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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 | Combined treatment of non-small cell lung cancer using radiotherapy and immunotherapy: challenges and updates显示文摘The efficacy of immunotherapy for advanced non-small cell lung cancer(NSCLC)remains unsatisfactory,as the majority of patients either do not experience an objective response or acquire secondary resistance.As a result,several methods to enhance the systemic efficacy of immunotherapy have been investigated,including a large area of active research by combining immunotherapy with radiation therapy(RT).Given the rapidly burgeoning concept of combining immunotherapy and RT for increasing therapeutic benefit,we review the progress in this field thus far and explore further avenues for enhancing this combination.This review commences with a discussion of the only two existing randomized trials(and a pooled analysis)showing that the addition of RT to immunotherapy improves the abscopal response rate,progression-free survival,and overall survival in metastatic NSCLC patients.We then discussed factors and biomarkers that may be associated with a proportionally greater benefit to additional RT,such as low programmed cell death protein ligand 1(PD-L1)status,tumor mutational burden(TMB),and patient’s immune function.Next,the implementation of RT to overcome immunotherapy resistance is discussed,including a mechanistic discussion and methods with which these mechanisms could be exploited.Lastly,the emerging role of low-dose RT is discussed,which may help to overcome inhibitory signals in the tumor stroma that limit T-cell infiltration.Taken together,given the current state of this rapidly expanding realm,these futuristic strategies may be reflected upon to further enhance the efficacy of immunotherapy for a wider group of patients. | Shijie Shang Jie Liu Vivek Verma Meng Wu James Welsh Jinming Yu Dawei Chen | 2021 | Cancer Communications2021，41，11： | 10 |
| 3 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | The Lancet2010，，9716： | 2 |
| 4 | Lymphopenia Association With Gross Tumor Volume and Lung V5 and Its Effects on Non-Small-Cell Lung Cancer Patient Outcomes显示文摘 | Chad Tang Zhongxing Liao Daniel Gomez Lawrence Levy Yan Zhuang Rediet A. Gebremichael David S. Hong Ritsuko Komaki James W. Welsh | 2014 | International Journal of Radiation Oncology, Biology, Physics2014，，： | 2 |
| 5 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | The Lancet2010，，9716： | 2 |
| 6 | Error-related hyperactivity of the anterior cingulate cortex in obsessive-compulsive disorder显示文摘 | Kate Dimond Fitzgerald Robert C. Welsh William J. Gehring James L. Abelson Joseph A. Himle Israel Liberzon Stephan F. Taylor | 2005 | Biological Psychiatry2005，，3： | 1 |
| 7 | Feeding Jejunostomy Tubes Placed During Esophagectomy: Are They Necessary?显示文摘 | James R. Fenton Edward J. Bergeron Michael Coello Robert J. Welsh Gary W. Chmielewski | 2011 | The Annals of Thoracic Surgery2011，，2： | 1 |
| 8 | Progress in the management of limited‐stage small cell lung cancer显示文摘 | Arya Amini Lauren A. Byers James W. Welsh Ritsuko U. Komaki | 2014 | Cancer2014，，6： | 1 |
| 9 | Assessment and Management of Acute Coronary Syndromes (ACS): A Canadian Perspective on Current Guideline-Recommended Treatment – Part 2: ST-Segment Elevation Myocardial Infarction显示文摘 | David H. Fitchett Pierre Theroux James M. Brophy Warren J. Cantor Jafna L. Cox Milan Gupta Heather Kertland Shamir R. Mehta Robert C. Welsh Shaun G. Goodman | 2011 | Canadian Journal of Cardiology2011，，6： | 1 |
| 10 | Does the Timing of Esophagectomy After Chemoradiation Affect Outcome?显示文摘 | Jae Y. Kim Arlene M. Correa Ara A. Vaporciyan Jack A. Roth Reza J. Mehran Garrett L. Walsh David C. Rice Jaffer A. Ajani Dipen M. Maru Manoop S. Bhutani James Welsh Edith M. Marom Stephen G. Swisher Wayne L. Hofstetter | 2012 | The Annals of Thoracic Surgery2012，，1： | 1 |
| 11 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | 2010 (9716)2010，，9716： | 1 |
| 12 | Selection requirements during verb generation: differential recruitment in older and younger adults显示文摘 | Jonas Persson Ching-Yune C. Sylvester James K. Nelson Kathryn M. Welsh John Jonides Patricia A. Reuter-Lorenz | 2004 | Neuroimage2004，，4： | 1 |
| 13 | Comparing the functional properties of the Hsp70 chaperones, DnaK and BiP显示文摘 | Jeanne Bonomo John P. Welsh Karthish Manthiram James R. Swartz | 2010 | Biophysical Chemistry2010，，1： | 1 |
| 14 | Risk of heart failure relapse in subsequent pregnancy among peripartum cardiomyopathy mothers显示文摘 | James D. Fett Karie L. Fristoe Serena N. Welsh | 2009 | International Journal of Gynecology and Obstetrics2009，，1： | 1 |
| 15 | Esophageal Cancer Dose Escalation Using a Simultaneous Integrated Boost Technique显示文摘 | James Welsh Matthew B. Palmer Jaffer A. Ajani Zhongxing Liao Steven G. Swisher Wayne L. Hofstetter Pamela K. Allen Steven H. Settle Daniel Gomez Anna Likhacheva James D. Cox Ritsuko Komaki | 2012 | International Journal of Radiation Oncology Biology Physics2012，，1： | 1 |
| 16 | American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) Practice Guideline for the Performance of Stereotactic Body Radiation Therapy显示文摘 | Louis Potters Brian Kavanagh James M. Galvin James M. Hevezi Nora A. Janjan David A. Larson Minesh P. Mehta Samuel Ryu Michael Steinberg Robert Timmerman James S. Welsh Seth A. Rosenthal | 2010 | International Journal of Radiation Oncology, Biology, Physics2010，，2： | 1 |
| 17 | Finite sample preperties of indirect nonparametric closed loop identification显示文摘 | JAMES S WELSH | 2002 | IEEE Transactions on Auto- matic Control2002，47，8： | 1 |
| 18 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | The Lancet . 2010 (9716)2010，，9716： | 1 |
| 19 | Finite sample preperties of indirect nonparametric closed loop identification显示文摘 | James S Welsh | 2002 | IEEE Transactions on Automatic Control2002，47，8： | 1 |
| 20 | Body Composition and Performance Capabilities Based on Protein Intake in Collegiate Dancers: A Pilot Study显示文摘 | Ann Frost Brown Christopher William Bach Giuliana De Almeida Shawn Leonard Tom Welsh Michael James Ormsbee | 2017 | Journal of Sports Science2017，5，4： | 0 |
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