Preserve liver function while delivering significant survival benefits
TheraSphereTM Y90 Therapy has been shown to extend the survival of patients with HCC, particularly in cases where surgery or other treatments may not be suitable options. What is more, these benefits are obtainable without compromising on liver function.
Extend overall survival
Patients with solitary unresectable HCC
➣ 93% OS rate at 3 years in patients with transplant or resection following TheraSphere Y90 Therapy1
Pivotal LEGACY trial1
- Overall survival
- Summary
- Study design
Overall survival in treated population
- 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)
Treatment-naïve patients with unresectable HCC
➣ 12.5 years median OS in patients with transplant following TheraSphere Y90 Therapy2
15-year data, Gabr et al. 20212
- Overall survival
- Summary
- Study design
Overall survival of transplant patients
- 12.5 years median OS following liver transplant
(95% CI: 120–150)
Patients with unresectable locally advanced HCC
➣ Doubled median OS demonstrated in patients following TheraSphereY90 Therapy with personalised multi-compartment dosimetry3
DOSISPHERE-01 Level 1 evidence study3
- Overall survival
- Summary
- Study design
Overall survival in the intention-to-treat population
- 26.6 months median OS with personalised dosimetry
(95% CI: 11.7–not reached) - 10.7 months median OS in the standard dosimetry group
(95% CI: 6.0–16.8)
HR: 0.421 (95% CI: 0.215–0.826, P=0.0096)
23 months median OS for PVT patients in personalised arm vs 9.5 months in standard arm
16-month survival improvement
Patients with intermediate-stage HCC
➣ Doubled median OS found in patients following TheraSphere Y90 Therapy vs DEB-TACE4
Phase II TRACE trial4
- Overall survival
- Summary
- Study design
Overall survival in the intention-to-treat group
- 30.2 months median OS following TheraSphere Y90 Therapy
(95% CI: 19.4–41.0) - 15.6 months median OS following DEB-TACE
(95% CI: 6.0–16.8) - ITT group HR: 0.48
(95% CI: 0.28–0.82, P=0.006)
Preserve liver function
➣ Throughout the study follow-up period:
Liver function maintained in patients with solitary unresectable HCC following TheraSphere Y90 Therapy5
Pivotal LEGACY trial5
- Liver function
- Summary
- Study design
Did you know?
TheraSphere Y90 Therapy did not impart an increased risk for hepatic failure or encephalopathy in patients with branch or no PVT compared with main PVT6
Prolong progression-free survival
➣ >26 months of TTP in patients following TheraSphere Y90 Therapy vs cTACE13
Salem et al. 201613
- 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)
➣ 94% PFS at 2 years following TheraSphere Y90 Therapy as a bridging/downstaging treatment1
Progression-free survival in the LEGACY trial1
- Progression free survival
- Summary
- Study design
Progression free survival by transplantation/resection status
- 94% PFS at 2 years (localised RECIST)
➣ Doubled median TTP in patients following TheraSphere Y90 Therapy vs DEB-TACE4
Phase II TRACE trial4
- Time to progression
- Liver transplant
- Summary
- Study design
Time to overall tumour progression in the ITT group
- 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)
Provide better recurrence-free survival
➣ Liver transplant after TheraSphere Y90 Therapy proven to be a definitive curative therapy for HCC with a median RFS of 10 years2
15-year data, Gabr et al. 20212
- Recurrence-free survival
- Histopathology
- Summary
- Study design
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.Gabr A, et al. Liver Transplantation Following Yttrium-90 Radioembolization: 15-Year Experience in 207-Patient Cohort. Hepatology. 2021 Mar;73(3):998-1010.
3.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.
4.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.
5.Salem R, et al. 992P Yttrium-90 glass microspheres in the treatment of early and advanced hepatocellular carcinoma: The LEGACY study. Annal Oncol. 2020;31(SUPPLEMENT 4), S692-S693.
6.Kulik LM, et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology. 2008 Jan;47(1):71-81.
7.Salem R, et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology. 2011 Feb;140(2):497-507.e2.
8.Kim HC. Radioembolization for the treatment of hepatocellular carcinoma. Clin Mol Hepatol. 2017 Jun;23(2):109-114.
9.Mulcahy MF, et al. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907.
10.Salem R, Thurston KG. Radioembolization with 90Yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 1: Technical and methodologic considerations. J Vasc Interv Radiol. 2006 Aug;17(8):1251-1278.
11.Mazzaferro V, et al. Yttrium-90 Radioembolization for Intermediate-Advanced Hepatocellular Carcinoma: A Phase 2 Study. Hepatology. 2013;57(5):1826-1837.
12.Hilgard P, et al. Radioembolization with yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long-term survival. Hepatology. 2010 Nov;52(5):1741-1749.
13.Salem R, et al. Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Dec;151(6):1155-1163.e2.
Abbreviations
AE, adverse event; BCLC, Barcelona Clinic Liver Cancer; 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; 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.
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