DOSISPHERE-01 Trial Summary.

DOSISPHERE-01 Trial Summary

Cancer Therapies & Ablation / TheraSphere / Personalized Therapy / DOSISPHERE-01
 

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


Study Design image.

Key Results


PERSONALIZED DOSIMETRY IMPROVED SURVIVAL

MEDIAN OVERALL SURVIVAL (ITT POPULATION)
Median Overall Survival (ITT population)

 

PERSONALIZED DOSIMETRY IMPROVED RESPONSE

INDEX LESION RESPONSE RATE AT 3 MONTHS USING EASL IN THE MITT POPULATION
Index Lesion Response Rate

 

PERSONALIZED DOSIMETRY DOWNSTAGED MORE PATIENTS TO SURGERY

PATIENTS SUCCESSFULLY DOWNSTAGED TO SURGERY
Overall Patient Population
36% of patients in the personalized arm were downstaged vs. 4% in the standardized arm
PVT Patient Population
44% of PVT patients in the personalized arm were downstaged vs. 0% in the standardized arm

 

DOSISPHERE-01 EDITORIAL

“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

PATIENT DEMOGRAPHICS (mITT population)

PATIENT DEMOGRAPHICS (mITT population)

TREATMENT CHARACTERISTICS AND DOSIMETRY (mITT population)

TREATMENT CHARACTERISTICS AND DOSIMETRY (mITT population)

LIVER ADVERSE EVENTS (Grade ≥3) Related to Y-90*

(Grade ≥3) Related to Y-90*
Liver Adverse Events.
* patients allocated to either PDA or SDA based on treatment received (dose received) versus allocation by randomization
  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

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.

PI-750208-AD

 
Top