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Landmark Study by Sirtex Medical to be presented at June ASCO next week:
Landmark Study Evaluates Sirtex SIR-Spheres(R) Microspheres in Patients with Metastatic Liver Cancer; International journal publishes results of largest U.S. study to-date on microspheres 25 May 2006 LAKE FOREST, IL, USA | May 25, 2006 | A new study, published in the June issue of the International Journal of Radiation Oncology Biology Physics, examines the use of Sirtex SIR-Spheres microspheres in patients with unresectable metastatic liver cancer. According to the study, the use of SIR-Spheres microspheres in patients with advanced liver disease resulted in a median survival of 10.5 months from treatment. Sirtex's SIR-Spheres microspheres are the only FDA-approved radioactive microspheres for treatment of metastatic liver tumors.
"This truly is a landmark study," says Dr. David Cade, medical director for Sirtex. "The opportunity to examine the efficacy of SIR-Spheres in such a large patient population is a milestone in liver cancer treatment. At Sirtex, we are committed to improving the lives of people with liver cancer, and this study is a major advancement toward providing the best patient care."
Of the nearly 150,000 Americans diagnosed with colorectal cancer every year, at least 80 percent will see their cancer spread to the liver. Less than 20 percent of liver tumors can be surgically resected. Metastatic liver cancer is often fatal, with up to 90 percent of patients dying from liver failure. Microspheres therapy has emerged as a treatment for patients with advanced liver cancer when most other treatment options have failed.
Although Sirtex's SIR-Spheres microspheres gained FDA approval in 2002, most studies to date have been relatively small in scope. The study published in the International Journal of Radiation Oncology Biology Physics followed 208 patients with unresectable liver metastases. Participants received high doses of radiation via Sirtex SIR-Spheres microspheres. SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of microspheres directly to the tumor site. The microspheres target the liver tumors, sparing healthy liver tissue.
In the study, participants were divided into two categories: responders and non-responders. Two thirds of study patients were classified as responders (median survival rate of 10.5 months) and one third of patients were non-responders (median survival 4.5 months). Researchers noted that the survival time of patients treated with SIR-Spheres was nearly double the rates of patients treated with systemic chemotherapy. There were no serious side effects reported, leading study authors to conclude that microspheres are a safe and effective treatment for patients with advanced liver disease.
"The ability to offer a patient with advanced liver cancer the possibility of an additional six months or more of life is remarkable," says Dr. Andrew Kennedy, lead author of the study and co-medical director of Wake Radiology Oncology in Cary, N.C. "For those of us using microspheres in our daily practice, we have seen how this therapy increases survival time and improves quality of life for our patients. The results of this study should further illustrate the efficacy of microspheres and encourage more physicians who treat liver cancer to train on the administration of microspheres and offer it to their patients."
Dr. Kennedy presented the findings of the study at the Second Annual Clinical Symposium on Liver Directed Radiotherapy with Microspheres held April 27-28 in Scottsdale, Ariz. Participants in the study were treated at seven different institutions from April 2002 to April 2005. Authors of the study include:
Andrew S. Kennedy, M.D., F.A.C.R.O. Stephen P. Loehr, M.D. Douglas Coldwell, M.D. Carroll Overton, M.D. Charles Nutting, D.O. Steven Meranze, M.D. Ravi Murthy, M.D., F.A.C.P. Jerry Niedzwiecki, M.D. Daniel E. Wertman, Jr., M.D. Scott Sailer, M.D.
Approximately 125 physicians in the United States use Sirtex's SIR-Spheres microspheres in more than 85 medical centers. The minimally invasive procedure is performed on an out-patient basis with minor side effects.
About Sirtex
SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. For more information, visit www.sirtex.com.
SOURCE: Sirtex
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