Advocate Aurora Health cancer clinics across Wisconsin are the first in the state to join American Society of Clinical Oncology® Targeted Agent and Profiling Utilization Registry (TAPUR™) Study, which aims to provide patients who have exhausted standard treatment options with access to targeted study drugs matched to the genomic profiles of their cancers.
“Deciding what treatments to use against a specific patient’s cancer is challenging,” said hematologist and oncologist Antony Ruggeri, MD, Advocate Aurora Research Institute principal investigator for the study. “By analyzing an individual patient’s DNA, clinicians can select certain anticancer drugs that target the unique genetic mutation in the patient’s cells that allows the tumor to grow uncontrollably. This is called targeted therapy.”
The purpose of the study is to evaluate the safety and efficacy of many commercially available, targeted anticancer drugs in treating participants with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma that have a genomic variant known or predicted to be sensitive to one of the study drugs. Researchers will enroll study participants who have cancer that did not respond or stopped responding to at least one previous cancer treatment, or those who have cancer that has no standard treatment.
Participants in the study will have already had a laboratory test ordered by their personal doctor that examined the DNA of some of their cancer cells. Based on the results of that test, the study doctor and the research team will determine which one of the drugs in the study might target their individual cancer.
“The drugs available through the study are all approved by the U.S. Food and Drug Administration (FDA) for the treatment of some type of cancer – but haven’t been FDA-approved to treat each participant’s unique cancer,” Dr. Ruggeri said. “For this reason, the drugs are considered investigational treatments.”
While clinicians can prescribe drugs outside of a clinical trial for uses not specified on the drug label, such off-label uses may not be a covered treatment under a patient’s insurance, which leaves the patient financially vulnerable. Additionally, when off-label drugs are prescribed for targeted therapies outside of a clinical trial, their safety and efficacy is not typically recorded or analyzed, so no data is collected that could potentially guide treatments for future patients. Finally, many oncologists do not have the expertise or access to experts in cancer genomics.
The study drug selected for each participant in the clinical trial will be chosen by their treating physician, who will have access to a Molecular Tumor Board, a panel of experts in cancer and cancer genomics who can assist in identifying which drug might be an appropriate option for each participant.
“While the idea is not new, personalized medicine has recently taken a monumental leap forward, as our understanding of cancer genomics has increased and genomic technologies have become more available and affordable,” said Nina Garlie, PhD, vice president of clinical trials research at the Research Institute. “Advocate Aurora Research Institute is proud to support clinical trials such as this one that may help validate or build on the existing evidence that genomic testing can guide clinicians to new drug treatments for patients with advanced cancer.”
Because the study includes broader eligibility criteria and allows the treating physician greater discretion, it will include a broader patient population than many clinical trials.
Researchers at sites across the country will enroll more than 3,300 participants in the TAPUR Study, which evaluates the use FDA-approved drugs that target a specific genomic variant in a tumor gene in people with advanced stage cancer.
The study is available through Advocate Aurora’s National Cancer Institute Community Oncology Research Program (NCORP) at all 17 of its Wisconsin community cancer clinics.
ASCO, American Society of Clinical Oncology, and TAPUR are trademarks of the American Society of Clinical Oncology, Inc., used with permission.
To learn more about Advocate Aurora’s research, visit aah.org/research.