Review Examines the Use of Sirtex's SIR-Spheres(R) Microspheres in Patients with Hepatic Colorectal Cancer Metastases.

Review of Clinical Data Published in July Issue of Archives of Surgery 

WILMINGTON, Mass. -- A review article, published in the July issue of Archives of Surgery, an international peer-reviewed journal, examines the use of Sirtex's SIR-Spheres([R]) microspheres in patients with hepatic colorectal cancer metastases. According to the review, the use of SIR-Spheres microspheres is effective in improving response rates and extending survival times in patients with colorectal cancer liver metastases. Sirtex's SIR-Spheres microspheres are currently FDA approved to treat colorectal cancer that has spread to the liver.1

Seza A. Gulec, M.D., F.A.C.S., director of the Goshen Cancer Institute Hepatic Oncology Program at Goshen Health System, and Yuman Fong, M.D., chief of gastric and mixed tumor service at Memorial Sloan Kettering Cancer Center, partnered to discuss the basic concepts involved in development of Yttrium 90 (Y-90) microsphere Selective Internal Radiation Therapy (SIRT) and review clinical data pertaining to its application.

Using retrospective data from several studies, including a Phase III randomized study of patients with metastatic colorectal cancer liver metastases, the oxaliplatin dose-escalation study, retrospective data from New Zealand, and U.S. experience, Gulec and Fong concluded that SIRT is a promising therapy in the treatment of patients with hepatic colorectal cancer metastases as part of a multimodality approach.

"This review is important because it not only reinforces the efficacy of SIRT, but also provides insight into how we can best treat metastatic liver tumors," says Gulec. "By combining chemotherapy with SIRT, this approach has the potential to improve therapeutic outcomes by maximizing the effectiveness of both modalities."

The authors concluded that clinical studies in neoadjuvant and salvage settings are needed for more concrete outcome data and design of optimal multimodality treatment strategies. For reprints of the article, visit http://archsurg.ama-assn.org.

1Sirtex Medical Inc.'s SIR-Spheres([R]) microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device that is presented in peer-reviewed literature is different from the approved USA labeling for SIR-Spheres.

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres

Selective Internal Radiation Therapy (SIRT) is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

SIRT using SIR-Spheres microspheres is approved for use in Australia, New Zealand, the United States of America (FDA approval), European Union (CE Mark), Hong Kong, Malaysia, Singapore, Thailand, Israel and India. SIRT is available in 140 treatment centers around the world, and more than 6,500 patients have been treated to date.

Approximately 90 physicians in the United States use Sirtex's SIR-Spheres microspheres in more than 86 medical centers. For more information, visit www.sirtex.com.

[R] SIR-Spheres is a Registered Trademark of Sirtex SIR-Spheres Pty Ltd