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




- 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






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
- Salem R, Lewandowski R, Roberts C et al. J Vasc Interv Radiol. 2004; 15(4) 335-45
- Kulik LM, Atassi B, van Holsbeeck L et al. J Surg Oncol. 2006;94: 572-586
- Gaba RC, Lewandowski RJ, Kulik LM et al. Ann Surg Oncol. 2009 Jun;16(6):1587-96
- Riaz A, Gates VL, Atassi B et al. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):163-71
- Vouche M, Habib A, Ward TJ et al. Hepatology. 2014;60(1):192-201
- Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiology. 2018;287(3) epub
- Garin et al, J Clin Oncol 38, 2020 (suppl 4; abstr 516)
- 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.
- 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.
- 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
- Lewandowski RJ, Gabr A, Abouchaleh N et al. Radiation segmentectomy: potential curative therapy for early hepatocellular carcinoma. Radiology. 2018; 287(3): 1050-1058.
- Gaba RC et al. Ann Surg Oncol 2009;16:1587–96
- 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
- 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