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Implementation of a Precision Oncology Program as an Exemplar of a Learning Health Care System in the VA

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More than a decade ago, the decision was made to dis-integrate the Office of Information Technology from VHA. This was executed with no provision to support the small army of VA clinician-informaticists who had done much in support of patient care, including the creation of the initial iteration of the VA EHR. Although the VA includes small pockets of this clinical informatics culture throughout its organization, the community has been largely silenced and taken refuge at academic affiliates. Access to VA information systems and funding opportunities for development and implementation of tools essential for learning will draw this intellectual capital back to the VA and allow for the VA to lead in this critical arena.

The VA Precision Oncology Program

Precision medicine is a medical model that incorporates the results of genetic diagnostic testing to customize or tailor medical decision making and treatment for the individual patient. Characteristics of the VA health care system that create a favored environment for introducing precision medicine include the single-payer model, where implementation decision and authority are centralized, a standardized EHR that enables informatics requirements, and a clinician and patient culture that supports innovation. To date, the benefits of precision medicine are most robust in cancer care. Under the leadership of Michael Mayo-Smith, MD, the VA New England Healthcare System has completed a regional pilot project in precision oncology that demonstrated feasibility of incorporating a precision medicine program in the clinical care environment.

For the majority of patients with lung cancer, DNA sequencing of tumor tissue identifies driver mutations—alterations believed responsible for tumor growth and behavior. The abundance of both driver and passenger mutations (those alterations whose significance is unknown) identified within an individual cancer specimen and the diversity of alterations found across the spectrum of all patients with cancer virtually assures the unique genetic profile (hence behavior) of any given patient’s tumor. The new generation of antineoplastic agents are targeted therapies that disrupt the downstream effects of these alterations and result in improved anticancer effects and reduced toxicity compared with conventional chemotherapy. The POP approach to cancer treatment determines the mutation profile of malignancies and identifies targeted therapies with the highest likelihood of treatment success. Although many driver mutation-targeted therapy combinations have been FDA approved, many more are in development and are available only as investigational agents.

Work Accomplished

Developed over the past 2 years in VISN 1, POP is a demonstration project that standardizes the processes necessary to deliver precision oncology care for veterans with lung cancer. With approval of the cancer care specialist, targeted sequencing of cancer genes (multiple biomarker panels) is performed on formalinfixed, paraffin-embedded tissue from newly diagnosed lung cancers as part of routine POP cancer care. Samples are shipped within 48 hours of diagnosis to Personal Genome Diagnostics (CancerSelect-88 targeted genome panel: PGD, Baltimore, MD) or Personalis (ACE Extended Cancer Panel: Menlo Park, CA). Following the sequencing of the targeted gene regions for mutations, a formal report of identified genomic aberrations is collated, annotated, and transmitted for inclusion in patient medical records. Both PGD and Personalis use N-of-One (Lexington, MA) to curate the medical literature and provide mutation annotations. The VA Computerized Patient Record System shares mutation results with the treating clinician, and a consultation service, offered through Specialty Care Access Network-Extension for Community technology, is available to help clinicians incorporate the test results into a treatment plan for the patient.

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