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

TheraSphere™ CLINICAL EVIDENCE

TARGET Study

TARGET study overview

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

The TARGET study confirms TheraSphere treatment for HCC as safe and effective in select patient populations. Predictable clinical outcomes from this real-world study span a broad group across 8 countries.

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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 and design

Establish the relationships between:

  • Normal tissue adsorbed dose (NTAD) and occurrence of grade 3 or higher hyperbilirubinemia
  • Tumour 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™ personalised dosimetry software to determine TAD and NTAD

*TheraSphere not indicated for patients with PVT.


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


Tumour 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 tumour 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 tumour 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


Tumour absorbed dose was predictive of overall survival

Kaplan-Meier overall survival curves

Total perfused tumour 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).
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Study takeaways


Dose matters

Deliver the highest dose to the tumour that is safely possible to maximise patient response and improve survival

Predictability

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

Consistency

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


Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.

TheraSphere is a registered trademark of Theragenics Corporation, used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation. Simplicit90Y is a registered trademark of Boston Scientific Medical Device Limited. Simplict90Y is developed by Mirada Medical Ltd. and used under license by Boston Scientific Corporation, the sales agent for Simplicit90Y. All rights reserved.