The University of Maryland Greenebaum Cancer Center in Baltimore is the first in the nation to successfully perform a new treatment for inoperable liver cancer known as TheraSphere, a non-surgical outpatient therapy that uses microscopic glass beads to deliver radiation directly to tumors.
“Now that the FDA has approved TheraSphere, we have a potentially safer and more effective treatment to offer patients with primary liver cancer,” says David Van Echo, M.D., an oncologist who directs the new drug development program at the University of Maryland Greenebaum Cancer Center. “This is significant, given both the side effects and extended hospital stays required by chemotherapy,” adds Dr. Van Echo, who is also a professor of medicine and oncology and radiation oncology at the University of Maryland School of Medicine.
Eight patients have undergone the procedure so far at the Greenebaum Cancer Center, which is the first institution in the country to offer TheraSphere.
Primary liver cancer begins in the liver itself and has not spread from another part of the body. Its incidence in the U.S. is low with about 4,000 new cases a year, but that is expected to rise due to increasing infections of Hepatitis B and C viruses, which cause liver damage and can lead to cancer. Liver cancer is more prevalent in other parts of the world, such as sub-Saharan Africa and Southeast Asia, where it affects up to 10 percent of the population.
TheraSphere is administered through a catheter placed in the femoral artery in the upper thigh and threaded into the hepatic artery, a major blood vessel feeding the liver. There, millions of microscopic glass beads embedded with the radioactive element yttrium-90 are released into the blood and are transported directly to the tumor. TheraSphere treats the tumor with high doses of radiation over several days. Unlike external beam radiation treatments, TheraSphere’s targeting greatly reduces exposure of healthy tissues to delivered radiation. Patients can return home the same day and treatment poses no safety threat to caregivers and/or family members.
“This treatment can be given on an outpatient basis, which translates into increased patient comfort and convenience,” says Andrew Kennedy, M.D., a radiation oncologist at the University of Maryland Medical Center and an assistant professor of radiation oncology at the University of Maryland School of Medicine.
This past March, the U.S. Food and Drug Administration approved TheraSphere for the treatment of liver cancer that cannot be treated surgically, and granted its maker, MDS Nordion, a Humanitarian Device Exemption. This exemption encourages research and development of medical devices to treat diseases that affect small populations, which otherwise represent a limited market for medical device manufacturers. It permits the FDA to approve these devices based on proof of their patient safety alone. This, in turn, gives researchers like Dr. Van Echo early access to a new treatment like TheraSphere, and expedites studies of its effectiveness and quality of life benefits for liver cancer patients.
Surgical removal of liver cancer offers the best chance for a cure. Unfortunately, fewer than 15 percent of these patients are suitable surgical candidates, either because the cancer is too far advanced upon detection or because of other medical considerations.
Chemotherapy does not offer a significant survival rate. However, TheraSphere can be used in conjunction with chemotherapy, which may be more effective than either treatment alone. TheraSphere may also be of value as a “bridging” treatment for liver cancer patients awaiting a donor organ for liver transplantation, according to Dr. Van Echo.
CONTACT: Gwen Newman (gnewman@umm.edu)
Ellen Beth Levitt (eblevitt@umm.edu)
410-328-8919
Persons interested in more information about TheraSphere should call 1-800-492-5538 or visit the University of Maryland Greenebaum Cancer Center web site at www.umm.edu/cancer.