Emerging roles for clinical pharmacometrics in cancer precision medicine.

Abstract

Although significant progress has been made in cancer research, there exist unmet needs in patient care as reflected by the 'Cancer Moonshot' goals. This review appreciates the potential utility of quantitative pharmacology in cancer precision medicine. Precision oncology has received federal funding largely due to 'The Precision Medicine Initiative'. Precision medicine takes into account the inter-individual variability, and allows for tailoring the right medication or the right dose of drug to the best subpopulation of patients who will likely respond to the intervention, thus enhancing therapeutic success and reducing "financial toxicity" to patients, families and caregivers. The National Cancer Institute (NCI) committed US$ 70 million from its fiscal year 2016 budget to advance precision oncology research. Through the 'Critical Path Initiative', pharmacometrics has gained an important role in drug development; however, it is yet to find widespread clinical applicability. Stakeholders including clinicians and pharmacometricians need to work in concert to ensure that benefits of model-based approaches are harnessed to personalize cancer care to the individual needs of the patient via better dosing strategies, companion diagnostics, and predictive biomarkers. In medical oncology, where immediate patient care is the clinician's primary concern, pharmacometric approaches can be tailored to build models that rely on patient data already digitally available in the Electronic Health Record (EHR) to facilitate quick collaboration and avoid additional funding needs. Taken together, we offer a roadmap for the future of precision oncology which is fraught with both challenges and opportunities for pharmacometricians and clinicians alike.