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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

LEGACY study

LEGACY study overview

The LEGACY study is a robust multicenter study confirming TheraSphere as a neoadjuvant or standalone therapy in treating HCC.1

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Updated BCLC guidelines for HCC now include Transarterial Radioembolization (TARE/Y-90) for very early stage (0) and early stage (A) patients.2 These guidelines influence clinical decision making and are based on the LEGACY Study results.1

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Study objective

To assess local tumor control and duration of response following treatment with Y-90 glass microspheres in patients with unresectable solitary HCC lesions.

Key study results

100%

Patients in the LEGACY study responded to TheraSphere treatment(s)

93%

Overall Survival rate in patients with transplant or resection following TheraSphere at 3 years

88%

Demonstrated rate of best response by TheraSphere

Overall survival

(Treated population)

93% overall survival rate in patients with transplant or resection following TheraSphere at 3 years

Graph showing 93% overall survival rate at 3 years in patients with transplant or resection following TheraSphere.

Tumor response

(Best response in evaluable population, localized mRECIST)

88% demonstrated rate of best response by TheraSphere (i.e. CR, PR) by localized mRECIST.

Graph showing 88% (95% CI: 82.4-92.4 N=162) demonstrated rate of best response by TheraSphere (i.e. CR, PR) by localized mRECIST.

Study design

Multi-center, single-arm, retrospective study conducted at 3 U.S. sites.* Consecutive patients meeting the eligibility criteria were treated with TheraSphere Y-90 Glass Microspheres at each site between January 2014 and December 2017.

First and only

  • Used highly clinically relevant criteria for localized tumor control (mRECIST)
  • Reported a median dose to perfused liver volume of 410 Gy
  • Demonstrated 100% of patients achieved CR or PR (localized mRECIST)

Key eligibility criteria

Unresectable solitary lesions (≤ 8 cm); Selective, lobar, or mixed administration of Y-90 glass microspheres (TheraSphere); Treatment purpose (neoadjuvant to transplantation or resection or stand-alone treatment); Child-Pugh score A; BCLC A or BCLC C (ECOG 1); No prior liver transplantation, resection, locoregional treatment or systemic therapy; No portal vein thrombosis or extrahepatic disease.

Table with key baseline characteristics (N=162), median age: 66 years, with % of patients: >= 75 years, 17.9; BCLC A: 60.5, BCLC C: 39.5; median tumor size: 2.6 cm (0.9-8.1 cm).

Primary study endpoints were met

Determined by Blinded Independent Central Review (BICR)

72.2%

(n=117/162)

Objective responsive rate

Objective Response Rate (ORR) defined as CR or PR using localized mRECIST (defined as the response within the Y-90 glass microsphere treatment area) with confirmation of response (>4 weeks).

76.1%

(n=89/117)

Duration of response (> 6 months)

Duration of Response (DoR) using localized mRECIST.**

Safety: Majority of adverse events were mild and resolved without medical intervention.

Conclusion

LEGACY is the first multicenter study to report a high median perfused volume absorbed dose of 410 Gy with TheraSphere, which resulted in an 88% best response, excellent and durable tumor control and high overall survival rate in patients with early and advanced HCC.

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IOL Radio podcast

Listen in to an IOL Radio podcast discussion about the results of the LEGACY Study, a robust multicenter study confirming Boston Scientific’s TheraSphere™ as a neoadjuvant or standalone therapy in treating hepatocellular carcinoma.

Listen to podcast
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The LEGACY study showcase

This presentation provides background on the use of Y-90 glass microspheres to treat HCC, discusses results of the LEGACY study and recently published studies using Y-90 glass microspheres.

Watch the showcase

HCC: hepatocellular carcinoma; BCLC: Barcelona Clinic Liver Cancer staging system; Y-90: Yttrium-90; Gy: Gray; IQR: Interquartile Range; CR: Complete Response; PR: Partial Response.

* University of Washington, Seattle, WA; Northwestern University, Chicago, IL; Mount Sinai Health System, New York, NY.

** Median follow-up was 29.9 months [95% CI: 24.7, 34.6]..

  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. Reig M, Forner A, Rimola J, et al. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2021;S0168-8278(21)02223-6. doi:10.1016/j.jhep.2021.11.018.

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.