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Comparative Effectiveness Review of Radioactive Yttrium-90 Microspheres for Treatment of Primary Unresectable Liver Cancer

June 11, 2019

Health Problem: Hepatocellular carcinoma (HCC) is the most common liver malignancy in the United States, accounting for approximately 90% of primary liver cancers. The definitive therapies for HCC are surgical resection, tumor ablation, and liver transplantation; however, most patients are not eligible for these therapies due to the overall burden or severity of their disease. As a result, patients require a range of locoregional and systemic therapies for HCC that is not amenable to curative approaches.

Technology Description: Transarterial radioembolization (TARE) with yttrium-90 (90Y) microspheres is an alternative treatment option that allows for much higher doses of radiation to be delivered to the diseased liver compared with an external beam approach. This treatment aims to achieve maximal tumor necrosis with minimal toxicity to normal tissues. There are currently 2 commercially available beta-emitting microsphere devices in which 90Y is incorporated: 1 device uses glass microspheres (TheraSphere; BTG International Ltd.) and the other uses microspheres made of resin (SIR-Spheres; Sirtex Medical Inc.).

Controversy: Until recently, there has been limited comparative evidence in the form of randomized trials that evaluate 90Y-radioembolization compared with TACE or other types of intra-arterial therapy for the treatment of patients with intermediate or advanced primary HCC.

Key Questions:

  • How does 90Y-TARE compare with other intra-arterial therapy (IAT) or targeted molecular therapy for treatment of primary unresectable liver cancer?
  • How does TARE delivered by TheraSphere compare with that delivered by SIR-Spheres?
  • Is TARE with 90Y safe?
  • Have definitive patient selection criteria been established for TARE with 90Y?