Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology

被引：6

作者：

Salgado, Roberto ^{[1
,2
]}

Solit, David B. ^{[3
]}

Rimm, David L. ^{[4
,5
]}

Bogaerts, Jan ^{[6
,24
]}

Canetta, Renzo

Lively, Tracy ^{[7
]}

Lyerly, Kim ^{[8
]}

Span, Paul N. ^{[9
]}

Bateman-House, Alison ^{[10
]}

Makady, Amr ^{[11
,26
]}

Bergmann, L. ^{[12
,13
]}

Nagai, Sumimasa ^{[14
,15
]}

Smith, Chris ^{[16
]}

Robson, Mark ^{[3
]}

Savage, Mary ^{[17
]}

Voest, Emile ^{[18
]}

Sweeney, Christopher ^{[19
]}

Lambin, Philippe ^{[20
,21
,33
]}

Thomas, Marlene ^{[22
]}

Harris, Lyndsay ^{[7
]}

Lacombe, Denis ^{[6
]}

Massard, Chistophe ^{[23
]}

Lyerly, Herbert K. ^{[25
]}

Yee, Laura ^{[7
]}

Rimm, David ^{[4
]}

Bateman-Houseaj, Alison ^{[10
]}

Bergmann, Lothar ^{[27
]}

Nagaiam, Sumimasa ^{[14
,15
]}

Thomasan, Marlene ^{[22
]}

Cree, Ian A. ^{[28
]}

Hopper, Shirley ^{[29
]}

Robson, Marc ^{[3
]}

Ingelman-Sundberg, Magnus ^{[30
]}

Maignen, Francois ^{[31
]}

Besse, Benjamin ^{[23
]}

Swierzewski, Rafal ^{[32
]}

Kiermaier, Astrid ^{[34
]}

Lacombex, Denis ^{[24
]}

Livelyad, Tracy ^{[7
]}

Massard, Christophe ^{[35
]}

Salgadobf, Roberto

Golfinopoulos, Vassilis ^{[24
]}

机构：

[1] GZA ZNA, Dept Pathol, Antwerp, Belgium

[2] Peter Mac Callum Canc Ctr, Div Res, Melbourne, Vic, Australia

[3] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[4] Yale Univ, Sch Med, Dept Pathol, New Haven, CT 06510 USA

[5] Yale Univ, Sch Med, Dept Med, New Haven, CT 06510 USA

[6] EORTC Headquarters, Brussels, Belgium

[7] NCI, Bethesda, MD 20892 USA

[8] Duke Univ, Durham, NC USA

[9] Radboud Univ Nijmegen, Med Ctr, Radiotherapy & Oncolmmunol Lab, Dept Radiat Oncol, Nijmegen, Netherlands

[10] NYU Langone Hlth, Div Med Eth, New York, NY USA

[11] Natl Healthcare Inst ZIN, Diemen, Netherlands

[12] Univ Hosp Frankfurt, Med Clin 2, Frankfurt, Germany

[13] Ambulantes Krebszentrum Frankfurt, Frankfurt, Germany

[14] Univ Tokyo Hosp, Translat Res Ctr, Tokyo, Japan

[15] PMDA, Tokyo, Japan

[16] Univ Cambridge, CRUK Cambridge Inst, Cambridge, England

[17] Merck, Whitehouse Stn, NJ USA

[18] Netherlands Canc Inst, Amsterdam, Netherlands

[19] Harvard Med Sch, Dana Farber Canc Inst, Boston, MA 02115 USA

[20] Grow Res Inst Oncol, D Lab, Dept Precis Med, Maastricht, Netherlands

[21] Grow Res Inst Oncol, M Lab, Dept Precis Med, Maastricht, Netherlands

[22] Roche, Basel, Switzerland

[23] Inst Gustave Roussy, Paris, France

[24] EORTC, Brussels, Belgium

[25] Duke Univ, Med Ctr, Durham, NC USA

[26] Interne Geneeskunde Sect Zorg Zorginst Nederlands, Diemen, Netherlands

[27] Ambulantes Krebs Zentrum, Frankfurt, Germany

[28] IARC, Lyon, France

[29] Med & Healthcare Prod Regulatory Agcy, London, England

[30] Karolinska Inst, Stockholm, Sweden

[31] NICE, London, England

[32] ECPC, Brussels, Belgium

[33] Maastricht Univ, Med Ctr, Maastricht, Netherlands

[34] Roche Innovat Ctr Basel, Basel, Switzerland

[35] Inst Gustav Roussy, Paris, France

来源：

EUROPEAN JOURNAL OF CANCER | 2019年 / 114卷

关键词：

Biomarkers; Evidence-driven optimal health-care delivery; Molecular and immunologic profiling; Health technology assessment; Clinical trials; GUIDELINES; ACCESS;

D O I：

10.1016/j.ejca.2019.03.025

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Academic, industry, regulatory leaders and patient advocates in cancer clinical research met in November 2018 at the Innovation and Biomarkers in Cancer Drug Development meeting in Brussels to address the existing dichotomy between increasing calls for personalised oncology approaches based on individual molecular profiles and the need to make resource and regulatory decisions at the societal level in differing health-care delivery systems around the globe. Novel clinical trial designs, the utility and limitations of real-world evidence (RWE) and emerging technologies for profiling patient tumours and tumour-derived DNA in plasma were discussed. While randomised clinical trials remain the gold standard approach to defining clinical utility of local and systemic therapeutic interventions, the broader adoption of comprehensive tumour profiling and novel trial designs coupled with RWE may allow patient and physician autonomy to be appropriately balanced with broader assessments of safety and overall societal benefit. (C) 2019 Published by Elsevier Ltd.

引用

页码：128 / 136

页数：9

共 22 条

[1] Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach
Aerts, Hugo J. W. L.
Velazquez, Emmanuel Rios
Leijenaar, Ralph T. H.
Parmar, Chintan
Grossmann, Patrick
Cavalho, Sara
Bussink, Johan
Monshouwer, Rene
Haibe-Kains, Benjamin
Rietveld, Derek
Hoebers, Frank
Rietbergen, Michelle M.
Leemans, C. Rene
Dekker, Andre
Quackenbush, John
Gillies, Robert J.
Lambin, Philippe
[J]. NATURE COMMUNICATIONS, 2014, 5
[2] Variation in Health Technology Assessment and Reimbursement Processes in Europe
Akehurst, Ronald L.
Abadie, Eric
Renaudin, Noel
Sarkozy, Francois
[J]. VALUE IN HEALTH, 2017, 20 (01) : 67 - 76
[3] Access to innovative oncology medicines in Europe
Bergmann, L.
Enzmann, H.
Thirstrup, S.
Schweim, J. K.
Widera, I.
Zwierzina, H.
[J]. ANNALS OF ONCOLOGY, 2016, 27 (02) : 353 - 356
[4] Equal access to innovative therapies and precision cancer care
Buzyn, Agnes
Blay, Jean-Yves
Hoog-Labouret, Natalie
Jimenez, Marta
Nowak, Frederique
Le Deley, Marie-Cecile
Perol, David
Cailliot, Christian
Raynaud, Jacques
Vassal, Gilles
[J]. NATURE REVIEWS CLINICAL ONCOLOGY, 2016, 13 (06) : 385 - 393
[5] Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) A Hybridization Capture-Based Next-Generation Sequencing Clinical Assay for Solid Tumor Molecular Oncology
Cheng, Donavan T.
Mitchell, Talia N.
Zehir, Ahmet
Shah, Ronak H.
Benayed, Ryma
Syed, Aijazuddin
Chandramohan, Raghu
Liu, Zhen Yu
Won, Helen H.
Scott, Sasinya N.
Brannon, A. Rose
O'Reilly, Catherine
Sadowska, Justyna
Casanova, Jacklyn
Yannes, Angela
Hechtman, Jaclyn F.
Yao, Jinjuan
Song, Wei
Ross, Dara S.
Oultache, Alifya
Dogan, Snjezana
Borsu, Laetitia
Hameed, Meera
Nafa, Khedoudja
Arcila, Maria E.
Ladanyi, Marc
Berger, Michael F.
[J]. JOURNAL OF MOLECULAR DIAGNOSTICS, 2015, 17 (03) : 251 - 264
[6] Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13
Davis, Courtney
Naci, Huseyin
Gurpinar, Evrim
Poplavska, Elita
Pinto, Ashlyn
Aggarwal, Ajay
[J]. BMJ-BRITISH MEDICAL JOURNAL, 2017, 359
[7] Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL
Deans, Zandra C.
Costa, Jose Luis
Cree, Ian
Dequeker, Els
Edsjo, Anders
Henderson, Shirley
Hummel, Michael
Ligtenberg, Marjolijn J. L.
Loddo, Marco
Machado, Jose Carlos
Marchetti, Antonio
Marquis, Katherine
Mason, Joanne
Normanno, Nicola
Rouleau, Etienne
Schuuring, Ed
Snelson, Keeda-Marie
Thunnissen, Erik
Tops, Bastiaan
Williams, Gareth
van Krieken, Han
Hall, Jacqueline A.
[J]. VIRCHOWS ARCHIV, 2017, 470 (01) : 5 - 20
[8] Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children
Drilon, A.
Laetsch, T. W.
Kummar, S.
DuBois, S. G.
Lassen, U. N.
Demetri, G. D.
Nathenson, M.
Doebele, R. C.
Farago, A. F.
Pappo, A. S.
Turpin, B.
Dowlati, A.
Brose, M. S.
Mascarenhas, L.
Federman, N.
Berlin, J.
El-Deiry, W. S.
Baik, C.
Deeken, J.
Boni, V.
Nagasubramanian, R.
Taylor, M.
Rudzinski, E. R.
Meric-Bernstam, F.
Sohal, D. P. S.
Ma, P. C.
Raez, L. E.
Hechtman, J. F.
Benayed, R.
Ladanyi, M.
Tuch, B. B.
Ebata, K.
Cruickshank, S.
Ku, N. C.
Cox, M. C.
Hawkins, D. S.
Hong, D. S.
Hyman, D. M.
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (08) : 731 - 739
[9] Clinical use of biomarkers in breast cancer: Updated guidelines from the European Group on Tumor Markers (EGTM)
Duffy, M. J.
Harbeck, N.
Nap, M.
Molina, R.
Nicolini, A.
Senkus, E.
Cardoso, F.
[J]. EUROPEAN JOURNAL OF CANCER, 2017, 75 : 284 - 298
[10] Preapproval and postapproval evidence on drugs for multiple sclerosis
Gerardi, Chiara
Bertele', Vittorio
Rossi, Silvia
Garattini, Silvio
Banzi, Rita
[J]. NEUROLOGY, 2018, 90 (21) : 964 - 973

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