%0 Journal Article
%T Complexity of Delivering Precision Medicine: Opportunities and Challenges
%A Amy E. McKee
%A Andrew A. Davis
%A Victoria M. Villaflor
%A Warren A. Kibbe
%J About the Ed Book | ASCO Educational Book
%D 2018
%R https://doi.org/10.1200/EDBK_200279
%X Precision medicine in oncology aims to match individual patients with the right treatment at the right time based on the patient¡¯s biologic and molecular characteristics. Early successes with molecularly targeted agents included the approval of the tyrosine kinase inhibitor imatinib (Gleevec; Novartis), directed at BCR-ABL in chronic myeloid leukemia, and trastuzumab, a monoclonal antibody that targets HER2 amplification in breast cancer.1,2 These agents demonstrated great promise in transforming disease outcomes and improving patient survival. Currently, precision medicine approaches are being applied with molecularly targeted and immune-based therapeutics across multiple histologies, most notably advanced melanoma and non¨Csmall cell lung cancer (NSCLC), among many others. Now, with the advancement and availability of genomic, transcriptomic, proteomic, and metabolomic data, the field is approaching a tipping point. These tools have opened a window through which we can view the incredible complexity and dynamic nature of an individual tumor and begin to assess tumor heterogeneity and predict treatment resistance. When assessing ¡°-omics¡± data from single patients, there are many challenges that complicate therapeutic decision-making. These include relatively simple challenges, such as distinguishing driver and passenger mutations in a given patient, to complex problems, such as accurately assessing and predicting the safety and efficacy of combination therapies based on clinical, pathology, and molecular profiles. Furthermore, across larger cohorts, novel strategies for biomarker-driven therapies, clinical trial design, and meaningful data sharing are necessary to move the field forward. In this article, we review opportunities and challenges in delivering precision medicine to individual patients and explore effective tools under development that will inevitably change the way oncology is practiced. TARGETED THERAPY Section: ChooseTop of pageAbstractTARGETED THERAPY <<BIOMARKERS TO PREDICT RES...NEXT-GENERATION SEQUENCIN...ROLE OF DATA SCIENCE IN P...REGULATORY SCIENCE: THE R...CHALLENGES IN PRECISION M...NEXT STEPSReferences Through the years, there have been a number of success stories demonstrating the promise of targeted therapy in precision oncology. In several instances, particular drug regimens have demonstrated promise based on molecular targets across multiple tumor histologies. For example, the tyrosine kinase inhibitor imatinib has demonstrated efficacy in both chronic myeloid leukemia with BCR-ABL fusion gene and tumors expressing c-kit in
%U http://ascopubs.org/doi/full/10.1200/EDBK_200279