NCCN Guidelines Recommend SIR-Spheres Y-90 Resin Microspheres to Treat Metastatic Colorectal Cancer
December 12, 2016—Sirtex Medical Limited announced that the company's SIR-Spheres yttrium-90 (Y-90) resin microspheres have been included as a category 2A recommended treatment in the latest National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology for colon cancer and rectal cancer.
Sirtex Medical stated that this designation denotes that there is uniform consensus among the NCCN panel that selective internal radiation therapy (SIRT) with Y-90 microspheres is an appropriate option in patients with liver-dominant, chemotherapy-resistant metastatic colorectal cancer (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens. The new guidelines are available online on the NCCN website.
According to Sirtex Medical, the MORE study, which was a large retrospective analysis conducted in the United States with SIR-Spheres Y-90 resin microspheres in more than 600 mCRC patients, helped to increase the understanding of SIRT as a treatment option for patients who have failed multiple lines of chemotherapy while highlighting the positive aspects of the safety and efficacy of the protocol for patients of all ages.
The MORE study was published by Andrew S. Kennedy, MD, et al in the Journal of Gastrointestinal Oncology (2015;6:134–142). Dr. Kennedy, who is Director, Radiation Oncology Research at Sarah Cannon Research Institute in Nashville, Tennessee, served as Lead Investigator of the MORE study.
In the Sirtex Medical's announcement, Dr. Kennedy commented, “Clinical research has shown that SIRT brings patients with colorectal liver metastases improved and prolonged quality of life. We look forward to expanding access to this outpatient procedure, which has demonstrated minimal side effects, to improve outcomes for this population of patients and advance the standard of care.”
Sirtex Medical advised that SIR-Spheres Y-90 resin microspheres have received US Food and Drug Administration premarket approval for the treatment of nonresectable metastatic liver tumors from primary colorectal cancer in combination with intrahepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union, Argentina, Brazil, Canada, and several countries in Asia, such as India and Singapore.