Dan Brown, M.D., professor of Radiology and Radiological Sciences and chief of Interventional Oncology, will spearhead a national Vanderbilt-led research registry that tracks cancer patients whose tumors are treated with Yttrium-90 (Y-90), a radioactive isotope.
The Radiation-Emitting SIR-Spheres in Non-Resectable (RESIN) Liver Tumor Patient Registry is the result of a collaboration between VUMC, initially up to six other medical centers and Sirtex Medical Inc., the firm that manufactures Y-90 resin microspheres that are approved for use in Selective Internal Radiation Therapy (SIRT) for the treatment of metastatic colorectal liver tumors.
Sirtex, based in Sydney, Australia, with offices in Woburn, Massachusetts, is a global life-sciences firm that designed the SIR-Spheres Resin Microspheres. These microspheres lodge in the microvasculature surrounding a tumor and 94 percent of the radiation inside the spheres is delivered to the tumor within 11 days.
Interventional oncology is a rapidly advancing field that uses image-guided technology to directly target solid tumors.
“For some tumor types, there is a great deal of acceptance of treatment through the artery, while with others there is a need for larger data sets to prove value,” said Brown.
To deliver the Y-90, Vanderbilt experts like Brown, Andrew Lipnik, M.D., assistant professor of Radiology and Radiological Sciences, and incoming Interventional Radiology section chief Filip Banovac, M.D., insert a catheter into an artery in the groin and thread the catheter to tumors in the liver.
These are tumors that either don’t respond well to systemic chemotherapy or have progressed during treatment. Delivery via a catheter allows medications like Y-90 to be infused directly to the tumor, thus sparing the surrounding healthy tissue.
Sirtex Y-90 microspheres are FDA-approved for use in liver metastases from colorectal cancer. The product is often used for other hard-to-treat cancers but little data is available. Some researchers have reported on therapeutic uses of Y-90 for various types of tumors, but the number of patients treated is so small that the studies are not statistically significant. So Brown and colleagues, in collaboration with Sirtex, initiated the registry to collect data in a coordinated fashion and determine if specific therapeutic protocols are actually benefiting patients.
“The registry includes tumor type, prescribed activity of radiation, any chemotherapy drugs given and it also includes a number of cell receptors that are treated with targeted therapies,” Brown said.
Sirtex will support Vanderbilt’s work as the coordinating center for the registry, including statistical analysis of data that will be provided by Yu Shyr, Ph.D., Harold L. Moses Professor of Cancer Research and director of Vanderbilt’s Center for Quantitative Sciences. Shyr and his colleagues will work to ensure the integrity of the statistical analyses.
Eric First, M.D., chief medical officer at Sirtex said, “We are very pleased to have a widely-recognized interventional oncology and Y-90 expert like Dr. Brown and Vanderbilt lead this very important initiative and look forward to generating clinical data that may impact future patient treatment options.”
Brown will add additional medical centers to the registry to help accelerate data collection and answer important questions about the effectiveness of Y-90 therapy for specific tumor types and whether it can be used successfully in combination with other forms of systemic therapy.
“I think this is a great way to gather outcomes information and determine where there is value to the patient.”
