%0 Journal Article
%T Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices
%A Edward S. Kim
%A Jennifer L. Ersek
%A Lora J. Black
%A Michael A. Thompson
%J About the Ed Book | ASCO Educational Book
%D 2018
%R https://doi.org/10.1200/EDBK_200633
%X Precision medicine has been discussed for decades, especially in the field of oncology. Precision medicine is an approach to disease prevention and treatment that accounts for variability in the genes, environment, and lifestyle of each person.1 Precision medicine approaches to identifying variability in genetics include the use of multiple testing techniques, including immunohistochemistry, fluorescence in situ hybridization, chromogenic in situ hybridization, flow cytometry, and next-generation sequencing. These techniques are used either in combination or individually to identify molecular abnormalities in a patient's DNA with the hopes of identifying therapeutic targets. Historically, patients with cancer have been treated with cytotoxic chemotherapy, which has cured some cancers (e.g., testicular cancer) but also created debates on the overall benefit versus risk. Studies would test single agents, doublets, triplets, and even quadruplets with increasing toxicity and limitations in efficacy. Categorizing patients consisted of organ site of origin and histologic classification. With the increasing development of molecularly targeted therapies, technological advances in genomic testing, and refined techniques for obtaining specimens amenable to genomic testing, precision medicine has become a reality in clinical practice. Molecular assessments now drive therapeutic determinations, which has subsequently decreased the use of chemotherapy and blurred the lines of phenotypic classification (histopathology) with genotypic characterization (genetic testing). For instance, in patients with metastatic, non¨Csmall cell lung cancer, approximately 50% of patients' tumors harbor a molecular abnormality (e.g., EGFR, ALK, ROS1, BRAF, PD-L1) that could be treated with a targeted therapy. For some cancers, it is now expected that the clinical practice of oncology must integrate precision medicine. Alongside these technology advances, a plethora of trials have been initiated to elucidate molecular pathways that may be involved with cancer development and progression. Examples of precision medicine trials include the BATTLE,2 the National Cancer Institute (NCI) MATCH and M-PACT,3 the ASCO TAPUR4 trials, and several other studies.5 Precision medicine trials invoke new and different challenges in their design and execution, thus requiring new strategies for successful implementation in both the academic and community-based settings. To have successful precision medicine trials in the community setting, practices first must be committed to developing a multidisciplinary
%U http://ascopubs.org/doi/full/10.1200/EDBK_200633