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Clinical utilities and end-user experience of pharmacogenomics:39 mo of clinical implementation experience in an Australian hospital setting

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World Journal of Medical Genetics 2023年第4期11卷 39-50页

作者： Rosalind Moxham Andrew Tjokrowidjaja Sophie Devery Renee Smyth Alison McLean Darren M Roberts Kathy h C Wu Clinical Genomics St Vincent's HospitalNSWSydney 2010Australia School of Clinical Medicine Faculty of Medicine and HealthUniversity of New South WalesNSWSydney 2031Australia Clinical Pharmacology Drug Health ServicesRoyal Prince Alfred HospitalNSWSydney 2050Australia School of Medicine University of Notre Dame AustraliaNSWSydney 2010Australia Discipline of Genetic Medicine University of SydneyNSWSydney 2006Australia

BACKGROUND Pharmacogenomics(PG)testing is under-utilised in *** research provides Australia-specific data on the perspectives of patients who have had PG testing and those of the clinicians involved in their care,with the aim to inform wider adoption of PG into routine clinical *** To investigate the frequency of actionable drug gene interactions and assess the perceived utility of PG among patients and *** We conducted a retrospective audit of PG undertaken by 100 patients at an Australian public hospital genetics service from 2018 to *** electronic surveys we compared and contrasted the experience,understanding and usage of results between these patients and their *** Of 100 patients who had PG,84% were taking prescription medications,of which 67% were taking medications with actionable drug-gene ***-five out of 81 invited patients and 17 out of 89 invited clinicians completed the ***-eight percent of patients understood their PG results and 48% had medications changed following *** patient-clinician surveys showed patient-perceived utility and experience was positive,contrasting their clinicians’hesitancy on PG adoption who identified insufficient education/training,lack of clinical support,test turnaround time and cost as barriers to *** Our dichotomous findings between the perspectives of our patient and clinician cohorts suggest the uptake of PG is likely to be driven by patients and clinicians need to be prepared to provide information and guidance to their patients.

关键词： Pharmacogenomics testing Clinical adoption Drug gene interactions Clinician perspectives Patient perspectives

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POISONS: ThEIR ISOLATION AND IDENTIFICATION. By Frank Bamford. Second edition revised by C. P. Stewart, with a foreword by Professor sydney Smith. VIII + 304 pp. 23 illustrations. London: Churchill, 1947.

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中华医学杂志(英文版) 1949年第2期67卷 118-118页

作者： K. h. L.

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钠-葡萄糖共转运蛋白-2抑制剂或胰高血糖素样肽-1受体激动剂治疗成人2型糖尿病:临床实践指南

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英国医学杂志中文版 2021年第9期24卷 523-531页

作者： Sheyu Li Per Olav Vandvik Lyubov Lytvyn Gordon h Guyatt Suetonia C Palmer Rene Rodriguez-Gutierrez Farid Foroutan Thomas Agoritsas Reed A C Siemieniuk Michael Walsh Lawrie Frere David J Tunnicliffe Evi V Nagler Veena Manja Bjφrn Olav Asvold Vivekanand Jha Mieke Vermandere Karim Gariani Qian Zhao Yan Ren Emma Jane Cartwright Patrick Gee Alan Wickes Linda Fems Robin Wright Ling Li Qiukui hao Reem A Mustafa 无郭鹤鸣(译) Chengdu China Chinese Evidencebased Medicine Center Cochrane China Center and MAGIC China CenterWest China HospitalSichuan UniversityChengduChina University of Oslo OsloNorway MAGIC Evidence Ecosystem Foundation Department of health Research Methods Evidence and ImpactMcMaster UniversityHamiltonONCanada Department of Medicine McMaster UniversityHamiltonONCanada Department of Medicine University of OtagoChristchurchNew Zealand Plataforma INVEST Medicina UANL-KER Unit(KER Unit Mexico) Subdireccion de InvestigacionUniversidad Autonoma de Nuevo LeonMonterrey64460Mexico Knowledge and Evaluation Research Endocrinology Mayo ClinicRochesterMN55905USA Endocrinology Division Department of Internal MedicineUniversity Hospital"Dr.Jose E.Gonzalez"Universidad Autonoma de Nuevo LeonMonterrey64460Mexico Ted Rogers Center for heart Research Canada Service of Endocrinology DiabetesNutrition and Patient Therapeutic EducationGeneva University HospitalsGenevaSwitzerland Newbridge Surgery BathUK sydney School of Public health The University of SydneySydneyAustralia Centre for Kidney Research The Children's Hospital at WestmeadSydneyAustralia Renal Division Ghent University HospitalBelgium University of California Davis USA Department of Endocrinology Clinic of MedicineSt Olavs HospitalTrondheim University HospitalTrondheimNorway K.G.Jebsen Center for Genetic Epidemiology Department of Public Health and NursingNTNUNorwegian University of Science and TechnologyTrondheimNorway The George Institute for Global health UNSWIndia School of Public health Imperial CollegeLondonUK Prasanna School of Public health Manipal Academy of Higher EducationManipalIndia Department of Public health and Primary Care KU LeuvenLeuvenBelgium International Medical Center/Ward of General Practice West China HospitalSichuan UniversityChengduChina London UK Founder&CEhD iAdvorateInc.VirginiaPatient partner Patient partner The Center of Gerontology and Geriatrics/National Clinical Research Center for Geriatr

临床问题对于存在不同心血管风险及肾脏结局的2型糖尿病患者,在原有生活方式干预和/或其他降糖药物的基础上加用钠-葡萄糖共转运蛋白2(SGLT-2)抑制剂和胰高血糖素样肽1(GLP-1)受体激动剂的获益及风险是什么?现行做法几十年来,2型糖尿病... 详细信息

临床问题对于存在不同心血管风险及肾脏结局的2型糖尿病患者,在原有生活方式干预和/或其他降糖药物的基础上加用钠-葡萄糖共转运蛋白2(SGLT-2)抑制剂和胰高血糖素样肽1(GLP-1)受体激动剂的获益及风险是什么?现行做法几十年来,2型糖尿病的治疗决策都以控制血糖为主导。SGLT-2抑制剂和GLP-1受体激动剂在传统观念中常被用于二甲双胍治疗后血糖仍控制不佳的患者。目前这一现状已经发生了改变,这得益于多项临床研究结果。研究显示SGLT-2抑制剂和GLP-1受体激动剂拥有独立于药物降糖作用之外的对于动脉粥样硬化性心血管病(CVD)和慢性肾脏病(CKD)的获益。建议本指南阐述了针对不同风险分层的成人2型糖尿病患者使用SGLT-2抑制剂或GLP-1受体激动剂的建议。•伴有3种或更少的心血管风险因素且不存在CVD或CKD:不建议启动SGLT-2抑制剂或GLP-1受体激动剂治疗。(推荐等级:弱)•伴有3种以上心血管风险因素且不存在CVD或CKD:建议启动SGLT-2抑制剂治疗,不建议启动GLP-1受体激动剂治疗。(推荐等级:弱)•已经存在CVD或CKD:建议启动SGLT-2抑制剂治疗和GLP-1受体激动剂治疗。(推荐等级:弱)•已经存在CVD和CKD:建议启动SGLT-2抑制剂治疗(推荐等级:强)和GLP-1受体激动剂治疗。(推荐等级:弱)•对于那些想要进一步降低CVD和CKD结局风险的患者:推荐优先启用SGLT-2抑制剂治疗而非GLP-1受体激动剂治疗。(推荐等级:弱)这项指南是如何制订的一个由患者、临床医生和方法学家共同组成的国际小组提出了这些推荐意见。这些推荐意见基于可信度较高的指南的标准,并使用GRADE分级方法进行评估。该小组采用了息者个体化的观点。证据一项关于获益与风险的系统综述和网络meta分析(764项随机对照研究,包括421346例参与者)发现SGLT-2抑制剂和GLP-1受体激动剂可以降低总体死亡率、心肌梗死发生率、终末期肾病或肾衰竭的发生率(中等至高等质量的证据)。在不同的亚组中这些药物对卒中、因心力衰竭所致住院和其他主要不良事件有不同的影响。药物绝对获益的程度因患者个体风险的不同有很大的差异。(例如,对于接受了超过5年药物治疗的1000例患者,在最低风险人群中死亡人数减少了5人,在最高风险人群中死亡人数减少了48人)。一项关于预后的综述确认了14种风险预测模型,其中一种(RECODe)在证据总结中报告了大部分基线风险评估数据,小组利用该模型以支持风险分层的建议。考虑到患者的价值观及个体差异,指南推荐的支撑证据包括一项对已发表论文的系统综述、一项患者焦点小组研究、一项临床问题总结,以及一项指南调查。指南解读我们依据不同的CVD和CKD风险水平,综合考虑获益、风险和其他因素的平衡,以及每一个风险组别的实际问题,来对推荐意见进行分层。本指南强烈建议CVD和CKD患者使用SGLT-2抑制剂治疗,这说明专家组认为其具有显著的获益。而对于其他成人2型糖尿病患者,推荐等级较弱,这说明专家组想要在获益、风险及治疗花费上取得一个更好的平衡。临床医生通过该指南可以使用可靠的风险计算模型,如RECODe,来明确其患者的个体心血管和肾脏疾病风险。医患交互式总结临床证据和制订决策有助于患者知晓治疗选择,包括进行共同决策。2型糖尿病人群(全球患病率不断增长1-2)正面临着不断增加的心血管疾病、肾脏病和其他并发症的风险3。数十年来,2型糖尿病的管理始终以控制血糖及糖化血红蛋白(hbA1c)为治疗目标4-5,但是,最近的高质量随机对照研究已经对这种以血糖为中心的治疗模式发起了挑战。研究结果显示,强化血糖控制未必会降低大血管不良事件,它还可能带来不利影响监管机构现在要求新型糖尿病药物必须证明其具有心血管和肾脏获益才能获得批准。对两类新药--钠-葡萄糖共转运蛋白2(SGLT-2)抑制剂和胰高血糖素样肽1(GLP-1)受体激动剂(见框图1)的临床试验结果显示,在现有治疗方案(常规治疗)之上加用这些药物,对死亡、心肌梗死、卒中、心力衰竭和肾脏的结局(如进展为终末期肾病)都有获益8-12。

关键词：胰高血糖素样肽1 终末期肾病临床研究结果心血管风险 meta分析临床试验结果临床证据控制血糖

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英国征收糖税实现最佳获益一年内含糖软饮料的消费量下降

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英国医学杂志中文版 2021年第9期24卷 481-482页

作者： Jason h Y Wu Kent Buse 解夕黎(译) The George Institute for Global health UNSWSydneyAustralia The George Institute for Global health Imperial CollegeLondonUK 中国医科大学公共卫生学院

过量摄入游离糖是导致膳食相关疾病(包括蛀牙、2型糖尿病、肥胖和心血管疾病)的主要因素1。含糖饮料(sugar sweetened beverages)是全球膳食中游离糖摄入的重要来源,但并无任何营养价值,这使其成为公共卫生干预措施的理想目标2-4。世界... 详细信息

过量摄入游离糖是导致膳食相关疾病(包括蛀牙、2型糖尿病、肥胖和心血管疾病)的主要因素1。含糖饮料(sugar sweetened beverages)是全球膳食中游离糖摄入的重要来源,但并无任何营养价值,这使其成为公共卫生干预措施的理想目标2-4。世界卫生组织建议各国政府对含糖饮料征税,并将其作为综合应对政策的一部分5,目前全球约有50个司法管辖区采取相应措施6。

关键词：游离糖含糖饮料软饮料心血管疾病营养价值过量摄入综合应对

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胆固醇酯转移蛋白结构与功能的透射电子显微镜研究

胆固醇酯转移蛋白结构与功能的透射电子显微镜研究

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第七届全国液体和软物质物理学术会议

作者：张磊张胜利 Cavigiolio Giorgio 雷东升 Krauss Ronald M. Oda Michael Weisgraber Karl h. Rye Kerry-Anne Pownall henry J. Qiu Xiayang 任罡 Molecular Foundry Lawrence Berkeley National LaboratoryBerkeleyCA 94720USA Department of Biochemistry and Biophysics University of CaliforniaSan FranciscoCA 94158USA 西安交通大学理学院应用物理系 Children's hospital Oakland Research Institute OaklandCA 94609USA Gladstone Institute of Neurological Disease University of CaliforniaSan FranciscoCA 94158USA Lipid Research Group The Heart Research InstituteSydneyNSW2050Australia Faculty of Medicine University of SydneyNSW2060Australia Department of Medicine Baylor College of MedicineHoustonTX 77030USA Pfizer Global Research and Development GrotonCT 06430USA

＜正＞研究表明,人体中高水平的低密度脂蛋白胆固醇含量和低水平的高密度脂蛋白胆固醇含量是心血管疾病的主要危险因素。在胆固醇代谢过程中,胆固醇酯转移蛋白（CETP）造成了胆固醇酯从高密度脂蛋白到低密度/极低密度脂蛋白的传输,升高...

＜正＞研究表明,人体中高水平的低密度脂蛋白胆固醇含量和低水平的高密度脂蛋白胆固醇含量是心血管疾病的主要危险因素。在胆固醇代谢过程中,胆固醇酯转移蛋白（CETP）造成了胆固醇酯从高密度脂蛋白到低密度/极低密度脂蛋白的传输,升高了人体患心血管疾病的可能性。本文中,我们通过负染电子透射显微镜技术和分子动力学模拟手段,对CETP的结构与功能,以及与脂蛋白间的相互作用特点进行了研究。

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Low-protein diet accelerates wound healing in mice post-acute injury

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Burns & Trauma 2021年第1期9卷 339-350页

作者： Jonathan J.hew Roxanne J.Parungao Craig P.Mooney Julian K.Smyth Sarah Kim Kevin h.-Y.Tsai huaikai Shi Cassandra Chong Renee C.F.Chan Beba Attia Caroline Nicholls Zhe Li Samantha M.Solon-Biet David G.Le Couteur Stephen J.Simpson Marc G.Jeschke Peter K.Maitz Yiwei Wang Burns Research and Reconstructive Surgery ANZAC Research InstituteConcord HospitalUniversity of SydneySydneyAustralia 2139 Bone Biology Group ANZAC Research InstituteConcord HospitalUniversity of SydneySydneyAustralia 2139 Adrenal Steroids Laboratory ANZAC Research InstituteConcord HospitalUniversity of SydneySydneyAustralia 2139 Electron Microscopy Unit Anatomical PathologyConcord HospitalSydneyAustralia 2139 Burns Unit Concord Repatriation General HospitalConcordAustralia 2139 Ageing and Alzheimer Institute and ANZAC Research Institute Concord HospitalUniversity of SydneySydneyAustralia 2139 Charles Perkins Centre and School of Life and Environmental Sciences University of SydneyAustralia 2006 Sunnybrook Research Institute TorontoOntarioCanadaM4N 3M5 School of Pharmacy Nanjing University of Chinese MedicineNanjingPR China 210023

Background:Wound healing processes are influenced by macronutrient intake(protein,carbohydrate and fat).The most favourable diet for cutaneous wound healing is not known,although highprotein diets are currently favoured *** experimental study investigates the optimal macronutrient balance for cutaneous wound healing using a mouse model and the Geometric Framework,a nutrient modelling method,capable of analyzing the individual and interactive effects of a wide spectrum of macronutrient ***:Two adjacent and identical full-thickness skin excisions(1 cm^(2))were surgically created on the dorsal area of male C57BL/6 *** were then allocated to one of 12 high-energy diets that varied in protein,carbohydrate and fat *** select diets,wound healing processes,cytokine expression,energy expenditure,body composition,muscle and fat reserves were ***:Using the Geometric Framework,we show that a low-protein intake,coupled with a balanced intake of carbohydrate and fat is optimal for wound *** fed a low-protein diet progressed quickly through wound healing stages with favourable wound inflammatory cytokine expression and significantly accelerated collagen *** local processes were associated with an increased early systemic inflammatory response and a higher overall energy expenditure,related to metabolic changes occurring in key macronutrient reserves in lean body mass and fat ***:The results suggest that a low-protein diet may have a greater potential to accelerate wound healing than the current clinically used high-protein diets.

关键词： Wound healing Macronutrients Cutaneous Geometric Framework Mouse model Low-protein diet Nutrition

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Fonton术后的预防性抗凝措施

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世界核心医学期刊文摘（心脏病学分册） 2005年第12期1卷 46-46页

作者： Walker h. A. Gatzoulis M. A. 滕增辉 Adult Congenital heart Programme Department of CardiologyRoyal Brompton Hospital Sydney Street London SW3 6NP United Kingdom

Is it possible to advise either for or against prophylactic anticoagulation in patients following Fontan surgery? Certainly, the evidence suggests that thromboembolism is a major risk factor and it may therefore be considered reasonable to anticoagulate all patients. however, key information is missing regarding the safety and benefit from aspirin and warfarin treatment, as well as target international normalised ratio(INR) levels and timing of therapy. Consequently, if we are to subscribe to an evidence based approach, a blanket recommendation cannot be given. Nevertheless, if a high risk group is to be identified, patients with progressive right atrial dilatation and/or a history of atrial arrhythmia would appear, albeit anecdotally, to present the strongest case for prophylactic anticoagulation. Clearly, prospective controlled studies are required before definitive recommendations can be made.

关键词：房性心律失常目标水平术后抗凝治疗国际标准化比值循证治疗 Fonton 血栓栓塞

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卒中介入治疗培训指南：国际多学会共识文件

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国际脑血管病杂志 2017年第5期25卷 396-399页

作者： Lavine SD Cockroft K hoh B Bambakidis N Khalessi AA Woo h Riina h Siddiqui A hirsch JA Chong W Rice h Wenderoth J Mitchell P Coulthard A Signh TJ Phatorous C Khangure M Klurfan P ter Brugge K Iancu D Gunnarsson T Pongpech S Rodesch G Soderman M Taylor A Krings T Orbach D Picard L Suh DC Zheng hQ Jansen O Muto M Szikora I Pierot L Brouwer P Gralla J Renowden S Andersson T Fiehler J Turjman F White P Januel AC Spelle L Kulcsar Z Chapot R Biondi A Dima S Taschner C Szajner M Krajina A Sakai N Matsumaru Y Yoshknura S Ezura M Fujinaka T Iihara K Ishii A higashi T hirohata M hyodo A Ito Y Kawanishi M Kiyosue h Kobayashi E Kobayashi S Kuwayama N Matsumoto Y Miyachi S Murayama Y Nagata I Nakahara I Nemoto S Niimi Y Oishi h Satomi J Satow T Sugiu K Tanaka M Terada T Yamagami h Diaz O Lylyk P Jayaraman MV Patsalides A Gandhi CD Lee SK Abruzzo T Albani B Ansari SA Arthur AS Baxter BW Bulsara KR Chen M Almandoz JE Fraser JF heck DV hetts SW hussain MS Klucznik RP Leslie-Mawzi TM Mack WJ McTaggart RA Meyers PM Mocco J Prestigiacomo CA Pride GL Rasmussen PA Starke RM Sunenshine PJ Tarr RW Frei DF Pabo M Nogueira RG Zaidat OO Jovin T Linfante I Yavagal D Liebeskind D Novakovic R Pongpech S 许岩孙瑞郭芮兵 From the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Rolling Meadows IL USA American Society of Neuroradiology (ASNR) Oak Brook IL USA Asian Australasian Federation of lnterventional and Therapeutic Neuroradiology (AAFITN) Bali Indonesia Australian and New Zealand Society of Neuroradiobgy-Conjomt Committee for Recognition of Training in Interventional Neuroradiology (CCINR) representing the RANZCR (ANZSNR) ANZAN and NSA Sydney Australia Canadian Interventional Neuro Group (CING) Edmonton AB Canada World Federation of Interventional and Therapeutic Neuroradiology (WFITN) Gold Coast Australia European Society of Neuroradiology (ESNR) Milan Italy European Society of Minimally Invasive Neurologic Therapy (ESMINT) Nice France Japanese Society for Neuroendovascular therapy (JSNET) Okayama Japan Sociedad Ibero Latino Americana de Neuroradiologica (SILAN) Cartagena Colombia Society of Neurolnterventional Surgery (SNIS) Washington DC USA Society of Vascular and Interventional Neurology (SVIN) Brooklyn NY USA 南京大学医学院附属金陵医院(南京军区南京总医院)神经内科 210002 解放军第一0一医院(无锡太湖医院)神经内科无锡214004

1背景缺血性卒中是全球人口死亡和残疾的首要原因。很多急性大血管闭塞（emergent large vesselocclusion，ELVO）患者都会遗留长期残疾。事实上，这些颅内大动脉闭塞经常会导致大面积脑损伤，进而造成患者死亡或严重致残。

关键词：缺血性卒中培训指南介入治疗文件学会国际血管闭塞动脉闭塞

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当前和既往血压对老年人视网膜小动脉直径的影响

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世界核心医学期刊文摘（心脏病学分册） 2005年第1期1卷 54-54页

作者： Leung h. Jie J.W. Rochtchina E. 杜媛 Department of Ophthalmology University of SydneyWestmead Hospital Hawkesbury Road Westmead NSW 2145 Aus tralia

Objective: To examine the effects of current and past blood pressure on retina l arteriolar diameter in a general older population. Design: Cross-sectional an d longitudinal studies. Setting: Population-based cohort study of older residen ts from an area west of sydney, Australia. Participants: Two thousand three hund red and thirty-five individuals (n=2335) (aged≥54 years) who attended the 5-y ear follow-up Blue Mountains Eye Study during 1997-99. Main outcome measures: A computer-assisted method measured vessel diameters from digitized right eye r etinal photographs. The narrowest quintile of central retinal arteriolar equival ent or arteriole-to-venule ratio (AVR) defined generalized arteriolar narrowin g. Blood pressure was measured using a mercury sphygmomanometer. Results: After simultaneous adjustment for age, sex, body mass index, smoking and current or pa st blood pressure, elevated levels of both current and past blood pressure were associated with narrower retinal arterioles > and lower AVR > . Generalized arteriolar narrowing was associated with both current blood pressu re he highest versus lowest quintile of current DBP>> and past blood pressure (adjusted OR 1.7, 95%CI 1.1-2.6, for the highest versus lowest quintile of past DBP). h ypertension duration or control status at baseline had no additional effect on a rteriolar diameter after adjusting for current blood pressure. Conclusions: Our data document the independent effects of both current and past blood pressure on small vessel calibre in the retina, suggesting that retinal arteriolar narrowin g may result from the cumulative effects of long-standing hypertension.

关键词：动脉直径动脉狭窄程度血管直径高血压病程队列研究小动脉基线水平水银血压计老年居民吸烟状况

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培美曲塞加铂类联合或不联合帕博利珠单抗对初治转移性非鳞状NSCLC患者的疗效与安全性分析：KEYNOTE-189研究方案指定的最终分析

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中国肺癌杂志 2022年第6期25卷 443-456页

作者：周彩存 Delvys RODRíGUEZ-ABREU S.F.POWELL M.J.hOChMAIR S.GAD GEEL E.ESTEBAN E.FELIP G.SPERANZA F.De ANGELIS M.DóMINE S.Y.ChENG h.G.BISChOFF N.PELED M.RECK R.hUI E.B.GARON M.BOYER T.KURATA J.YANG M.C.PIETANZA F.SOUZA M.C.GARASSINO 同济大学附属上海市肺科医院肿瘤科 Medical Oncology Complejo Hospitalario Universitario Insular Materno-Infantil de Gran CanariaUniversidad de Las Palmas de Gran Canaria Oncology Sanford Health 4. Department of Respiratory and Critical Care MedicineKarl Landsteiner Institute of Lung Research and Pulmonary Oncology Thoracic Oncology Karmanos Cancer InstituteWayne State University Department of Medical Oncology Hospital Universitario Central de Asturias Medical Oncology Department Vall d'Hebron UniversityVall d'Hebron Institute of Oncology (VHIO) 8. Centre Integre de Cancerologie de la MontérégieH?pital Charles-Le Moyne 9. Medical Oncology DepartmentHospital Universitario Fundacidn Jiménez DiazIIS-FJD Sunnybrook health Sciences Centre Thoraxklinik Heidelberg Department of Oncology Shaare Zedek Medical Center LungenClinic Airway Research Center NorthGerman Center for Lung Research Department of Medical Oncology Westmead Hospital and University of Sydney Department of Medicine David Geffen School of Medicine at UCLA Department of Medical Oncology Chris O'Brien Lifehouse Department of Thoracic Oncology Kansai Medical University Hospital Merck & Co. Inc. Fondazione IRCCS Istituto Nazionale dei Tumori University of Chicago Medicine & Biological Sciences Knapp Center for Biomedical Discovery

背景在KEYNOTE-189此项Ⅲ期研究(NCT02578680)中,与安慰剂联合培美曲塞加铂类相比,帕博利珠单抗联合培美曲塞加铂类化疗(培美曲塞-铂类)显著改善了初治转移性非鳞状非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的总生存期(over... 详细信息

背景在KEYNOTE-189此项Ⅲ期研究(NCT02578680)中,与安慰剂联合培美曲塞加铂类相比,帕博利珠单抗联合培美曲塞加铂类化疗(培美曲塞-铂类)显著改善了初治转移性非鳞状非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的总生存期(overall survival,OS)和无进展生存期(progression-free survival,PFS)。本研究报告了研究方案指定的最终分析的疗效结局,包括从培美曲塞-铂类交叉至帕博利珠单抗治疗的患者,以及完成35个周期(约2年)帕博利珠单抗治疗组的疗效。方法符合条件的患者以2:1随机分配至帕博利珠单抗,每3周一次,200 mg (n=410)或安慰剂(n=206)(共35周期,约2年),加上4个周期的培美曲塞(500 mg/m~2)和由研究者选择的每3周顺铂(75 mg/m~2)或卡铂(曲线下面积5 mg/min/mL)治疗,随后使用培美曲塞直至疾病进展。若符合纳入标准,分配至安慰剂联合培美曲塞加铂类治疗的患者可在疾病进展时转向帕博利珠单抗治疗。主要研究终点为OS和PFS。结果中位随访31.0个月,无论PD-L1的表达水平如何,与安慰剂联合培美曲塞-铂类治疗相比,帕博利珠单抗联合培美曲塞-铂类治疗可使患者的OS[风险比(hazard ratio,hR)为0.56;95%可信区间(confidence interval,CI) 0.46-0.69]和PFS (hR=0.49;95%CI:0.41-0.59)显著获益。接受帕博利珠单抗联合培美曲塞-铂类治疗的患者客观缓解率(objective response rate,ORR)(48.3%vs 19.9%)和第二次/后续无进展生存期(PFS2;hR=0.50;95%CI:0.41-0.61)均得到改善。安慰剂联合培美曲塞-铂类组的84例患者(40.8%)交叉至帕博利珠单抗治疗组。72.1%的接受帕博利珠单抗联合培美曲塞-铂类的患者和66.8%的接受安慰剂联合培美曲塞-铂类的患者发生了3级-5级不良事件。56例患者完成了35个周期(约2年)的帕博利珠单抗治疗;ORR为85.7%,53例(94.6%)患者存活至数据截止时间。结论与安慰剂联合培美曲塞-铂类治疗相比,帕博利珠单抗联合培美曲塞-铂类可持续提高疗效,且安全性可控。该研究结果支持将帕博利珠单抗联合培美曲塞-铂类作为初治转移性非鳞状NSCLC患者的一线治疗方案。

关键词：帕博利珠单抗化疗非鳞状非小细胞肺癌

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