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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 | Gastroenteropancreatic neuroendocrine tumours显示文摘 | Irvin M Modlin Kjell Oberg Daniel C Chung Robert T Jensen Wouter W de Herder Rajesh V Thakker Martyn Caplin Gianfranco Delle Fave Greg A Kaltsas Eric P Krenning Steven F Moss Ola Nilsson Guido Rindi Ramon Salazar Philippe Ruszniewski Anders Sundin | 2008 | Lancet Oncology2008，，1： | 8 |
| 3 | Molecular and phenotypic characterization of genotypic Candida albicans subgroups and comparison with Candida dubliniensis and Candida stellatoidea 显示文摘 | McCullough M J Clemons K V Stevens D A | 1999 | J Clin Microbiol1999，37，2： | 2 |
| 4 | Survival after inflammatory bowel disease-associated colorectal cancer in the Colon Cancer Family Registry显示文摘AIM: To investigate the survival of individuals with colorectal cancer (CRC) with inflammatory bowel disease (IBD-associated CRC) compared to that of individuals without IBD diagnosed with CRC. METHODS: Epidemiologic, clinical, and follow-up data were obtained from the Colon Cancer Family Registry (Colon CFR). IBD-associated cases were identified from self-report of physician diagnosis. For a subset of participants, medical records were examined to confirm self-report of IBD. Cox proportional hazards regression was applied to estimate adjusted hazard ratios (aHR) and 95%CI of mortality, comparing IBD-associated to non-IBD-associated CRC, adjusted for age at CRC diagnosis, sex, Colon CFR phase, and number of prior endoscopies. Following imputation to complete CRC stage information, adjustment for CRC stage was examined. RESULTS: A total of 7202 CRC cases, including 250 cases of IBD-associated CRC, were analyzed. Over a twelve year follow-up period following CRC diagnosis, 2013 and 74 deaths occurred among non-IBD associated CRC and IBD-associated CRC patients, respectively. The difference in survival between IBD-associated and non-IBD CRC cases was not statistically significant (aHR = 1.08; 95%CI: 0.85-1.36). However, the assumption of proportional hazards necessary for valid inference from Cox regression was not met over the entire follow-up period, and we therefore limited analyses to within five years after CRC diagnosis when the assumption of proportional hazards was met. Over this period, there was evidence of worse prognosis for IBD-associated CRC (aHR = 1.36; 95%CI: 1.05-1.76). Results were similar when adjusted for CRC stage, or restricted to IBD confirmed in medical records. CONCLUSION: These results support the hypothesis that IBD-associated CRC has a worse prognosis than non-IBD-associated CRC. | Scott V Adams Dennis J Ahnen John A Baron Peter T Campbell Steven Gallinger William M Grady Loic LeMarchand Noralane M Lindor John D Potter Polly A Newcomb | 2013 | World Journal of Gastroenterology2013，19，21： | 2 |
| 5 | Polyethylene wear debris and long-term clinical failure of the Charite disc prosthesis: A study of 4 patients 显示文摘 | Andre V O Steven M Filip S | 2007 | Spine2007，32，2： | 1 |
| 6 | Chitosan as antimicrobial agent: applications and mode of action 显示文摘 | Rabea E I Badawy M E T Stevens C V | 2003 | Biomacromolecules2003，4，： | 1 |
| 7 | Prenylfavonoids from Humulus lupulus 显示文摘 | Stevens J F Ivancic M Hsu V L | 1997 | Phytochemistry1997，44，8： | 1 |
| 8 | Computational effi-ciency and validation of bi-directional evolutionary structural optimization显示文摘 | Young V Steven G P | 2000 | Computer methods in applied mechanics and engineering2000，189，： | 1 |
| 9 | Compu- tational efficiency and validation of bi-directionaI evo- lutionary structural optimisation显示文摘 | Querin O M Young V Steven G P Xie Y M | 2000 | Computer Meth- ods in Applied Mechanics and Engineering2000，189，： | 1 |
| 10 | Computational efficiency and validation of bi-direetional evolutionary structural optimization 显示文摘 | Querin O M Young V Steven G P Xie Y M | 2000 | Computer Methods in Applied Mechanics and Engineering2000，189，： | 1 |
| 11 | Chitosan as antimicrobial agent:applications and mode of action 显示文摘 | Rabea E I Badawy M E T Stevens C V | 2003 | Biomacromolecules2003，24，： | 1 |
| 12 | Aldose reductase inhi- bition counter-acts nitrosative stress and poly (ADP-ribose) poly- merase activation in diabetic rat kidney and high-glucose-exposed human mesanglal cells 显示文摘 | Drel V R Pacher P Stevens M J el al | 2006 | Free Radic Biol Med2006，40，8： | 1 |
| 13 | Chitosan as antimicrobial agent: Applications and mode of action 显示文摘 | Rabea E I Badawy M E T Stevens C V | 2003 | Biomacromolecules2003，4，： | 1 |
| 14 | Scaling multiple-point statistics to different univariate proportions显示文摘 | Ortiz J M Steven L Clayton V D | 2007 | Computers & Geosciences2007，33，： | 1 |
| 15 | The First Structure of UDP-Glucose Dehydrogenase Reveals the Catalytic Residues Necessary for the Two-fold Oxidation 显示文摘 | Robert E C Steven C M lvo V R | 2000 | Biochemistry2000，39，23： | 1 |
| 16 | Pyrazolopyridines as p38 kinase inhibitors显示文摘 | Stevens K L Jung D V Alberti M J | 2005 | Organic Letters2005，7，21： | 1 |
| 17 | Chitosan as antimicrobial agent: applications and mode of action 显示文摘 | Rabea E I Badawy M E T Stevens C V | 2003 | Biomacromolecules2003，4，6： | 1 |
| 18 | Phytosiderophore release from nodal,primary,and complete root systems in maize显示文摘 | Bernards M L Jolley V D Stevens W B | 2002 | Plant Soil2002，241，1： | 1 |
| 19 | Molecular and phenotypic characterization of genotypic Candida albicans subgroups and comparison with Candida dubliniensis and Candida stellatoidea显示文摘 | Mccullough M J Clemons K V Stevens D A | 1999 | J Clin Microbiol1999，37，2： | 1 |
| 20 | Apremilast: a novel PDE4 inhibitor in the treatment of autoimmune and inflammatory diseases 显示文摘 | Schett G Sloan V S Stevens R M | 2010 | Ther Adv Musculoskelet Dis2010，2，5： | 1 |
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