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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 | Software Project Management Approaches for Global Software Development: A Systematic Mapping Study显示文摘Global Software Development(GSD) is a well established field of software engineering with the benefits of a global environment. Software Project Management(SPM) plays a key role in the success of GSD. As a result, the need has arisen to study and evaluate the downsides of SPM for GSD, to thereby pave the way for the development of new methods, techniques, and tools with which to tackle them. This paper aims to identify and classify research on SPM approaches for GSD that are available in the literature, to identify their current weaknesses and strengths, and to analyze their applications in industry. We performed a Systematic Mapping Study(SMS) based on six classification criteria. Eighty-four papers were selected and analyzed. The results indicate that interest in SPM for GSD has been increasing since 2006. As a class of approaches, the most frequently reported methods(40%) are those used for coordination, planning, and monitoring, along with estimation techniques that can be used to better match a distributed project. SPM for GSD requires further investigation by researchers and practitioners, particularly with respect to cost and time estimations. These findings will help overcome the challenges that must to be considered in future SPM research for GSD, especially regarding collaboration and time-zone differences. | Manal El Bajta Ali Idri Joaquín Nicolás Ros José Luis Fernández-Alemán Juan Manuel Carrillo de Gea Félix García Ambrosio Toval | 2018 | Tsinghua Science and Technology2018，23，6： | 2 |
| 3 | An Improved Stator Flux Estimation in Steady-state Operation for Direct Torque Control of Induction Machine显示文摘 | Idris N R N Yatim A H M | 2002 | IEEE Trans on Industry Applications2002，38，1： | 1 |
| 4 | A divergent isolate of Tomato yellow leaf curl virus from Oman with an associated DNA beta satellite an evolutionary link between Asian and the Middle Eastren virus-satellite complexes显示文摘 | Klan A J Idris A M Al-Saady N A | 2008 | Virus Genes2008，36，： | 1 |
| 5 | Utilization of palm oil and palm products in shortenings and margarines 显示文摘 | IDRIS N A MAT S M | 2007 | Eur J Lipid Sci Technol2007，109，： | 1 |
| 6 | Antioxidative properties of Pandanus amaryllifolius leaf extracts in accelerated oxidation and deep frying studies显示文摘 | Fatihanim M N Suhaila M Idris N A | 2008 | Food Chemistry2008，110，2： | 1 |
| 7 | An improved stator flux estimation in steady-state operation for direct torque control of induction machines显示文摘 | IDRIS N R N YATIM A H M | 2002 | IEEE Transactions on Industry Applications2002，38，1： | 1 |
| 8 | An improved stator flux estimation in steady-state operation for direct torque control of induction machines显示文摘 | Idris N R N Yatim A H | 2002 | IEEE Transactions on Industry Applications2002，38，1： | 1 |
| 9 | Direct torque control with 5-level cascaded H-bridge multilevel Inverter for induction machines 显示文摘 | Nordin N M Idris N R N Azli N A | 2011 | IEEE Transactions on Power Electronics2011，11，2： | 1 |
| 10 | Screening rhizobacteria for biological control of Fusarium root and crown rot of sorghum in Ethiopia显示文摘 | Idris H A Labuschagne N Korsten L | | 0，，1： | 1 |
| 11 | A new torque and flux controller for direct torque control of induction machines显示文摘 | IDRIS N R N TOH C L | 2006 | IEEE Transactions on Industry Applications2006，42，6： | 1 |
| 12 | Contemporary semantic Web service framework显示文摘 | Mohebbi K Ibrahim S Idris N B | 2012 | International Journal on Web Service Computing2012，3，3： | 1 |
| 13 | An optimized switching strategy for quick dynamic torque control in DTC-Hysteresis-Based induction machines 显示文摘 | Jidin A Nik Idris N R Mohamed Yatim A H | 2011 | IEEE Transactions on Industrial Electronics2011，58，8： | 1 |
| 14 | Direct torque control of induction machines with constant switching frequency and reduced torque ripple显示文摘 | IDRIS N R N YATIM A H M | 2004 | IEEE Trans Ind Electron2004，51，4： | 1 |
| 15 | Studies of ENR-50 and LiN(S02CF3)2 electrolyte system 显示文摘 | ZAINAL N IDRIS R SABIRIN M N | 2012 | Advanced Materials Research2012，545，： | 1 |
| 16 | Kinetic Study of Utilizing Groundnut Shell as an Adsorbent in Removing Chromium and Nickel from Dye Effluent显示文摘 | IDRIS S IYAKA Y A DAUDA B E N | | 0，，： | 1 |
| 17 | Kinetic and regeneration studies ofphotocatalytic magnetic separable beads for chromium (VI) reduction under sunlight 显示文摘 | IDRIS A HASSAN N RASHID R NGOMSIK A F | 2011 | Journal of Hazardous Materials2011，186，： | 1 |
| 18 | An effective security interoperability archetype for secure multilevel databases显示文摘 | Awadelkarim A M Idris N B | 2006 | Asian Journal of Information Technology2006，5，4： | 1 |
| 19 | IGF-1-overexpressing mesenchymal stem cells accelerate bone marrow stem cell mobilization via paracrine activation of SDF-1 alpha/CXCR4 signaling to promote myocardial repair显示文摘 | HAIDER H JIANG S IDRIS N M | 2008 | Circ Res2008，103，11： | 1 |
| 20 | Total removal of heavy metal from mixed plating rinse wastewater 显示文摘 | Sapari N Idris A Hamid N H A | 1996 | Desalina- tion1996，106，13： | 1 |
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