Patient case studies and technical considerations presented by a leading interventional radiologist and nuclear medicine physician at the European Association of Nuclear Medicine 2010 conference (Vienna, Austria 9 to 13 October 2010) suggest that the first large European study using Yttrium-90 (Y-90) glass microspheres published on the use of TheraSphere? (MDS Nordion), concludes that radioembolisation with TheraSphere? is both safe and effective, and states that the overall survival rate is similar to that found in another recently published large study analysing Y-90 glass microspheres for the treatment of Hepatocellular Carcinoma (HCC).
The publication, which currently can be viewed online and is expected to appear in the November 2010 edition of Hepatology.
About 50,000 cases of liver cancer are diagnosed each year in the European Union, with 31,000 of those cases in Germany, Italy, Austria, UK and France, according to the European Cancer Observatory (2008). Approximately, 600,000 cases are diagnosed each year globally. The most common form of primary liver cancer is hepatocellular carcinoma. Hepatocellular carcinoma is the fifth most common form of cancer in the world and is increasing globally due to an increase in the incidence of hepatitis.
Novel treatment
TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-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 tumour via blood vessels.
TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. MDS Nordion is approved (CE Mark) in Europe to distribute TheraSphere for treatment of hepatic neoplasia. MDS Nordion established a European TheraSphere Centre of Excellence in Essen, Germany to train and educate oncology professionals on the use of this innovative cancer treatment. In addition, there are multiple treatment centres across Europe, including the BCLC Group Hospital Clinic in Barcelona, Spain; Centre Eugene Marquis in Rennes, France; and Istituto Tumori in Milan, Italy.
TheraSphere treatment has some common side effects, including mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the common flu. Some patients will experience some loss of appetite and temporary changes in several blood tests.
Trial Results
Leading interventional radiologists and nuclear medicine physicians will discuss their experiences with the therapy and the options it offers liver cancer patients during EANM meeting in Vienna.
Conducted in Essen, Germany, the study involved 108 patients, none of whom were eligible for conventional locoregional therapies. Patients achieved a median overall survival of 16.4 months with minimal damage to the surrounding healthy tissue, even in patients with advanced liver cirrhosis or portal vein thrombosis. No lung or visceral toxicity was observed. The most frequently observed adverse event was a transient fatigue-syndrome.
Philip Hilgard, MD, hepatologist and lead author of the paper said, ?The outcomes of this study were not unexpected, but it was extremely important for us to be able to substantiate and verify the treatment here in Europe. We feel confident that the publication of our study will help towards giving more patients access to this advanced therapy.? The full study, entitled ?Radioembolisation with Yttrium-90 Glass Microspheres in Hepatocellular Carcinoma: European Experience on Safety and long term Survival? is available online here.
Peter Covitz, Ph.D., Senior Vice President, Innovation, MDS Nordion, commented: ?The patient outcomes reported in this study substantiate our belief that TheraSphere offers an important therapy option for advanced liver cancer patients. We look forward to working with more patients and oncologists to further advance the quality of liver cancer treatment in Europe.?
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) adds, ?Radioactive microspheres that can be targeted directly to the tumour via the arteries are a major scientific breakthrough for interventional oncology. We encourage further studies that will improve patient outcomes.?
Reference:
– Gastroenterology 2010; 138: 52-64.
