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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 | Role of observation of live cases done by Japanese experts in the acquisition of ESD skills by a western endoscopist显示文摘AIM:To evaluate the role of observation of experts performing endoscopic submucosal dissection(ESD)in the acquisition of ESD skills.METHODS:This prospective study is documenting the learning curve of one Western endoscopist.The study consisted of three periods.In the first period(preobservation),the trainee performed ESDs in animal models in his home institution in the United States.The second period(observation)consisted of visit to Japan and observation of live ESD cases done by experts.The observation of cases occurred over a 5-wk period.During the third period(post-observation),the trainee performed ESD in animal models in a similar fashion as in the first period.Three animal models were used:live40-50 kg Yorkshire pig,explanted pig stomach model,and explanted pig rectum model.The outcomes from the ESDs done in the animal models before and after observation of live human cases(main study intervention)were compared.Statistical analysis of the data included:Fisher’s exact test to compare distributions of a categorical variable,Wilcoxon rank sum test to compare distributions of a continuous variable between the two groups(pre-observation and post-observation),and Kruskal-Wallis test to evaluate the impact of lesion location and type of model(ex-vivo vs live pig)on lesion removal time.RESULTS:The trainee performed 38 ESDs in animal model(29 pre-observation/9 post-observation).The removal times post-observation were significantly shorter than those pre-observation(32.7±15.0 min vs 63.5±9.8 min,P<0.001).To minimize the impact of improving physician skill,the 9 lesions post-observation were compared to the last 9 lesions pre-observation and the removal times remained significantly shorter(32.7±15.0 min vs 61.0±7.4 min,P=0.0011).Regression analysis showed that ESD observation significantly reduced removal time when controlling for the sequence of lesion removal(P=0.025).Furthermore,it was also noted a trend towards decrease in failure to remove lesions and decrease in complications after the period of observation.This study did not find a significant difference in the time needed to remove lesions in different animal models.This finding could have important implications in designing training programs due to the substantial difference in cost between live animal and explanted organ models.The main limitation of this study is that it reflects the experience of a single endoscopist.CONCLUSION:Observation of experts performing ESD over short period of time can significantly contribute to the acquisition of ESD skills. | Peter V Draganov Myron Chang Roxana M Coman Mihir S Wagh Qi An Takuji Gotoda | 2014 | World Journal of Gastroenterology2014，20，16： | 3 |
| 3 | Personalising pancreas cancer treatment:When tissue is the issue显示文摘The treatment of advanced pancreatic cancer has not moved much beyond single agent gemcitabine until recently when protocols such as FOLFIRINOX(fluorouracil,leucovorin,irinotecan and oxaliplatin)and nab-paclitaxelgemcitabine have demonstrated some improved outcomes.Advances in technology especially in massively parallel genome sequencing has progressed our understanding of the biology of pancreatic cancer especially the candidate signalling pathways that are involved in tumourogenesis and disease course.This has allowed identification of potentially actionable mutations that may be targeted by new biological agents.The heterogeneity of pancreatic cancer makes tumour tissue collection important with the aim of being able to personalise therapies for the individual as opposed to a one size fits all approach to treatment of the condition.This paper reviews the developments in this area of translational research and the ongoing clinical studies that will attempt to move this into the everyday oncology practice. | Katrin M Sjoquist Venessa T Chin Lorraine A Chantrill Chelsie O'Connor Chris Hemmings David K Chang Angela Chou Marina Pajic Amber L Johns Adnan M Nagrial Andrew V Biankin Desmond Yip | 2014 | World Journal of Gastroenterology2014，20，24： | 2 |
| 4 | The rule of thumb of the permeability calculation by Φ, Ss and SWT, in the carbonate stone显示文摘 | Chilingazian G V Chang Jincai Bagrintseva K J | 1990 | Journal of Petroleum Science and Engineering1990，14，4： | 1 |
| 5 | Observations on changes in ultrasonically treated waste-activated sludge显示文摘 | Chu C P Chang B V Liao G S | 2001 | Wat Res2001，35，4： | 1 |
| 6 | Fundamental factors afecting biomass enzymatic reactivity 显示文摘 | CHANG V S HOLTZAPPLE M T | 2000 | Appl Biochem Biotech · nol2000，，848586： | 1 |
| 7 | Biodegradation of phenanthrene and pyrene fi-om mangrove sediment in subtropical Taiwan显示文摘 | CHANG B V CHANG I T YUAN S Y | 2008 | J environ sci health2008，43，3： | 1 |
| 8 | Bilater- al aldosterone-producing adenomas= differentiation from bilateral adrenal hyperplasia显示文摘 | WU V C CHUEH S C CHANG H W | 2008 | Q J M2008，101，： | 1 |
| 9 | Biodegradation of polycyclic aromatic hydrocarbons by a mixed culture显示文摘 | Yuan S Y Wei S H Chang B V | 2000 | Chemosphere2000，41，： | 1 |
| 10 | Dechlorination of pentachlorophenol in anaerobic sewage sludge显示文摘 | Chang B V Chiang C W Yuan S Y | 1998 | Cheosphere1998，36，3： | 1 |
| 11 | The effect of valproic acid on hepatic and plasma levels of 15-F(2t)-isoprostane in rats显示文摘 | Tong V Chang TK Chen J Abbott FS | 2003 | Free Radic Biol Med2003，34，11： | 1 |
| 12 | with ischemic heart disease显示文摘 | Pascei V etAssociatio of virrlent helicobacter pylori strains with is cthelin and calcitonin gene-related peptide in patients with essential hypertension of different blood pressure grades and their changes after felodipine treatment | 1998 | Circulation1998，97，： | 1 |
| 13 | Buckytubes and derivatives:their growth and implications for buckyball formation显示文摘 | DRAVID V P LIN X WANG X K YEE A KETTERSON J B CHANG R P H | 1993 | Science1993，259，： | 1 |
| 14 | Loss ofE-cadherin expression resulting from promoter hypermethylation in oral tongue carcinoma and its prognostic significance显示文摘 | Chang HW Chow V Lam KY | 2002 | Cancer2002，94，： | 1 |
| 15 | Dose-dependent protection of cardiac function by propofol during ischemia and early reperfusion in rats: effects on 15-Ftisoprostane formation显示文摘 | XIA Z GODIN D V CHANG T K | 2003 | Can J Physiol Pharmacol2003，8，1： | 1 |
| 16 | Association of eosinoph - ilic inflammation with esophageal food impaction in adults 显示文摘 | Desai T K Stecevic V Chang C H | 2005 | Gastrointest Endosc2005，61，7： | 1 |
| 17 | Free radicals scavenging activity of mushroom polysaccharide extracts显示文摘 | Liu F Ooi V E C Chang S T | 1997 | Life Sci1997，，60： | 1 |
| 18 | Light emitting diodes reliability review显示文摘 | CHANG M H DAS D VARDE P V | 2012 | Mieroeleetronics Re- liability2012，52，5： | 1 |
| 19 | Species variation in lignin显示文摘 | SARKANEN K V CHANG H M ERICSSON B | 1967 | Tappi1967，50，11： | 1 |
| 20 | Self-aligned UMOSFET's with a specific on-resistance of 1 mΩ;cm2显示文摘 | CHANG H-R BLACK R D TEMPLE V A K | 1987 | IEEE Trans Elec Dev1987，34，5： | 1 |
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