Nordion, Inc. recently shared results from their first multi-site, Phase II clinical trial of TheraSphere® for treatment of metastatic liver cancer. The trial evaluated a variety of factors, including safety and tumor response, in patients with liver metastases. The overall tumor response, including stable disease, was 90 percent in metastatic neuroendocrine tumors and 69.2 percent in all treatment groups.Initial analysis of the trial data led the researchers to suggest that TheraSphere is a safe, well-tolerated treatment for patients with liver metastases.
Dr. Riad Salem of Northwestern University in Chicago, presented the findings at the annual scientific meeting of the Society of Interventional Radiology (SIR) in Chicago. The Global Principal Investigator was Dr. Al Benson III of Northwestern. The trial ran from 2007 to 2011 and involved 151 patients at five institutions. “We are extremely pleased with the consistency of the results across all treating institutions,” said Dr. Peter Covitz, Nordion’s Senior Vice-President of Innovation.
TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the main artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumor via blood vessels. TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. It is also 100 percent reimbursed by Medicare and used to treat patients with unresectable hepatocellular carcinoma (HCC), and can be used as a bridge to surgery or transplantation. Another application includes treatment for primary liver cancer patients with portal vein thrombosis. TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Use Device (HUD) exemption.
Side effects can include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests.