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Internal view of patient's torso demonstrating targeted accuracy of TheraSphere Y-90 Glass Microspheres in liver.

TheraSphere™ Y-90 Glass Microspheres

TARGET Study

TARGET study overview

A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study.

A real-world retrospective study that confirms TheraSphere for HCC as safe and effective in a select patient population, demonstrating predictable clinical outcomes across a broad patient population in 8 countries.

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TARGET_Data_Sheet.pdf
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Download TARGET study analysis

Lam, M., Garin, E., Maccauro, M. et al. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging (2022). https://doi.org/10.1007/s00259-022-05774-0.

Study objective

Establish the relationships between:

  • Normal tissue adsorbed dose (NTAD) and occurrence of grade 3 or higher hyperbilirubinemia
  • Tumor absorbed dose (TAD) and Objective Response Rate (ORR)
  • TAD and Overall Survival (OS)

Study design

Key patient characteristics

  • Mainly Intermediate and Advanced HCC: 32.5% BCLC B and 54.5% BCLC C
  • 7cm median target lesion
  • 33% PVT

Dosimetry approach

  • Investigator review of patient chart and dosimetry calculation
  • Retrospective dosimetry evaluation with multi-compartment approach using Simplicit90Y™ personalized dosimetry software to determine TAD and NTAD

Results

Graph showing Median OS: 20.3 months (95% CI: 16.7-26.4 months), measuring survival probability over time (in months).

70.8% ORR*

for the target lesion (mRECIST)

61.7% OR**

for all lesions (mRECIST)

20.3 months

median overall survival

*95% CI 64.3, 76.6
**95% CI 55.0, 68.0


Tumor absorbed dose was predictive of response¹ ²

Graph showing partial response % and complete response %, comparing <200, >=200 to <300, Tumor Absorbed Does (GY), and >+300.
  1. Total perfused tumor absorbed dose (CT/MRI workflow) and best response (61.7%) according to mRECIST.
  2. Non-responders (defined as stable disease, progressive disease, or non-evaluable) are not represented in the graph.

Responders had a

17% higher

mean tumor absorbed dose (225.5 Gy*) compared with non-responders (188.3 Gy**)

*95% CI 201.0 - 253.0 Gy
**95% CI 164.6 - 215.3 Gy; p = 0.046


Tumor absorbed dose was predictive of overall survival

Kaplan-Meier overall survival curves

Total perfused tumor absorbed dose by subgroups

Graph showing overall survival rate (%) over time (in months).

Median overall survival

>300 Gy - 36.7 months
(95% CI: 20.2 - 43.9 months)

>200 - <300 Gy - 25.1 months
(95% CI: 14.5 - 32.9 months)

<200 Gy - 16.1 months
(95% CI: 11.3 - 19.4 months)


Low rate of ≥ grade 3 hyperbilirubinemia confirms safety of TARGET study

Graph showing Probability of >= Grade 3 Hyperbilirubinemia in the Absence of Disease Progression over Absorbed Dose (Gy).

Only 4.8% of patients (10/209) experienced ≥ Grade 3 hyperbilirubinemia in the absence of disease progression.

Regarding the low rate of event, no correlation could be established with the normal tissue absorbed dose (p=0.6 for NTAD).


Table on patient characteristics, parameter, and treated population (N-209) N (%); parameters are Median age (range), years, Gender, male, ECOG Status, BCLC Status, Child-Pugh Status, Unilobar or Bilobar Disease.
Table on patient characteristics, parameter, and treated population (N-209) N (%); parameters are With PVT, Location of Target Lesion, Target Lesion Longest Diameter (RECIST 1.1), Total Number of Lesions (target and non-target).

Study takeaways


Dose matters

Deliver the highest dose to the tumor that is safely possible to maximize patient response and improve survival

 

Predictability

Predictable results across 8 countries using multi-compartmental dosimetry using Simplicit90Y personalized dosimetry software

 

Consistency

Like the Legacy study and Dosisphere-01 trial results, the Target study reinforces the association between higher tumor absorbed dose and clinical outcomes

 

Double desktop monitor showing Simplicit90Y personalized dosimetry software for TheraSphere Y-90 Glass Microspheres.

Simplicit90Y™ personalized dosimetry software

Simplicit90Y is the only Y-90 personalized dosimetry software with FDA 510K  clearance, designed specifically for TheraSphere™ Y-90 Glass Microspheres.  Simplicit90Y was developed to accelerate dosimetry planning and improve your Y-90 Selective Internal Radiation Therapy (SIRT) workflow.

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