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Internal view of patient's torso demonstrating targeted accuracy of TheraSphere Y-90 Glass Microspheres in liver.

TheraSphere™ Y-90 Glass Microspheres

PREMIERE and TRACE trials

TACE & Y-90: PREMIERE & TRACE trials overview

Comparison of contemporary transarterial radioembolization (TARE) treatment via TheraSphere to drug-eluting bead transarterial chemoembolization (DEB-TACE*) and conventional transarterial chemoembolization (cTACE) in patients with HCC shows longer time to tumor progression as a cost-effective, efficient treatment option.​

Filename
PREMIERE_TRACE_Y-90_comparison_data_sheet.pdf
Size
765 KB
Format
application/pdf
Download Y-90 / DEB-TACE / cTACE data
See TRACE abstract
Filename
TheraSphere_pub_summary_Salem_Gastro.pdf
Size
561 KB
Format
application/pdf
Download Y90 Prolongs TTP vs cTACE: PREMIERE trial data
See PREMIERE full manuscript

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

Glass Y-90 / DEB-TACE / cTACE

Table with Glass Y-90, DEB-TACE, cTACE, with data on Mechanism of Action, Benefits, Challenges, Average Number of Treatments, Embolic Effects, Approved for Unresectable HCC, Future Treatment Options.

A proven clinical and economic treatment option

  • Fewer treatments and less hospitalizations than cTACE13
  • A cost-effective bridging therapy as patients require lower number of LRT sessions prior to liver transplant14

Number of treatments received in patients treated with TACE vs. TheraSphere

Graph with percent of patients treated and number of treatments received, comparing TheraSphere and TACE.

Contemporary randomized-control trials of PREMIERE15 and TRACE16 show improved time to tumor progression when utilizing Glass Y=90 over cTACE and DEB-TACE respectively.

PREMIERE trial

Prospective, randomized, open label, single-center study from 2009-2015 cTACE vs. Glass Y-90 TARE for treatment of unresectable, unablatable HCC.15

Diagram showing Glass Y-90 (n=24) and cTACE (n=21), randomization 1:1, with Primary Endpoint: TTP and Secondary Endpoint: RR, OS, Safety.

Inclusion

  • Image/biopsy confirmed HCC, unablatable/unresectable HCC with no vascular invasion, Child-Pugh A/B, Bilirubin ≤2.0 mg/dl, AST/ALT ≤5x upper limit of normal
  • BCLC A patients not eligible for ablation or resection due to lesion size/location, liver function, multifocal disease, or presence of portal hypertension
  • BCLC B patients were considered eligible for cTACE or Glass Y-90 with the curative intent of liver transplantation

Time to progression

Graph of percent without progression against months since randomization, comparing Y-90 and cTACE, with Y-90 showing higher percent without progression.

>26 mo vs. 6.8 mo; p=0.0012

 

Glass Y-90 treatment showed longer time to tumor progression than cTACE

TRACE trial*

Prospective, randomized, open label, single-center superiority study from 2011-2018 DEB-TACE vs. Glass Y-90 TARE for treatment of unresectable HCC.16

Diagram showing Glass Y-90 (n=38) and DEB-TACE (n=34), randomization 1:1, with Primary Endpoint: TTP and Secondary Endpoint: TTP (whole liver, local), PFS, ORR, OS, Safety.

Inclusion

  • Image/biopsy confirmed, unablatable, unresectable HCC not eligible for transplant
  • BCLC B, extended to BCLC A not amendable to surgery or ablation, Child-Pugh A, ECOG 1

Time to progression

Graph of probability of stable disease in time (months) with events, median (95% CI) and HR (95% CI) for TARE and DEB-TACE.

17.1 mo vs. 9.5 mo; HR: 0.36, p=0.002

 

Glass Y-90 Treatment showed longer time to tumor progression than DEB-TACE

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

Conclusions

  • Contemporary prospective randomized control trials of patients with HCC shows consistently longer time to tumor progression using TheraSphere Y-90 Glass Microspheres than conventional or drug-eluting bead TACE treatments.
  • Unlike TACE, TheraSphere Y-90 Glass Microspheres with the microembolic effect better maintains patient eligibility for future treatment for HCC.
  • Typically with 1 outpatient treatment, requiring fewer treatments than DEB-TACE or cTACE, TheraSphere Y-90 Glass Microspheres is a cost-effective treatment option for patients with HCC.
  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. Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, Ayuso C, Castells L, Montañá X, Llovet JM, Bruix J. Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics. J Hepatol 2007; 46: 474-481 [PMID: 17239480 DOI: 10.1016/j.jhep.2006.10.020].
  3. Wang, Y, et al. Chin J Cancer Res 2015;27(2):96-121.
  4. Song, J,. Et al. World J Hepatol. 2017 Jun 28; 9(18):808-814.
  5. Song MJ, Chun HJ, Song DS, Kim HY, Yoo SH, Park CH, Bae SH, Choi JY, Chang UI, Yang JM, et al. Comparative study between doxorubicin-eluting beads and conventional transarterial chemoembolization for treatment of hepatocellular carcinoma. J Hepatol. 2012;57:1244–1250.
  6. Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, Pitton M, Sergent G, Pfammatter T, Terraz S, et al. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010;33:41–52.
  7. Golfieri R, Giampalma E, Renzulli M, Cioni R, Bargellini I, Bartolozzi C, Breatta AD, Gandini G, Nani R, Gasparini D, et al. Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. Br J Cancer. 2014;111:255–264.
  8. Walrand S, Hesse M, Jamar F, Lhommel R. A hepatic dose-toxicity model opening the way toward individualized radioembolization planning. J Nucl Med. Aug 2014;55(8):1317-1322.
  9. Garin E, Tselikas L, Guiu B, et al. Personalised 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. Jan 2021;6(1):17-29.
  10. Lam MG. A global study of advanced dosimetry in the treatment of hepatocellular carcinoma with Yttrium-90 glass microspheres: analysis from the TARGET study. Paper presented at: SIR; March 25, 2021.
  11. Pasciak AS, Abiola G, Liddell RP, et al. The number of microspheres in Y90 radioembolization directly affects normal tissue radiation exposure. Eur J Nucl Med Mol Imaging. Apr 2020;47(4):816-827.
  12. Walton M, Wade R, Claxton L, et al. Selective internal radiation therapies for unresectable early-, intermediate- or advanced-stage hepatocellular carcinoma: systematic review, network meta-analysis and economic evaluation. Health Technol Assess. Sep 2020;24(48):1-264.
  13. Moreno-Luna LE et al. Cardiovasc Intervent Radiol 2013;36(3):714–23.
  14. Zori et al Am J Gastroenterology 2017; 112 Supplement 1 1035.
  15. Salem R, et al. Gastroenterology. 2016 Dec;151(6):1155-1163.e2. doi: 10.1053/j.gastro.2016.08.029. Epub 2016 Aug 27.
  16. Dhondt, E. et al. Radiology. 2022;000:1-12.
  17. Kim, H. Clin Mol Hepatol. 2017; 23(2):109-114.

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.