The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma

OBJECTIVES:

• Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
• Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
• Determine the toxic effects and adverse experiences associated with this therapy in these patients.
• Determine the survival time of patients treated with this therapy.
• Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
• Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
• Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.