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Tarantino et al. Cancer Drug Resist 2019;2:43-52                                  Cancer
               DOI: 10.20517/cdr.2018.22                                             Drug Resistance




               Review                                                                        Open Access


               Opportunities and challenges of implementing
               Pharmacogenomics in cancer drug development


               Paolo Tarantino , Dario Trapani , Stefania Morganti , Emanuela Ferraro , Giulia Viale , Paolo
                                                                                             1,2
                                                                                1,2
                             1,2
                                            1,2
                                                              1,2
               D’Amico , Bruno Achutti Duso , Giuseppe Curigliano 1,2
                       1,2
                                           1,2
               1 Division of Early Drug Development for Innovative Therapies, IEO, European Institute of Oncology IRCCS, Milan 20141, Italy.
               2 Department of Oncology and Haematology (DIPO), University of Milan, Milan 20122, Italy.
               Correspondence to: Prof. Giuseppe Curigliano, Division of Early Drug Development for Innovative Therapies, IEO, European
               Institute of Oncology IRCCS, Via Ripamonti 435, Milan 20141, Italy. E-mail: giuseppe.curigliano@ieo.it
               How to cite this article: Tarantino P, Trapani D, Morganti S, Ferraro E, Viale G, D’Amico P, Duso BA, Curigliano G. Opportunities
               and challenges of implementing Pharmacogenomics in cancer drug development. Cancer Drug Resist 2019;2:43-52. http://
               dx.doi.org/10.20517/cdr.2018.22

               Received: 31 Oct 2018    First Decision: 12 Nov 2018    Revised: 1 Feb 2019    Accepted: 15 Feb 2019    Published: 19 Mar 2019

               Science Editor: Enrico Mini     Copy Editor: Cai-Hong Wang    Production Editor: Huan-Liang Wu



               Abstract
               Cancer drug development is a time and resources consuming process. Around 90% of drugs entering clinical trials
               fail due to lack of efficacy and/or safety issues, more often after conspicuous research and economic efforts. Part
               of the discarded drugs might be beneficial only in a subgroup of the study patients, and some adverse events might
               be prevented by identifying those patients more vulnerable to toxicities. The implementation of pharmacogenomic
               biomarkers allows the categorization of patients, to predict efficacy and toxicity and to optimize the drug development
               process. Around seventy FDA approved drugs currently present one or more genetic biomarker to keep in consideration,
               and with the progress of Precision Medicine tailoring therapies on individuals’ genomic landscape promises to become a
               new standard of cancer care. In the current article we review the role of pharmacogenomics in cancer drug development,
               underlying the advantages and challenges of their implementation.


               Keywords: Pharmacogenomics, cancer drug development, precision medicine, clinical trials




               INTRODUCTION
               Since the development and approval of the first targeted agents, oncology care has moved from a one-
               size-fits-all paradigm with pure histology-oriented approach toward a tailored treatment, selected upon


                           © The Author(s) 2019. Open Access This article is licensed under a Creative Commons Attribution 4.0
                           International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use,
                sharing, adaptation, distribution and reproduction in any medium or format, for any purpose, even commercially, as long
                as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license,
                and indicate if changes were made.


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