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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 | International consensus statement on robotic hepatectomy surgery in 2018显示文摘The robotic surgical system has been applied in liver surgery. However,controversies concerns exist regarding a variety of factors including the safety,feasibility, efficacy, and cost-effectiveness of robotic surgery. To promote the development of robotic hepatectomy, this study aimed to evaluate the current status of robotic hepatectomy and provide sixty experts' consensus and recommendations to promote its development. Based on the World Health Organization Handbook for Guideline Development, a Consensus Steering Group and a Consensus Development Group were established to determine the topics, prepare evidence-based documents, and generate recommendations. The GRADE Grid method and Delphi vote were used to formulate the recommendations. A total of 22 topics were prepared analyzed and widely discussed during the 4 meetings. Based on the published articles and expert panel opinion, 7 recommendations were generated by the GRADE method using an evidence-based method, which focused on the safety, feasibility, indication,techniques and cost-effectiveness of hepatectomy. Given that the current evidences were low to very low as evaluated by the GRADE method, further randomized-controlled trials are needed in the future to validate these recommendations. | Rong Liu Go Wakabayashi Hong-Jin Kim Gi-Hong Choi Anusak Yiengpruksawan Yuman Fong Jin He Ugo Boggi Roberto I Troisi Mikhail Efanov Daniel Azoulay Fabrizio Panaro Patrick Pessaux Xiao-Ying Wang Ji-Ye Zhu Shao-Geng Zhang Chuan-Dong Sun Zheng Wu Kai-Shan Tao Ke-Hu Yang Jia Fan Xiao-Ping Chen | 2019 | World Journal of Gastroenterology2019，25，12： | 23 |
| 3 | Defective LPS signaling in C3H/HeJ and C57BL/10ScCr mice: mutations in Tlr4 gene显示文摘 | Poltorak A He X Smirnoval I | 1998 | Science1998，282，5296： | 2 |
| 4 | Association of NFKBIA polymorphism with colorectal cancer risk and prognosis in Swedish and Chinese populations显示文摘 | Gao J Pfeifer D He i J | 2007 | Scand J Gastroenterol2007，42，3： | 1 |
| 5 | Repression of Smad transcriptional activity by PIASy, an inhibitor of activated STAT 显示文摘 | Long J Matsuura I He D | 2003 | PNAS2003，100，17： | 1 |
| 6 | Schizophrenia shows aunique metabolomics signature in plasma 显示文摘 | He Y Yu Z Giegling I | 2012 | TranslPsychiatry2012，2，8： | 1 |
| 7 | Defective LPS signaling in C3H/ HeJ and C57BL/ 10ScCr mice: mutations in Tlr4 gene显示文摘 | Poltorak A He X Smirnova I | 1998 | Science1998，282，5396： | 1 |
| 8 | Defective LPS signaling in C3 I-I/HeJ and C57BL/10ScCr mice:mutations in TLR4 gene显示文摘 | Poltorak A He X Smimova I | 1998 | Science1998，282，5396： | 1 |
| 9 | Transforming growth factor beta inducible phosphorylation of Smad3 显示文摘 | Wang G Matsuura I He D | 2009 | J Bid Chem2009，284，15： | 1 |
| 10 | Vaginal birth after caesarean section: a cohort study investigating factors associated with its uptake and success显示文摘 | Knight HE Gurol-Urganci I van der Meulen JH | 2014 | BJOG2014，121，2： | 1 |
| 11 | Nanostructured poly(4-methyl- 2 - pentyne)/silica hybrid membranes for gas separation显示文摘 | Pinnau I Morisato A | 2002 | Desalination2002，146，： | 1 |
| 12 | Epigenetic alteration of the Writ inhibitory factor-1 promoter occurs early in the carcinogenesis of Barrett's esophagus 显示文摘 | Clement G Guilleret I He B | 2008 | Cancer Sci2008，99，1： | 1 |
| 13 | Defective LPS signaling in C3H/HeJ and C57BL/10ScCr mice: mutations in Tlr4 gene 显示文摘 | Poltorak A He X Smimova I Liu MY Van Huffel C Du X | 1998 | Science1998，282，5396： | 1 |
| 14 | Defective LPS signaling in C3H/HeJ and C57BL/10ScCr mice: mutation in Tlr4 gene 显示文摘 | Poltorak A He X Smirnoval I | 1998 | Science1998，282，： | 1 |
| 15 | Genetic and physical mapping of the LPS locus: identification of the toll-4 receptor as a candidate gene in the critical region显示文摘 | Poltorak A Smirnoval I He X | 1998 | Blood Cells Mol Dis1998，24，3： | 1 |
| 16 | Defective LPS signaling in C3H/HeJ and C57BL/10ScCr mice:mutations in Tlr4 gene显示文摘 | Poltorak A He X Smirnova I | 1998 | Science1998，282，： | 1 |
| 17 | Vascular endothelial cell growth factor receptor 3-mediated activation of lymphatic endothelium is crucial for tumor cell entry and spread via lymphatic vessels 显示文摘 | He Y Rajantie I Pajusola K | 2005 | Cancer Res2005，65，11： | 1 |
| 18 | Vascular endothelial cell growth factor receptor 3-mediated activation of lymphatic endothelium is crucial for tumor cell entry and spread via lymphatic vessels显示文摘 | He Yulong Rajantie I Pajusola K | 2005 | Cancer Res2005，65，11： | 1 |
| 19 | Defective LPS signaling in C3H/HeJ and C57BL/10ScCr mice:mutations in TIr4 gene显示文摘 | Poltorak A He X Smirnova I | 1998 | Science1998，282，5396： | 1 |
| 20 | Seasonal variation of ionic species in fine particles at Qingdao,China显示文摘 | HU M HE I Y ZHANG Y H | 2002 | Atmos Environ2002，36，38： | 1 |
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