Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects from chemotherapy agents. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing cancer care providers with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide treatment decisions and improve patient outcomes. This is a non-randomized implementation study, which means that all participants in this study will undergo genotyping for a pharmacogenetic test. The investigators will primarily measure the feasibility of using this test to guide cancer care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
552
Patients with reduced function alleles (DPYD intermediate or poor metabolizer and/or UGT1A1 poor metabolizer) will be recommended to receive dose reductions per clinical pharmacogenetic guidelines. Patients that do not carry actionable alleles (DPYD normal metabolizer and/or UGT1A1 normal or intermediate metabolizer) will receive standard dosing.
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose
The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
Time frame: 14 days
Fidelity: Level of Agreement With Dose Recommendations
The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
Time frame: 14 days
Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers
The number and percentage of participants with pharmacogenetic tests ordered compared to the number of patients eligible for testing at participating sites during the study timeframe
Time frame: 14 days
Severe Treatment Related Adverse Events (TRAE)
Percentage of patients experiencing a severe TRAE (an event requiring hospitalization, emergency room visits, or oncology evaluation center). Severe TRAEs were one of the outcomes measured by the study.
Time frame: 6 months
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