Deliver better long-term outcomes with effective downstaging or bridging treatment1
TheraSphere 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.
Extend mOS to 12.5 years post liver transplant*1
Treatment-naïve patients with unresectable HCC
➣ 12.5 years mOS in patients with unresectable HCC who underwent liver transplants following bridging or downstaging with TheraSphere Y90 Therapy1
15-year data, Gabr et al. 20211
- Overall survival
- Summary
- Study design
Overall survival of transplant patients
- 12.5 years median OS following liver transplant
(95% CI: 120–150)
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 curative options
Patients with stage T3 unresectable HCC
➣ ~2x patients with unresectable HCC downstaged from stage T3 to T2 following TheraSphere Y90 Therapy vs cTACE, achieving transplant eligibility3
Lewandowski et al. 20093
- Downstaging
- Tumour reduction
- Summary
- Study design
Proportion of patients downstaged
This trend favouring TheraSphere Y90 Therapy for downstaging was maintained for all lesion sizes.
Lewandowski et al. 2009
• Retrospective
• Comparative
• Single centre (USA)
Patients with unresectable HCC
• Stage T3 disease
Prolong progression-free survival
Patients with early and intermediate HCC unfavourable for ablation and unresectable
➣ >26 months of TTP in patients following TheraSphere Y90 Therapy vs cTACE4
Salem et al. 20164
- Time to progression
- Summary
- Study design
Median time to progression comparison
- >26 months median TTP with TheraSphere Y90 Therapy
6.8 months median TTP with cTACE
HR: 0.122 (95% CI: 0.027–0.557; P=0.007)
Salem et al. 2016
• Phase II trial
• Randomised
• Prospective
• Open-label
• Single-centre (USA)
HCC patients unfavourable for ablation and unresectable
• BCLC A/B
• Bilirubin level ≤2.0 mg/dL
Bridge safely and promote future liver remnant
Patients who underwent surgical resection
➣ All patients with unilobar HCC achieved disease control following neoadjuvant TheraSphere Y90 Therapy4
➣ 77% of tumours showed more than 50% pathologic necrosis at resection4
Longitudinally clinical and radiological outcomes study, Gabr et al. 20185
- Future liver remnant
- Clinical outcomes
- Summary
- Study design
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
*From liver transplant, median OS was 12.5 years (95% CI:120-150).
References
1.Gabr A, al. Liver Transplantation Following Yttrium‐90 Radioembolization: 15‐year Experience in 207‐Patient Cohort. Hepatology 2021;73(3):998-1010.
2.DOSISPHERE-01: Garin E, 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. 2021 Jan;6(1):17-29.
3.Lewandowski RJ, et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant. 2009;9(8):1920-8.
4.Salem R, et al. Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma. Gastroenterology. 2016;151(6):1155-1163.e2.
5.Gabr A, et al. Outcomes of Surgical Resection after Radioembolization for Hepatocellular Carcinoma. J Vasc Interv Radiol. 2018;29(11):1502-1510.e1.
Abbreviations
BCLC, Barcelona Clinic Liver Cancer; CI, confidence interval; HCC, hepatocellular carcinoma; HR, hazard ratio; OS, overall survival; RFS, recurrence-free survival; TACE, transarterial chemoembolisation; TTP, time to progression; UNOS, United Network for Organ Sharing; Y90, yttrium-90.
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.
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