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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 | Multivariate statistical analysis of clinicopathologic factors influencing survival of patients with bile duct carcinoma显示文摘AIM: To evaluate the influence of various clinicopathologicfactors on survival of patients with bile duct carcinoma aftercurative resection.METHODS: A retrospective analysis was made for 86 casesof bile duct carcinoma treated from January 1981 toSeptember 1995. Fifteen clinicopathologic factors possiblyinfluencing survival were selected. Independent variableswere first analyzed by univariate methods. Survival forvariable was estimated by the method of Kaplan and Meier.The variables that were statistically significant by univarlateanalysis were included in a multivariate analysis, which wereconfirmed using the Cox stepwise proportion hazard modelwith the help of SPSS 10.0 for Windows software.RESULTS: The overall cumulative survival rate was 72.6 %at 1 year, 32.4 % at 3 years, and 18.7 % at 5 years. Theresults of univariate analysis showed that the majorsignificant prognostic factors influencing survival of thesepatients were histological type of lesion, lymph nodemetastasis, pancreatic invasion, duodenal invasion, pedneuralinvasion, macroscopic vessel involvement, resected surgicalmargin and depth of cancer invasion (P=0.02, 0.02, 0.004,0.005, 0.01, 0.43, 0.03 and 0.04). Age, sex, location of tumor,size of tumor, macroscopic type of lesions, hepaticmetastasis, and hepatic invasion were not significantlyassociated with prognosis (P>0.05). Pancreatic invasion,perineural invasion and lymph node metastases were thethree most important prognostic factors by multivariateanalysis using the Cox proportional hazards model.CONCLUSION: Pancreatic invasion, pedneural invasion andlymph node metastases are the most important prognosticfactors for bile duct carcinoma after curative resection. | He, P Shi, JS Chen, WK Wang, ZR Ren, H Li, H | 2002 | World Journal of Gastroenterology2002，8，5： | 10 |
| 3 | Expression and release of IL-29 by mast cells and modulation of mast cell behavior by IL-29显示文摘 | He, S Zhang, H Chen, H Yang, H Huang, T Chen, Y Lin, J Wang, F Chen, X Li, TL Yang, P | 2010 | 南京医科大学学报(自然科学版)2010，30，11： | 6 |
| 4 | Effect of heating rate on pore structure of porous FeA1 material 显示文摘 | GAO H Y HE Y H SHEN P Z | 2008 | Powder Metallurgy2008，51，2： | 1 |
| 5 | Interfacial microstructure and mechanical properties of aluminium-zinc-coated steel joints made by a modified metal inert gas welding-brazing process显示文摘 | ZHANG H T FENG J C HE P HACKL H | 2007 | Materials Characterization2007，58，7： | 1 |
| 6 | Colloid Au-enhanced DNA immobilization for the dectrochemical detection of sequence-specific DNA显示文摘 | Xu C He P | 2001 | Journaof Electmanalytical Chemistry2001，510，12： | 1 |
| 7 | Thermal stability of recorded information at high densities显示文摘 | Charap S H Lu P L He Y J | 1997 | IEEE Trans Magn1997，33，1： | 1 |
| 8 | Mechanical alloying of immiscible elements:Al-Fe contrasted with Cu-Fe显示文摘 | Ma E He J H Schilling P J | 1997 | Physical Review B1997，55，9： | 1 |
| 9 | Location and migration of cations in Cu2+-adsorbed montmorillonite显示文摘 | H P He J G Guo X D Xie | 2001 | Environment International2001，26，： | 1 |
| 10 | Indicator free DNA hybridization detection by impedance measurement based on the DNA-doped conducting polymer film formed on the carbon nanotube modified electrode显示文摘 | Cai H Xu Y He P G | 2003 | Electroanalysis2003，15，： | 1 |
| 11 | Carbohydrates from Cynanchum otophyllum 显示文摘 | Zhao Y B Shen Y M He H P | 2004 | Carbohydrate Research2004，339，11： | 1 |
| 12 | An innovative design for using flexible printed coils for magnetostrictive-based longitudinal guided wave sensors in steel strand inspection显示文摘 | Tse P W Liu X C Liu Z H Wu B He C F Wang XJ | 2011 | Smart Materials and Structures2011，20，05： | 1 |
| 13 | Materials Science and Engineering A显示文摘 | Zhang H T He P Feng J C | 2006 | 425:2552006，425，： | 1 |
| 14 | Sol-Gel Synthesis and char- acterization of ytterbium silicate powders显示文摘 | Wen H Dong S He P | 2007 | Journal of the American Ceramic Society2007，90，： | 1 |
| 15 | Single-crystal- line sodium-doped p-type ZnO and ZnMgO nanowires via eombination of thin-film and nano techniques 显示文摘 | HE H P LIN S S YUAN G D | 2011 | Jour- nal of Physical Chemistry: C2011，115，39： | 1 |
| 16 | Adsorption and Dissociation of NO on Ir(l00) : A First-Principles Study 显示文摘 | He C Z Wang H Zhu P | 2011 | J Chem Phys2011，135，20： | 1 |
| 17 | 查看详情显示文摘 | Zhang J P Yang H P Han K L Deng W Q He G Z Lou N Q | | 0，，： | 1 |
| 18 | The TIL commissioning and performance显示文摘 | X Zhang W Zheng X Wei F Jing Z Sui K Zheng Q Xu X Yuan X Jiang L Yang P Ma M Li J Wang D Hu S He F Li Z Peng B Feng H Zhou L Guo X Li X Zhang J Su Q Zhu H Yu R Zhao C Ma H He D Fan W Zhang | 2008 | Journal of Physics: Conference Series2008，，3： | 1 |
| 19 | Microstructure,chemical and tribological investigations of MoxW1-xSy co-sputtered composite films显示文摘 | YIN G L HUANG P H YU Z HE D N TU J P | 2006 | Tribology Letters2006，22，1： | 1 |
| 20 | Thiazole-containing Tripodal Ligand:Synthesis,Characterization,and Interaction with Metal Ions and Matrix Metalloproteinases显示文摘 | He H S Linder D P Rodgers K R | 2004 | Inorg Chem2004，，： | 1 |
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