Research forum
Interview with Daniel B. Brown, MD, FSIR
Daniel B. Brown, MD, FSIR, is principal investigator of the Radiation-emitting SIR-Spheres in Nonresectable (RESIN) Liver Tumor Patient Registry. Vanderbilt University Medical Center, where Dr. Brown is director of interventional oncology, is the coordinating center, overseeing the 40 sites that are currently participating in the registry.
Earlier this year, Sirtex renewed a research grant for the registry work, providing $2.6 million over three years—combining with the company’s original 2015 grant for a total of more than $3 million.
We recently sat down with Dr. Brown to discuss the registry, the grant and the potential impact they’ll have on Y-90 treatment of liver cancer.
Tell us a little about your work at Vanderbilt. With Vanderbilt’s RESIN Study, we’re developing a large data set of real- world evidence as we treat and follow our patients. Unlike common disease states, where we can get groups of more than 100 patients relatively easily, individual institutions may only see one or two such cases each year. But if we can combine into one registry the two patients I see, the two patients someone else sees, and all the other small groups of patients seen at other institutions, then together we can build a sizable data set that can help IRs get more traction in treating those patients. For a number of tumors without data regarding liver-directed therapy, IRs have a hard time getting approval for the use of Y-90; insurance carriers won’t cover it in those cases because of the lack of available data.
We’ll collect all the data into a database Vanderbilt developed called Research Electronic Data Capture (REDCap). Our
20 IRQ | SUMMER 2018
data management team is one of the best in the country, so we can do a great job of extracting valuable information from the data we collect.
That said, this is not better than prospective randomized studies like the ATTRACT Trial—those studies are the gold standard. But where that prospective data is difficult to come by, I see this kind of registry as a promising way to compile large sets of data.
How does the renewed grant impact your work? In 2015, they funded our registry as a start-up, when we basically operated as a small research enterprise. We started with just a few sites but grew a lot faster than either Sirtex or we envisioned it would. Sites were eager to get started as soon as we launched and, as word spread, more and more sites across the country enrolled in the registry. We’re now up to 1,000 patients. At the end of the day, this is going to be one of the largest studies in IO that’s ever been done.
With the grant renewal, we can now add needed staff so we can catch up on a number of things including invoicing—which isn’t the exciting part but remains very necessary. The renewal also allows us to better monitor and track the sites. It allows us to do the data cleaning, which will eventually allow us to start publishing our findings. Overall, the renewal will lead to more satisfaction for the sites.
But perhaps the biggest impact of the contract renewal is the statement that Sirtex has made regarding their commitment—it demonstrates the value they see in our work. I truly appreciate the vision Sirtex has had in working with me throughout this effort.
You’ve cited a goal of 3,000 patients. What happens when you reach that goal? We’ll be able to look at how patients responded to different lines of therapy. In the database we have a number of different biomarkers, serum blood tests. We can look at whether people with certain mutations responded better to treatment; how patients responded who were also receiving chemotherapy; how Y-90 performed in patients with different immunological agents vs. other groups.
We’ll be able to get some signal-to noise data for prospective randomized trails down the line that can further validate conclusions from the registry data. That’s huge because I believe that the best use of Y-90 for things like colorectal cancer, breast cancer, etc. is going to be integrating it into existing paradigms—or finding paradigms that Y-90 works with. Cancer is a systemic disease process, so treating the liver’s important but the best outcomes are when we combine the Y-90 treatment with some kind of systemic or biologic treatment.
And hopefully from this data we’ll be able to get signal to noise for very common cancers like breast or colon cancer where we can combine those treatments and really personalize care for patients.
Have you found anything particularly surprising in the data? We haven’t dug in too deep yet. Part of this was intentional to allow time for data to mature. Additionally, we were spread thin trying to initiate and monitor the sites, so we never had time to dig into the data. Now with the contract renewal, we can expand our staff. It’s kind of synergistic that the contract is renewed just as we’re reaching 1,000 patients; there should be a lot of good data to dig into now.
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