DOSISPHERE-01 Trial Summary.
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DOSISPHERE-01 Trial Summary

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

This Level 1 (i.e., prospective and randomized) clinical trial demonstrated that personalized TheraSphere dosimetry, using multicompartamental dose administration, achieved a 26.6 month median OS for large tumor HCC patients and a 16-month survival improvement compared to the control arm on standard dosimetry.

Garin, E , Tselikas L, Guiu B et al. Personalised 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 2020; Published Online: November 06, 2020 https://doi.org/10.1016/S2468-1253(20)30290-9



“Personalized dosimetry is safe and leads to a meaningful improvement in the objective response rate and overall survival of patients with locally 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 advanced HCC using two pre-treatment dosimetry determination methods: (1) Standard, single-compartment dosimetry (STD); defined as a uniform distribution of absorbed dose within the perfused volume – both tumor and normal liver or (2) Personalized dosimetry (PERSO); 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 Improves Survival

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

 

Personalized Dosimetry Improves Response

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

 

Personalized Dosimetry Downstages 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 advanced hepatocellularcarcinoma should have systemic therapy at the expense of locoregional therapy. This notion is particularly true for patients with large tumours and local vascular invasion.”1

–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*
  PAD (n=35) SDA (N=21)
Patients with ≥ 1 AE 3 (8.6%) 3 (14.3%)
Death 1 (2.9%) 1 (4.8%)
Liver AEs 4 (11.4%) 5 (23.8%)
  Ascites 1 (2.9%) 2 (9.5%)
  Encephalopathy 0 0
  GI hemorrhage 0 2 (9.5%)
  Bilirubin increase/jaundice 1 (2.9%) 2 (9.5%)
  Hepatic failure 2 (5.7%) 0
* patients allocated to either PDA or SDA based on treatment received (dose received) versus allocation by randomization

1. 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

PI-750208-AC

 
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