Radiographically identified necrosis after 90Y microsphere brachytherapy: a new standard for oncologic response assessment?

摘要

This issue of AIR hosts two important studies on a rapidly evolving approach to the treatment of liver malignancies. Miller et al. explore the treatment of hepatic metastases from colorectal and other primary malignancies while Keppke et al. focus on hepatocellular carcinoma (HCC). Both studies used yttrium-90-im-pregnated microspheres. Currently there are two commercially available Y microsphere products: TheraSphere (MDS Nordion Inc.), which are glass microspheres, and SIR-Spheres (SIR-Tex Medical, Inc.), which are resin. The two products followed very different pathways to Federal Drug Administration (FDA) approval resulting in artificial dividing lines regarding their general use, clinical trials, and reported results. TheraSphere was approved as monotherapy (i.e., without concurrent chemotherapy) for HCC under the provisions of a humanitarian device exemption (HDE), whereas SIR-Spheres was granted premarket approval (PMA) for metastatic, unresectable liver tumors from primary colorectal cancer in combination with intraarterial 5-floxuridine chemotherapy.