Many of today’s new drug approvals and standard-of-care treatments have a companion diagnostic test that identifies biomarkers in a patient’s tumor tissue or blood to determine whether they are an appropriate candidate for the therapy. When those results show that they’re not a good match for the U.S. Food and Drug Administration (FDA)-approved treatment, the findings may identify a biomarker-directed clinical trial as an alternative option. Here’s how oncology nurses can help patients understand which clinical trials listed on their test results might be an option for them.
The Basics of Biomarkers and Test Results
Testing can identify inherited DNA changes (germline) that increase a person’s cancer risk, but it can also uncover acquired changes in a tumor (somatic) and help suggest therapies that could target the driver variant that is leading to cancer growth. Biomarker test results contain the following details that you can help your patients understand:
- Predictive biomarkers that have an FDA-approved targeted drug, predictive biomarkers that don’t have approved targeted therapy for that patient’s disease but do have targeted drugs approved for another disease, or biomarkers that have no targeted drug or clinical trial options
- Disease-relevant genes with no reportable alterations, meaning the test didn’t identify alterations in genes that are commonly found in that tumor type
- Information about each biomarker as it relates to that cancer type (e.g., evidence about potential treatment strategies, frequency, prognosis)
- Variants of unknown significance that are considered neither benign or pathogenic and are not actionable
- All clinical trials a patient might be eligible for, sorted by biomarker
Keep in mind that clinical trials identified on a biomarker test result are the ones listed on the ClinicalTrials.gov website at the time of test result and might not still be enrolling patients later. If your setting doesn’t have a clinical trial team, visit ClinicalTrials.gov to confirm whether a trial is currently still enrolling. You may also call the site investigator to be certain that trial is still open.
Additionally, many biomarker-driven clinical trials are designed differently than traditional trials. Basket trials study patients with different cancer diagnoses but the same biomarker who receive one targeted drug, whereas umbrella trials offer multiple targeted drug options for a single type of cancer. By design, both types of trials are available across multiple institutions in a variety of geographic locations, increasing available options for some patients.
Your role as an oncology nurse often requires you to be a patient advocate for biomarker-driven clinical trials. Helping patients to understand their biomarker test results can empower them to feel certain that they have explored every treatment possibility available.