HCC patient looking up

For your patients with
unresectable hepatocellular carcinoma

Neoadjuvant TheraSphereTM Y90 Therapy

EMBRACE
THE POWER OF TIME

Deliver effective downstaging and bridging treatment

Patient laying on hospital bed

TheraSphereTM Y90 Therapy not only provides you and your patients with time to bridge to future treatments, but can allow downstaging of the tumour to access curative surgery options.

Provide better disease control

➣ >3/4 of HCC patients had a response that lasted more than 6 months following TheraSphere Y90 Therapy as a primary treatment1

Pivotal LEGACY trial1

Duration of response >6 months*

Pivotal LEGACY trial - Duration of response
Pivotal LEGACY trial-Summary

LEGACY trial (Salem et al. 2021)

• Multicentre
• Single-arm
• Retrospective

Patients with solitary unresectable HCC
• Tumour size <8 cm
• Child-Pugh A
• 60% BCLC A, 40% BCLC C
• ECOG 0-1

Access the full LEGACY trial

➣ 72% chance of being free from target lesion progression at Year 5 following TheraSphere Y90 Therapy2

Evidence in early-stage HCC from Lewandowski et al. 20182

Local tumour control rate at 5 years

Evidence in early-stage HCC from Lewandowski et al. 2018
Evidence in early-stage HCC from Lewandowski et al. 2018 -Summary

Lewandowski et al. 2018

• Retrospective analysis
• Single-arm
• Single centre (USA)

Patients with solitary HCC not amenable to percutaneous ablation

• BCLC A
• Tumour size ≤5 cm

Access the full Lewandowski et al. 2018 publication

Promote future liver remnant

➣ All patients with unilobar HCC achieved disease control following neoadjuvant TheraSphere Y90 Therapy3
➣ 77% of tumours showed more than 50% pathologic necrosis at resection3

Longitudinally clinical and radiological outcomes study Gabr et al. 20183

Longitudinally clinical and radiological outcomes study Gabr et al. 2018
Longitudinally clinical and radiological outcomes study Gabr et al. 2018 - Clinical outcomes
Longitudinally clinical and radiological outcomes study Gabr et al. 2018 - Summary

Gabr et al. 2018

• Retrospective
• Single centre (USA)

Patients with unilobar HCC
• Preserved liver function
• Child-Pugh ≤ B7
• No portal vein thrombus or metastatic disease

Access the full Gabr et al. 2018 publication

Effectively downstage more patients

➣ ~2x patients with unresectable HCC
downstaged from stage T3 to T2 following TheraSphere Y90 Therapy vs cTACE4

Lewandowski et al. 20094

Proportion of patients downstaged

Lewandowski et al. 2009- Downstaging

This trend favouring TheraSphere Y90 Therapy for downstaging was maintained for all lesion sizes.

Lewandowski et al. 2009 - Tumour reduction
Lewandowski et al. 2009 - Summary

Lewandowski et al. 2009

• Retrospective
• Comparative
• Single centre (USA)

Patients with unresectable HCC
• Stage T3 disease

Access the full Lewandowski et al. 2009 publication

➣ Long-term data: ~2/3 of patients received liver transplant after downstaging from stage T3 to T2 with TheraSphere Y90 Therapy5

15-year data from Gabr et al. 20215

Tumour characteristics at TheraSphere Y90 Therapy and transplant

15-year data from Gabr et al. 2021-Downstaging

This trend favouring TheraSphere Y90 Therapy for downstaging was maintained for all lesion sizes.

15-year data from Gabr et al. 2021-Tumour Stage
15-year data from Gabr et al. 2021-Summary

Gabr et al. 2021

• Phase II trial
• Randomised
• Prospective
• Open-label
• Single-centre (USA)

Patients with HCC undergoing liver transplant following downstaging or bridging with TheraSphere Y90 Therapy
• Treatment-naïve (79.5%)
• 51% BCLC A; 31% BCLC C

Access the full Gabr et al. 2021 publication

➣ >2x HCC patients initially not amenable to curative treatment downstaged to liver transplant following TheraSphere Y90 Therapy vs DEB-TACE6

Phase II TRACE trial6

Time to overall tumour progression in the ITT group

Phase II TRACE trial - Time to progression
  •  17.1 months median TTP with TheraSphere Y90 Therapy
    (95% CI: 8.9–25.4)
  • 9.5 months median TTP with DEB-TACE
    (95% CI: 8.8–10.2)
  • HR: 0.36
    (95% CI: 0.18–0.70; P=0.002)
Phase II TRACE trial - Liver transplant
Phase II TRACE trial - Summary

TRACE trial (Dhondt et al. 2022)

• Phase II trial
• Open-label
• Single-centre (Belgium)
• Randomised
• Controlled

Patients with HCC not amenable to curative treatment

• BCLC A/B
• ECOG PS 1
• Segmental PVT

Access the full TRACE trial

Bridge to gain time

➣ 98% of HCC patients undergoing liver transplant remained within Milan criteria following bridging with TheraSphere Y90 Therapy5

Long term evidence in Gabr et al. 20215

Long term evidence in Gabr et al. 2021-Bridging
Long term evidence in Gabr et al. 2021-Milan Criteria
Long term evidence in Gabr et al. 2021-Summary

Gabr et al. 2021

• Phase II trial
• Randomised
• Prospective
• Open-label
• Single-centre (USA)

Patients with HCC undergoing liver transplant following downstaging or bridging with TheraSphere Y90 Therapy
• Treatment-naïve (79.5%)
• 51% BCLC A; 31% BCLC C

Access the full Gabr et al. 2021 publication

➣ 93% OS rate at 3 years in patients with transplant or resection following TheraSphere Y90 Therapy1

Pivotal LEGACY trial1

Overall survival in treated population

Pivotal LEGACY trial-Overall survival
  • 93% of patients alive following liver transplant or resection
    (95% CI: 74.2–98.2)
  • 86.6% of all patients alive following TheraSphere Y90 Therapy
    (95% CI: 78.2–92.0)
Pivotal LEGACY trial-Summary

LEGACY trial (Salem et al. 2021)

• Multicentre
• Single-arm
• Retrospective

Patients with solitary unresectable HCC
• Tumour size <8 cm
• Child-Pugh A
• 60% BCLC A, 40% BCLC C
• ECOG 0-1

Access the full LEGACY trial

References

1.Salem R, et al. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable HCC: The LEGACY Study. Hepatology. 2021 Nov;74(5):2342-2352.

2.Lewandowski RJ, et al. Radiation Segmentectomy: Potential Curative Therapy for Early Hepatocellular Carcinoma. Radiology. 2018 Jun;287(3):1050-1058.

3.Gabr A, et al. Outcomes of Surgical Resection after Radioembolization for Hepatocellular Carcinoma. J Vasc Interv Radiol. 2018 Nov;29(11):1502-1510.e1.

4.Lewandowski RJ, et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant. 2009 Aug;9(8):1920-1928.

5.Gabr A, et al. Liver Transplantation Following Yttrium-90 Radioembolization: 15-Year Experience in 207-Patient Cohort. Hepatology. 2021 Mar;73(3):998-1010.

6.Dhondt E, et al. 90Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial. Radiology. 2022 Jun;303(3):699-710. 

Abbreviations

AE, adverse event; BCLC, Barcelona Clinic Liver Cancer; BICR; Blinded independent central review; CI, confidence interval; EASL, European Association for the Study of the Liver; ECOG, Eastern Cooperative Oncology Group; HCC, hepatocellular carcinoma; HR, hazard ratio; ITT, intention to treat; LT, liver transplant; mRECIST, modified Response Evaluation Criteria in Solid Tumors; ORR, objective response rate; OS, overall survival; PVT, portal vein thrombosis; RFS, recurrence-free survival; TACE, transarterial chemoembolisation; TTP, time to progression; UNOS, United Network for Organ Sharing; Y90, yttrium-90.

people with headset icon
Get in contact with your local Boston Scientific Representative

Contact us

icon_TheraSphere
Access the product page

TheraSphereTM Y90 

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.