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Proven Results

Fight HCC. Maximize Outcomes.

Interventional Oncology / Cancer Therapies & Ablation / TheraSphere / Proven Results

 

Significant Investments Have Been Made to Advance Clinical Evidence With TheraSphere

The LEGACY Study

Learn how the LEGACY study confirms TheraSphere as a neoadjuvant or standalone therapy in treating HCC.

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The TARGET Study

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A global real-world retrospective study that confirms TheraSphere for HCC as safe and effective, demonstrating predictable clinical outcomes across a broad patient population in 8 countries.

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20 Years of Success in HCC Treatment

TheraSphere™ Y-90 Glass Microspheres are a proven, evidence-based HCC therapy that hits tumors hard. Now you have the power to reliably shrink and destroy tumors and enhance outcomes. 

  • 1999 TheraSphere receives FDA HDE approval
  • 2004 Advanced HCC with or without PVT1
  • 2006 Downstaging and bridging to transplant2
  • 2009 Radiation lobectomy: local tumor shrinkage and hypertrophy of normal liver3
  • 2011 Radiation segmentectomy: high-dose radiation delivered to ≤ 2 hepatic segments4
  • 2014 Radiation segmentectomy threshold dose >190 Gy5
  • 2018 Curative intent: early HCC and low tumor burden6
  • 2020 Legacy confirms neoadjuvant or standalone treatment in HCC8 Dosisphere-01 personalized dosimetry approach improves overall survival7
  • 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 population9

Hear From Y-90 Leaders

Key opinion leaders discuss the impact in treating cancer* patient with TheraSphere and practicing in a multiple disciplinary setting.

Dr Kim-Functioning in a Multi-Disciplinary Team.
Edward Kim, MD FSIR, Associate Professor of Radiology and Surgery, Director of Interventional Oncology with Mount Sinai Health Systems shares his experience with TheraSphere and its ability to help his multi-disciplinary teams treat patients with HCC.
Exceeding the Standards of Care video.
Riad Salem, MD an Interventional Radiologist at Northwestern Memorial Hospital cares about results and treatment tolerability in his patients. “We studied Y-90 in HCC patients at all stages of the disease and we found that it was either equal to or better than the current standards of care but providing a much more gentle treatment for patients. And that was enough to seal the deal.”

TARGET Study Confirms The Significance of Tumor Absorbed Dose on Tumor Response and Overall Survival

Hear from Professor Marnix Lam and Dr. Riad Salem, two of the global PIs, as they discuss the trial design, outcomes, and implications to Y-90 treatment practices.

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Key Clinical Data Show How Different Treatment Approaches Can Improve Survival Outcomes

Every patient is unique and presents their HCC differently. TheraSphere is a versatile, evidence-based HCC therapy with proven clinical results of breakthrough outcomes.

Bridging & Downstaging to Surgery bar.
Bridging & Downstaging to Surgery10 ›
Radiation Segmentectomy bar.
Radiation Segmentectomy11 ›
Radiation Lobectomy bar.
Radiation Lobectomy12
LOBAR + PVT bar.
Lobar + Multi-Compartmental Dosimetry13 ›
global-points-image.

Institutional Decision to Adopt Y-90 as a Primary Treatment for HCC Informed by a 1000-Patient 15-Year Experience

15 year, 1,000 patient cohort treated with TheraSphere showed benefit vs. standard of care.*14

 

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  1. Salem R, Lewandowski R, Roberts C et al. J Vasc Interv Radiol. 2004; 15(4) 335-45
  2. Kulik LM, Atassi B, van Holsbeeck L et al. J Surg Oncol. 2006;94: 572-586
  3. Gaba RC, Lewandowski RJ, Kulik LM et al. Ann Surg Oncol. 2009 Jun;16(6):1587-96
  4. Riaz A, Gates VL, Atassi B et al. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71
  5. Vouche M, Habib A, Ward TJ et al. Hepatology. 2014;60(1):192-201
  6. Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiology. 2018;287(3) epub
  7. Garin et al, J Clin Oncol 38, 2020 (suppl 4; abstr 516)
  8. 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.
  9. Lam, Marnix. A Global Study of Advanced Dosimetry in the Treatment of Hepatocellular Carcinoma with Yttrium-90 Glass Microspheres: Analyses from the TARGET Study. Presented at SIR. March 25, 2021.
  10. Gabr, A., Kulik, L., Mouli, S., Riaz, A., Ali, R., Desai, K., Mora, R.A., Ganger, D., Maddur, H., Flamm, S., Boike, J., Moore, C., Thornburg, B., Alasadi, A., Baker, T., Borja‐Cacho, D., Katariya, N., Ladner, D.P., Caicedo, J.C., Lewandowski, R.J. and Salem, R. (2020), Liver Transplantation Following Yttrium‐90 Radioembolization: 15‐year Experience in 207‐Patient Cohort. Hepatology. Accepted Author Manuscript. doi:10.1002/hep.31318 >=30% hepatic reserve
  11. Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiation segmentectomy: potential curative therapy for early hepatocellular carcinoma. Radiology. 2018; 287(3): 1050-1058.
  12. Gaba RC et al. Ann Surg Oncol 2009;16:1587–96
  13. 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
  14. Salem R, Gabr A, Riaz A, et al. Institutional decision to adopt Y90 as primary treatment for HCC informed by a 1,000-patient 15-year experience. Hepatology. 2017 Dec 1.

*Refers to HCC or associated tumors
**Utilized personalized dosimetry method with >205 Gy to the index lesion while distributing ≤120 Gy to normal liver

 
TheraSphere Indications, Safety, and Warnings
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