Center for Personalized Therapeutics

PhOCus Trial

Many cancer patients who receive chemotherapy experience adverse drug events and treatment related toxicities. Pharmacogenomics is the study of how germline genetic variants affect individual response to medications, and has promise to personalize chemotherapy drug dosing to maximize efficacy and safety in oncology patients. Chemotherapies such as fluoropyrimidines and irinotecan have well-known pharmacogenomic associations, and preemptive pharmacogenomic testing prior to treatment offers the potential to identify patients at increased risk for toxicities. The implementation of Pharmacogenomic Testing in Oncology Care is a project whose goal is to provide personalized chemotherapy dosing in oncology patients, which we hypothesize will result in improved treatment tolerability as well as outcomes for cancer patients.

The PhOCus project is led by principal investigator Dr. Peter H O’Donnell and hematology/oncology as well as clinical pharmacology fellow Dr. Natalie Reizine.

Adult oncology patients receiving care at the University of Chicago Medical Center, and for whom treatment with fluoropyrimidine and/or irinotecan therapy is being considered are eligible.  Patients will be randomized to pharmacogenomic and control arms. In the pharmacogenomic arm, providers will be given immediate access to patient-specific information and genotypic dosing guidance in the form of the electronic medical record (EMR) integrated software tool, the Genomic Prescribing System (GPS), which provides point of care pharmacogenomic information, dosing recommendations, and literature references to help guide personalized prescribing. In the control arm, initial fluoropyrimidine and irinotecan dosing will occur per standard of care, and patient genotyping will occur 6 months after enrollment, or at the time of a chemotherapy related adverse event. The two primary endpoints are 1) the dose intensity deviation rate (the proportion of patients receiving chemotherapy dosing modifications) during the 1st treatment cycle, and 2) the incidence of severe medication related toxicities throughout the entire treatment course. Secondary endpoints will include chemotherapy dose intensity and progression free survival. Exploratory endpoints will include the impact on prescribing of additional oncology related and supportive care medications, as well as patient-reported quality of life and patient understanding of pharmacogenomics.