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

Exceeding the standards of care
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.”







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, 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.
- 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