Boston Scientific has reported positive data from the TARGET study of the TheraSphere Y-90 Glass Microspheres in patients with hepatocellular carcinoma (HCC), a common type of primary liver cancer.
TheraSphere is a type of radioembolisation that consists of millions of microscopic glass beads containing radioactive yttrium (Y-90).
The global, retrospective TARGET study analysed the safety and efficacy of TheraSphere therapy in HCC patients using a dosing method called multicompartment dosimetry. This amplifies the dose of Y-90 reaching the tumour while lowering the radiation that reaches normal liver tissue.
The study retroactively used imaging software to calculate the dose delivered within each patient’s liver tissue.
Data confirmed that the treatment was safe and well-tolerated, with only 4.8% of subjects experiencing adverse events, defined in the primary endpoint as ≥ Grade 3 hyperbilirubinemia.
Furthermore, a link between the level of radiation absorbed by the tumour and an increase in survival probability through three years was observed, with a median overall survival of 20.3 months.
These results are consistent with previously published results which demonstrate that higher tumour absorbed dose leads to increased survival. A dose-efficacy relationship was also established, as the chance of tumour response was positively linked to the level of radiation absorbed.
Boston Scientific interventional oncology president Peter Pattison said: “TARGET adds to the robust body of evidence supporting TheraSphere as a safe and effective treatment option for the hundreds of thousands of patients around the world that are diagnosed with HCC each year.
“These study insights and the Simplicit90Y software provide physicians the opportunity to develop a personalised dosing approach for their patients with the potential to improve tumour response and optimise outcomes.”
Last week, the US Food and Drug Administration (FDA) granted approval to TheraSphere for treating HCC patients.
Boston Scientific noted that TheraSphere is the only radioembolisation technology in the US indicated for treating unresectable HCC.