TheraSphere™

Y-90 Glass Microspheres

DOSISPHERE-01 Trial

Level 1 evidence from the DOSISPHERE-01 Trial showed a 16 month overall survival improvement in hepatocellular carcinoma (HCC) patients treated with TheraSphere using personalized dosimetry compared to standard dosimetry

Presented at ASCO GI 2020

Dosisphere-01 Trial Median Overall Survival ITT Population chart.

PDA: Personalized dosimetry
SDA: Standard, single-compartment dosimetry

DOSISPHERE-01 Trial: A prospective, randomized, multi-center, investigator-sponsored phase II trial that looked at HCC patients (n-56) treated with TheraSphere using either personalized dosimetry (defined as multi-compartment Y-90 distribution that targets ≥205 Gy to the index lesion and ≤120 Gy in the treated normal liver) or standard dosimetry (defined as single-compartment dosimetry of 120 +/- 20 Gy absorbed dose to the treated liver). 

In the trial, TheraSphere patients treated with the personalized dosimetry approach reached an overall survival rate of 26.7 months versus 10.7 months for those patients receiving standard, single-compartment dosimetry (HR: 0.421, p=0.0118).

Top