identified in Bangladeshi hepatitis-B hepatocellular carcinoma(HCC) patients compared to cirrhosis patients and controls. METHODS: Urine samples from 42 Bangladeshi patients with HCC(39 patients with hepatitis-B HCC), 47 with cirrhosis on a background of hepatitis B, 46 with chronic hepatitis B, and seven ethnically-matched healthy controls were analyzed using nuclear magnetic resonance(NMR) spectroscopy. A full dietary and medication history was recorded for each subject. The urinary NMR data were analyzed using principal component analysis(PCA) and orthogonal partial leastsquared discriminant analysis(OPLS-DA) techniques. Differences in relative signal levels of the most discriminatory metabolites identified by PCA and OPLSDA were compared between subject groups using an independent samples Kruskal-Wallis one-way analysis of variance(ANOVA) test with all pairwise multiple comparisons. Within the patient subgroups, the MannWhitney U test was used to compare metabolite levels depending on hepatitis B e-antigen(HBe Ag) status and treatment with anti-viral therapy. A BenjaminiHochberg adjustment was applied to acquire the level of significance for multiple testing, with a declared level of statistical significance of P < 0.05.RESULTS: There were significant differences in age(P < 0.001), weight(P < 0.001), and body mass index(P < 0.001) across the four clinical subgroups. Serum alanine aminotransferase(ALT) was significantly higher in the HCC group compared to controls(P < 0.001); serum α-fetoprotein was generally markedly elevated in HCC compared to controls; and serum creatinine levels were significantly reduced in the HCC group compared to the cirrhosis group(P = 0.004). A threefactor PCA scores plot showed clustering of the urinary NMR spectra from the four subgroups. Metabolites that contributed to the discrimination between the subgroups included acetate, creatine, creatinine, dimethyamine(DMA), formate, glycine, hippurate, and trimethylamine-N-oxide(TMAO). A comparison of relative metabolite levels confirmed that carnitine was significantly increased in HCC; and creatinine, hippurate, and TMAO were significantly reduced in HCC compared to the other subgroups. HBe Ag negative patients showed a significant increase in creatinine(P = 0.001) compared to HBe Ag positive patients in the chronic hepatitis B subgroup, whilst HBe Ag negative patients showed a significant decrease in DMA(P = 0.004) in the cirrhosis subgroup compared to HBe Ag positive patients. There were no differences in metabolite levels in HCC patients who did or did not receive antiviral treatment. CONCLUSION: Urinary NMR changes in Bangladeshi HCC were identified, corroborating previous findings from Egypt and West Africa. These findings could form the basis for the development of a cost-effective HCC dipstick screening test. | I Jane Cox Abil E Aliev Mary ME Crossey Mahvish Dawood Mamun Al-Mahtab Sheikh M Akbar Salimur Rahman Antonio Riva Roger Williams Simon D Taylor-Robinson | 2016 | World Journal of Gastroenterology2016，22，16： | 4 |
| 5 | Real-time quantitative PCR for toxoplasmosis diagnosis显示文摘 | ORDINAIRE I SIMON A FREALLE E | 2005 | Ann Biol Clin2005，63，1： | 1 |
| 6 | 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 |
| 7 | The HMMTOP transmembrane topology prediction server显示文摘 | Tusnady G E Simon I | 2001 | Bioinformatics2001，17，9： | 1 |
| 8 | Update on Helicobacter pylori treatment显示文摘 | Ables A Z Simon I Melton E R | 2007 | Am Fam Physician2007，75，3： | 1 |
| 9 | Prediction of transmembrane alpha-helices in procariotic membrane proteins: the Dense Alignment Surface method显示文摘 | CSERZO M Wallin E Simon I G | 1997 | Prot Eng1997，10，6： | 1 |
| 10 | Chaos game representation of protein structures显示文摘 | Fiser A Tusnady G E Simon I | 1994 | J Mol Graphics1994，183，： | 1 |
| 11 | Exciton simulations of optical spectra of the FMO complex from the green sulfur bacterium chlorobium tepidum at 6k 显示文摘 | Simone I E Michiel A D Robert J W | 1998 | J Plays Chem B1998，102，： | 1 |
| 12 | Genetic variation atthe NPC1L1 gene locus,plasma lipoproteins, and heartdisease risk in the elderly显示文摘 | Polisecki E Peter I Simon JS | 2010 | J Lipid Res2010，51，5： | 1 |
| 13 | The HMMTOP transmembrane topology prediction server显示文摘 | TUSNADY G E SIMON I | 2001 | Bioinformatics2001，17，9： | 1 |
| 14 | Relative contribution of LFA-1 and Mac-1 to neutrophil adhesion and migration显示文摘 | DING Z M BABENSEE J E SIMON S I | | J Immunol0，163，9： | 1 |
| 15 | Principles governing amino acid composition of integral membrane proteins: Application to topology prediction 显示文摘 | Tusn a dy G E Simon I | 1998 | J Mol Biol1998，283，： | 1 |
| 16 | Changes in mon- ocyte functions of astronauts 显示文摘 | Kaur I Simons E R Castro V A | 2005 | Brain Behav Immun2005，19，6： | 1 |
| 17 | The HMMTOP transmembrane topology prediction server 显示文摘 | TUSNADY G E SIMON I | 2001 | Bioinf Appl Note2001，17，9： | 1 |
| 18 | Prediction of transmembrane alpha-helices in procariotic membrane proteins: the Dense Alignment Surface method 显示文摘 | Cserzo M Wallin E Simon I | 1997 | Prot Eng1997，10，： | 1 |
| 19 | Chaos game representation of protein structure显示文摘 | Fiser A Tusnady G E Simon I | 1994 | J Mol Graph1994，12，4： | 1 |
| 20 | Neutrophil,not macrophage,infiltration precedes neointimal thickening in balloon-injured arteries显示文摘 | WELT F G EDELMAN E R SIMON D I | 2000 | Arterioscler Thromb Vasc Biol2000，20，12： | 1 |
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