DOSISPHERE-01 Trial Summary

Level I randomized trial showed that advanced HCC patients who received a personalized TheraSphere dose using multicompartment dosimetry had a median OS of 26.6 months– a 16-month improvement compared to the control arm.

Garin E, Tselikas L, Guiu B et al. Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01):a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021, 6: 17-29

“Personalized dosimetry is safe and leads to a meaningful improvement in the objective response rate and overall survival ofpatients with locally intermediate/advanced hepatocellular carcinoma [...] when compared with standard dosimetry.”

 

Study Objective and Design

A randomized, multicenter, investigator sponsored phase II trial comparing the clinical outcomes of SIRT with TheraSphere in patients with intermediate/advanced HCC using two pre-treatment dosimetry determination methods: (1) Standard, single-compartment dosimetry (SDA); defined as a uniform distribution of absorbed dose within the perfused volume – both tumor and normal liver or (2) Personalized dosimetry (PDA); defined as multi-compartment Y-90 distribution of absorbed dose within the perfused volume that accounts for preferential blood flow into the tumor compared with normal parenchyma.

Study Design

“The DOSISPHERE-01 Study challenges the evolving narrative that patients with advancedhepatocellular carcinoma should have systemic therapy at the expense of locoregional therapy. […]Personalized dosimetry (ie, reaching specific threshold radiation doses) is a natural evolution ofselective internal radiation therapy with ⁹⁰Y-labelled microspheres..”³

–Robert J Lewandowski, MD, Riad Salem, MD, DOSISPHERE Editorial, Lancet Gastroenterology & Hepatology

1. Reasons for censoring: received another anti-cancer treatment before M3 evaluation (n=2), no evaluation at M3 evaluation (n=1) (10.7%)
2. Reasons for censoring: early deaths (before M3) (n=2), no evaluation at M3 (n=1), start another anti-cancer treatment before M3 evaluation (n=1) (14.3%)
3. Lewandowski, Robert J, Salem, Riad. Radioembolisation with personalised dosimetry: improving outcomes for patients with advanced hepatocellular carcinoma. Lancet Gastroenterol Hepatol 2020; Published Online: November 06, 2020 https://doi.org/10.1016/S2468-1253(20)30306-X

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