A BCRF investigator for over two decades, Daniel Hayes, MD, has led an illustrious career in breast cancer research. He is nationally and internationally recognized for his contributions in the field of experimental therapeutics targeted to breast cancer, and his work on serum and tissue markers such as HER-2, circulating tumor cells and pharmacogenomics which have prognostic and/or predictive value in the treatment of breast cancer. Today he serves as the Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center (UMCCC) and the Stuart B. Padnos Professor of Breast Cancer Research. He is immediate past-president of the American Society of Clinical Oncology.
BCRF had an opportunity to talk to Dr. Hayes as he closed out his term as ASCO President where we discussed the latest advancements in precision medicine, disparities in breast cancer care and strategies on reducing the global cancer burden.
Below is our discussion on two exciting advancements in precision medicine. You can read Dr. Hayes’ full presidential address delivered at the annual meeting of ASCO in June 2017 here.
BCRF: In your presidential address at the ASCO meeting you talked about some of the initiatives ASCO is leading in precision medicine. Can you tell us a little more about the TAPUR trial and CancerLinQ?
Dr. Hayes: TAPUR (Targeted Agent and Profiling Utilization Registry) is a very pragmatic clinical study in which drugs that are approved in one indication might be used in another indication based on molecular profiling of a patient tumor. In other words, using a drug “off label”, but in the context of a clinical trial, which allows us to monitor response and toxicities that could differ in one group of patients compared to another.
TAPUR is unprecedented in the recent history of clinical cancer research. In the long run, it will be a win/win/win. It’s a win for the pharmaceutical companies that make the drugs but aren’t interested in doing the off-label studies. It’s a win for society in terms of not paying for drugs if they don’t work, but on the other hand, if they do work, providing treatment alternatives. Most importantly, it’s a win for our patients who get an opportunity to have access to drugs that they wouldn’t otherwise. That’s pretty exciting.
There are currently over 500 patients on treatments within TAPUR and many more who have been screened.
BCRF: Can you tell us a little more about CancerLinQ?
Dr. Hayes: CancerLinQ is a database linked to the electronic health record. Once a physician or practice signs on to CancerLinQ the daily clinical notations are added to the database. Its primary function is to be used as a quality control measure for individual practices or doctors, but we hope it will become one of the world’s largest and most granular outcomes databases for observational research.
As an example, clinical trials are our primary mechanism for advancing clinical management of cancer, but we can’t always extrapolate clinical trial data to the average patient. CancerLinQ is going to make that possible.
Perhaps even more importantly, CancerLinQ will be collecting real world evidence for toxicity. Toxicity refers to unwanted side effects of the drug. These can mild and acute, such as low grade or treatable diarrhea; or severe, such as depletion of white blood cells, and may be chronic, such as peripheral neuropathy that can last long after treatment ends and affect long-term quality of life. Once a drug gets out into the market, into the community, little if any, toxicity data are generated. CancerLinQ will allow us to document what we see in the clinic, which could be very different than what we saw in the clinical trials, just because the patients are different. That’s pretty exciting and I think it’s the future of precision medicine. We now have well over one million individual patient records in CancerLinQ and expect to be able to make these data available for observational research very soon.
This kind of innovation spurs competition and that’s good, because it lights a fire under what we do and ultimately leads to collaboration and we’re already beginning to see some of that.
Continue reading about Dr. Hayes’ and ASCO’s vision for tackling health disparities and advancing value based care in Part 2 of our interview.
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