TheraSphere™ Y-90 Glass Microspheres

Bridging and Downstaging to Surgery

Hepatology: liver transplantation following Y-90 for HCC overview

15-year, 207 patient experience highlights TheraSphere as an effective treatment for bridging or downstaging HCC to liver transplant therapy with a median overall survival* of 12.5 years.

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*Post transplant

Liver transplantation following yttrium-90 radioembolization: 15-year experience in 207-patient cohort - Ahmed Gabr, Laura Kulik, Samdeep Mouli, Ahsun Riaz, Rehan Ali, Kush Desai, RonaldA Mora, Daniel Ganger, Haripriya Maddur, Steven Flamm, Justin Boike, Christopher Moore, Bartley Thornburg, Ali Alasadi, Talia Baker, Daniel Borja-Cacho, Nitin Katariya, Daniela P Ladner, Juan Carlos Caicedo, Robert J Lewandowski, Riad Salem

Methods: A multidisciplinary team comprised of hepatology, oncology, transplant surgery, and interventional radiology retrospectively reviewed data from 207 patients with unresectable HCC who underwent liver transplant after being treated with Y-90 as part of a bridging or downstaging care pathway.

Results: Of the 207 patients included in these analyses, 38 (19%) patients were downstaged to within Milan transplant criteria and 169 (82%) bridged to transplant with TheraSphere either using lobar (18%, median dose of 124 Gy [IQR: 132-146]) or radiation segmentectomy (82%, median dose 260Gy [IQR: 235-350]) administration.

169 patients were bridged and 38 patients were downstaged to T2 for liver transplant

Median time to LT was 7.5 months

Tumor characteristics at Y-90 and transplant

Percentage of patients compared to baseline characteristics at Y-90 and baseline characteristics at transplantation.

Changes from baseline AFP post Y-90

Median percent decrease of baseline alpha-fetoproteins greater than 100 ng/dl (n=45), 93%, and 13 ng/dl (n=93), 77%.

Median overall survival after liver transplant was 12.5 years

Survival probability post transplant

Survivability chart, with 84% at 3 years, 77% at 5 years, and 60% at 10 years.

74% of patients showed complete or extensive tumor necrosis

on histopathology with an average 10 year recurrence-free survival following liver transplant

Histopathology and recurrence rate post-TheraSphere

Chart with number of patients and degree of tumor explant necrosis including complete, extensive and partial, for original lesion and recurrence.

Survival and recurrence outcomes (N=207)

Overall survival from Y-90 and LT, recurrence-free survival from LT, disease-specific mortality rate, time-to-recurrence, overall survival <65 years and <65 years P=0.003.

Abbreviations

Baseline characteristics at Y-90

Chart showing ages 60 (56-65) and ECOG, Child-Pugh, BCLC, UNOS TNM, AFP (ng/dL), Prior Liver Therapy, Listing, Y-90 Administration, Y-90 Dose (Gy).

Baseline characteristics at liver transplant

Chart showing age 62 (57-66), Meld-Na Score, Wait-list Time (months), Time from Y-90 (months) and Etiology of HC, AFP (ng/dL), Liver Parenchyma, Tumor Grade, Tumor Necrosis.

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

Conclusions

Three, five and ten-year Overall Survival (OS) rates were 84%, 77%, and 60% respectively. 94 (45%), 60 (29%) and 53 (26%) of patients showed complete (no viable tumor), extensive (50-99% necrosis) and partial tumor necrosis (<50% necrosis) on histopathology of which 2%, 7% and 34% had recurrence in each group, respectively. There was a trend towards better OS for patients achieving complete/extensive tumor necrosis (p=0.056). Median recurrence free survival (RFS) post transplant was 120 Months (95%CI: 69-150). There was no differences in OS or RFS for bridged versus downstaged patients.

TheraSphere indications, safety, and warnings

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.