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JAMA. 2002;287:2203.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved SIR-Spheres (Sirtex Medical Inc, New South Wales, Australia) for the treatment of unresectable metastatic liver tumors from primary colorectal cancer together with intrahepatic artery chemotherapy with floxuridine.

The approved device consists of biocompatible microspheres containing yttrium-90 of 20 to 40 µm in diameter. It is implanted into a hepatic tumor by injection into either the common hepatic artery or the right or left hepatic artery via a chemotherapy catheter port. SIR-Spheres distribute unevenly in the liver, and its density in the tumor can be as much as five or six times that in normal liver tissue. The product remains permanently in the liver.

SIR-Spheres was approved on the basis of the results of a randomized controlled clinical trial with 70 patients, 34 of whom received floxuridine and 36 of whom received floxuridine and SIR-Spheres. When measured with two consecutive computerized tomography (CT) scans in a 3-month . . . [Full Text of this Article]