Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Able and willing to provide informed consent
Male or female, aged 18 years or older at the time of study initiation
Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated
Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures
Life expectancy of at least 6 months

Exclusion Criteria

Prior treatment with irinotecan
DPYD or UGT1A1 genotype already known
Severe renal or hepatic impairment (or unacceptable laboratory values), including:
- Neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L
- Hepatic function as defined by serum bilirubin >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >2.5 x ULN, or in case of liver metastases ALT and AST>5 x ULN
- Renal function as defined by serum creatinine >1.5 x ULN, or creatinine clearance <60 ml/min (by Cockcroft-Gault Equation)
Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study
Treating physician does not want subject to participate

Primary Outcome Measures

Name	Time	Method
Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose	14 days	The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
Fidelity: Level of Agreement With Dose Recommendations	14 days	The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers	14 days	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

Secondary Outcome Measures

Name	Time	Method
Severe Treatment Related Adverse Events (TRAE)	6 months	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.

Locations (3): Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States