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TheraSphere™ Y-90 Glass Microspheres

Clinical data

Durability leads to better patient quality of life

TheraSphere Y-90 glass microspheres deliver durable patient outcomes and reproducible results to you and your multi-disciplinary team, while also preserving patient quality of life.

  • Clinical data since 1999 shows TheraSphere is a proven, evidence-based therapy across different HCC stages, with more than 100,000 patient treatments globally. Watch the evolution of TheraSphere data.
  • With clinical studies enrolling more than 2,000 patients worldwide, TheraSphere has demonstrated success in providing patients more options with longer time to progression and better quality of life.
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Reproducible results backed by Dosimetry Steering Committee recommendations

Key updates from an international multidisciplinary working group provide dosing recommendations based on contemporary clinical data, including results from TheraSphere landmark studies LEGACY, TARGET and DOSISPHERE-01 Trial.

5 treatment scenarios of therasphere
See the 5 clinical scenarios
Salem, R., Padia, S.A., Lam, M. et al. Clinical, dosimetric, and reporting considerations for Y-90 glass microspheres in hepatocellular carcinoma: updated 2022 recommendations from an international multidisciplinary working group. Eur J Nucl Med Mol Imaging 50, 328 -343 (2023). https://doi.org/10.1007/s00259-022-05956-w

93% OS

Overall Survival rate in patients with transplant or resection following TheraSphere at 3 years in the LEGACY study.1

26.6 months

Overall survival in patients with advanced HCC who received TheraSphere in the DOSISPHERE-01 study using multicompartment dosimetry.2

20.3 months

Median overall survival after the use of TheraSphere for HCC in the TARGET study, demonstrating efficacy in this patient population and predictable clinical outcomes.3

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TheraSphere data spans the BCLC

Barcelona Clinic Liver Cancer (BCLC) guidelines for HCC include Transarterial Radioembolization (TARE/Y-90) for very early stage (0) and early stage (A) patients.⁴ These guidelines influence clinical decision-making and are based on LEGACY Study results.

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  • 1999 TheraSphere receives FDA HDE approval
  • 2004 Advanced HCC with or without PVT5
  • 2006 Downstaging and bridging to transplant6
  • 2009 Radiation lobectomy: local tumor shrinkage and hypertrophy of normal liver7
  • 2011 Radiation segmentectomy: high-dose radiation delivered to ≤ 2 hepatic segments8
  • 2016
    PREMIERE: TheraSphere Y-90 significantly prolongs time to progression compared with cTACE* in HCC patients9
  • 2018 Curative intent: early HCC and low tumor burden10
  • 2020 Legacy confirms neoadjuvant or standalone treatment in HCC12 Dosisphere-01 personalized dosimetry approach improves overall survival11
  • 2021 PMA: 1st and only Y-90 therapy approved by FDA for HCC
  • 2021 Target: global real-world study confirms tumor absorbed dose is critical for predictable tumor response and OS in broad population3
  • 2021 BCLC Guidelines: LEGACY study led to inclusion of TARE for very early and early-stage unresectable HCC4
  • 2022 RASER Prospective study assessing radiation segmentectomy using TheraSphere Y-9013

    TRACE: TheraSphere Y-90 offers superior tumor control and survival compared with DEB-TACE* in HCC patients 14

1999: TheraSphere receives FDA HDE approval • 2004: Advanced HCC with or without PVT 5 • 2006: Downstaging and bridging to transplant 6 • 2009: Radiation lobectomy: local tumor shrinkage and hypertrophy of normal liver 7 • 2011: Radiation segmentectomy: high-dose radiation delivered to ≤ 2 hepatic segments 8 • 2016: PREMIERE: TheraSphere Y-90 significantly prolongs time to progression compared with cTACE* in HCC patients ⁹  • 2018: Curative intent: early HCC and low tumor burden 10 • 2020: Legacy confirms neoadjuvant or standalone treatment in HCC 12 Dosisphere-01 personalized dosimetry approach improves overall survival 11 • 2021: PMA: 1st and only Y-90 therapy approved by FDA for HCC • 2021: Target: global real-world study confirms tumor absorbed dose is critical for predictable tumor response and OS in broad population 3 • 2021: BCLC Guidelines: LEGACY study led to inclusion of TARE for very early and early-stage unresectable HCC 4 • 2022: RASER Prospective study assessing radiation segmentectomy using TheraSphere Y-90 13 • TRACE: TheraSphere Y-90 offers superior tumor control and survival compared with DEB-TACE* in HCC patients ¹⁴

*The loading of doxuribicin to LC Beads is outside of the indication for use in the USA

References

  1. Salem R, Johnson GE, Kim E, Riaz A, Bishay V, Boucher E, Fowers K, Lewandowski R, Padia SA. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable Hepatocellular Carcinoma: The LEGACY Study. Hepatology. 2021 Mar 19. doi: 10.1002/hep.31819.
  2. Garin E, Tselikas L, Guiu B et al. Personalized 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, 6: 17-29
  3. 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.
  4. Reig M, Forner A, Rimola J, et al. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2021;S0168-8278(21)02223-6. doi:10.1016/j.jhep.2021.11.018.
  5. Salem R, Lewandowski R, Roberts C et al. J Vasc Interv Radiol. 2004; 15(4) 335-45
  6. Kulik LM, Atassi B, van Holsbeeck L et al. J Surg Oncol. 2006;94: 572-586
  7. Gaba RC, Lewandowski RJ, Kulik LM et al. Ann Surg Oncol. 2009 Jun;16(6):1587-96
  8. Riaz A, Gates VL, Atassi B et al. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71
  9. Salem R, Gordon AC, Mouli S, et al. Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma. Gastroenterology. 2016;151(6):1155-1163.e2. doi:10.1053/j.gastro.2016.08.029
  10. Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiology. 2018;287(3) epub
  11. Garin et al, J Clin Oncol 38, 2020 (suppl 4; abstr 516)
  12. 3020.2: Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma: The LEGACY Study,” CIRSE 2020 Virtual Summit, September 12-15, 2020; Salem R, Johnson GE, Kim E, Riaz A, Bishay V, Boucher E, Fowers K, Lewandowski R, Padia SA. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable Hepatocellular Carcinoma:The LEGACY Study. Hepatology. 2021 Mar 19. doi: 10.1002/hep.31819.
  13. Kim E, Sher A, Abboud G, et al. Radiation segmentectomy for curative intent of unresectable very early to early stage hepatocellular carcinoma (RASER): a single-centre, single-arm study [published online ahead of print, 2022 May 23]. Lancet Gastroenterol Hepatol. 2022;S2468-1253(22)00091-7. doi:10.1016/S2468-1253(22)00091-7
  14. Dhondt E, Lambert B, Hermie L, et al. 90Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial. Radiology. 2022;303(3):699-710. doi:10.1148/radiol.211806

*Refers to HCC or associated tumors.

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.