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

Roberto Salgado; David B Solit; David L Rimm; Jan Bogaerts; Renzo Canetta; Tracy Lively; Kim Lyerly; Paul N Span; Alison Bateman-House; Amr Makady; L Bergmann; Sumimasa Nagai; Chris Smith; Mark Robson; Mary Savage; Emile Voest; Christopher Sweeney; Philippe Lambin; Marlene Thomas; Lyndsay Harris; Denis Lacombe; Chistophe Massard; IBCD-Faculty

doi:10.1016/j.ejca.2019.03.025

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

Eur J Cancer. 2019 Jun:114:128-136. doi: 10.1016/j.ejca.2019.03.025. Epub 2019 May 3.

Authors

Roberto Salgado¹, David B Solit², David L Rimm³, Jan Bogaerts⁴, Renzo Canetta⁵, Tracy Lively⁶, Kim Lyerly⁷, Paul N Span⁸, Alison Bateman-House⁹, Amr Makady¹⁰, L Bergmann¹¹, Sumimasa Nagai¹², Chris Smith¹³, Mark Robson², Mary Savage¹⁴, Emile Voest¹⁵, Christopher Sweeney¹⁶, Philippe Lambin¹⁷, Marlene Thomas¹⁸, Lyndsay Harris⁶, Denis Lacombe⁴, Chistophe Massard¹⁹; IBCD-Faculty

Collaborators

IBCD-Faculty:
Rene Bernards²⁰, Jan Bogaerts²¹, Renzo Canetta²², Richard Sullivan²³, Sabine Tejpar²⁴, Nina Lukinova²⁵, Herbert K Lyerly²⁶, Helen Moore²⁷, Malcolm A Smith²⁷, Laura Yee²⁷, Ray DuBois²⁸, William C Hahn²⁹, Pasi Janne²⁹, David B Solit², Cheryl L Willman³⁰, David Rimm³¹, Alison Bateman-House⁹, Amr Makady³², Lothar Bergmann³³, Sumimasa Nagai¹², Marlene Thomas¹⁸, Ian A Cree³⁴, Priti Hegde³⁵, Shirley Hopper³⁶, Chris Smith¹³, Marc Robson², Mary Savage¹⁴, Emile Voest²⁰, Christopher Sweeney¹⁶, Magnus Ingelman-Sundberg³⁷, Gwen Nichols³⁸, Francois Maignen³⁹, Benjamin Besse¹⁹, Rafal Swierzewski⁴⁰, Philippe Lambin⁴¹, Astrid Kiermaier⁴², Denis Lacombe²¹, Tracy Lively²⁷, Christophe Massard¹⁹, Michael Caliguri⁴³, Victor Velculescu⁴⁴, Paolo Foggi⁴⁵, Willem C Hahn⁴⁶, Nina Lukinova²⁷, Roberto Salgado⁴⁷, Vassilis Golfinopoulos²¹

Affiliations

¹ Department of Pathology GZA-ZNA, Antwerp, Belgium; Division of Research, Peter Mac Callum Cancer Center, Melbourne, Australia. Electronic address: roberto@salgado.be.
² Memorial Sloan Kettering Cancer Center, New York, NY, USA.
³ Dept. of Pathology, Yale University School of Medicine, New Haven, CT, USA; Dept. of Medicine, Yale University School of Medicine, New Haven, CT, USA.
⁴ EORTC Headquarters, Brussels, Belgium.
⁵ Independent Consultant, Madison, CT, USA.
⁶ National Cancer Institute, Bethesda, MD, USA.
⁷ Duke University, Durham, NC, USA.
⁸ Radiotherapy and OncoImmunology Laboratory, Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
⁹ Division of Medical Ethics, NYU Langone Health, New York, NY, USA.
¹⁰ The National Healthcare Institute (ZIN), Diemen, the Netherlands.
¹¹ Medical Clinic II, University Hospital Frankfurt, Germany; Ambulantes Krebszentrum Frankfurt, Germany.
¹² Translational Research Center, The University of Tokyo Hospital and PMDA, Tokyo, Japan.
¹³ CRUK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom.
¹⁴ Merck, Whitehouse Station, NJ, USA.
¹⁵ The Netherlands Cancer Institute, Amsterdam, the Netherlands.
¹⁶ Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
¹⁷ The D-Lab & The M-Lab, Department of Precision Medicine, GROW Research Institute for Oncology, Maastricht, The Netherlands.
¹⁸ Roche, Basel, Switzerland.
¹⁹ Institut Gustave Roussy, Paris, France.
²⁰ Netherlands Cancer Institute, Amsterdam, the Netherlands.
²¹ EORTC, Brussels, Belgium.
²² Independent Consultant, USA.
²³ King's College London, London, UK.
²⁴ U.Z. Leuven, Leuven, Belgium.
²⁵ NCI, Rockville, MD, USA.
²⁶ Duke University Medical Center, Durham, NC, USA.
²⁷ National Cancer Institute (NCI), Bethesda, MD, USA.
²⁸ Medical University of South Carolina, Charleston, SC, USA.
²⁹ Dana-Farber Cancer Institute, Boston, MA, USA.
³⁰ University of New Mexico, Albuquerque, NM, USA.
³¹ Dept. of Pathology, Yale University School of Medicine, New Haven, CT, USA.
³² Interne Geneeskunde Sector Zorg Zorginstituut Nederland, Diemen, the Netherlands.
³³ Ambulantes Krebszentrum, Frankfurt, Germany.
³⁴ IARC, Lyon, France.
³⁵ Genentech, South San Francisco, CA, USA.
³⁶ Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
³⁷ Karolinska Institut, Sweden.
³⁸ The Leukemia & Lymphoma Society, New York, NY, USA.
³⁹ NICE, London, United Kingdom.
⁴⁰ ECPC, Belgium.
⁴¹ Maastricht University Medical Centre, Maastricht, the Netherlands.
⁴² Roche Innovation Center Basel, Basel, Switzerland.
⁴³ City of Hope National Medical Center, Duarte, CA, USA.
⁴⁴ Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
⁴⁵ AACR, USA.
⁴⁶ Dana Farber Cancer Institute, Boston, MA, USA.
⁴⁷ Antwerp, Belgium; Melbourne, Australia.

PMID: 31060925
DOI: 10.1016/j.ejca.2019.03.025

Abstract

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.

Keywords: Biomarkers; Clinical trials; Evidence-driven optimal health-care delivery; Health technology assessment; Molecular and immunologic profiling.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Humans
Medical Oncology / methods*
Precision Medicine*