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 of patients 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.
PERSONALIZED DOSIMETRY IMPROVED RESPONSE
PERSONALIZED DOSIMETRY DOWNSTAGED MORE PATIENTS TO SURGERY
“The DOSISPHERE-01 Study challenges the evolving narrative that patients with advanced hepatocellular carcinoma should have systemic therapy at the expense of locoregional therapy. […]Personalized dosimetry (ie, reaching specific threshold radiation doses) is a natural evolution of selective internal radiation therapy with ⁹⁰Y-labelled microspheres..”3
–Robert J Lewandowski, MD, Riad Salem, MD, DOSISPHERE Editorial, Lancet Gastroenterology & Hepatology
PATIENT DEMOGRAPHICS (mITT population)
TREATMENT CHARACTERISTICS AND DOSIMETRY (mITT population)
LIVER ADVERSE EVENTS (Grade ≥3) Related to Y-90*
- Reasons for censoring: received another anti-cancer treatment before M3 evaluation (n=2), no evaluation at M3 evaluation (n=1) (10.7%)
- 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%)
- 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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