TheraSphere™ Y-90 Glass Microspheres

DOSISPHERE-01 trial

DOSISPHERE-01 overview

Phase 2 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

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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.

Process chart with 93 patients screened, 74 patients screened, treatment and follow-up assessments (efficacy, safety).

Personalized dosimetry improved survival

Median overall survival (ITT population)

Chart showing 16 month survival improvement (personalized vs. standard dosimetry) and 22.9 month overall survival for PVT patients in personalized arm vs. 9.5 months in standard arm.

Personalized dosimetry improved response

Index lesion response rate at 3 months using EASL in the MITT population

Chart showing Primary Study Endpoint of 71.4% Objective Response Rate (personalized vs. 35.7% in standard dosimetry).

Personalized dosimetry downstaged more patients to surgery

Patients successfully downstaged to surgery

Chart showing 36% of patients in the personalized arm were downstaged vs. 4% in the standardized arm.

36% of patients in the personalized arm were downstaged vs. 4% in the standardized arm

Chart showing 44% of PVT patients in the personalized arm were downstaged vs. 0% in the standardized arm.

44% of PVT patients in the personalized arm were downstaged vs. 0% in the standardized arm

"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 (i.e., 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)

Table with Parameter, PDA (n=28) and SDA (n=28), with data on Male (%), Child-Pugh status (%), BCLC (%), Bilobar (5), Mean total Bilirubin (μM/L+-SD), PVT present (%), PVT location (%), Index lesion (mean, cm).

Treatment characteristics and dosimetry (mITT population)

Table with Investigator Assessments, PDA (n=28), SDA (n=28), Pvalue, with data on Number of Y-90 glass microsphere treatment, Activity administered GBq, Absorbed Dose to perfused liver Mean, % of patients with AD to perfused liver >150 Gy, AD to index lesion Mean, % of patients with AD to index lesion >205 Gy, AD to perfused normal tissue Mean.

*AD = absorbed dose

Liver adverse events (grade ≥3) related to Y-90*

Table with PDA (n=36) and SDA (N=21) with data on Patients with >=1 AE, Death, Liver AEs.

*patients allocated to either PDA or SDA based on treatment received (dose received) versus allocation by randomization

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

Boston Scientific is not responsible for the collection, analysis or reporting of the investigator-sponsored research output which is the sole responsibility of the investigators. Boston Scientific’s involvement in investigator-sponsored research is limited to providing financial support for research that advances medical and scientific knowledge about our products. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

TheraSphere indications, safety, and warnings

TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation.