The LEGACY Study
2022 BCLC Staging System Updates1 for HCC Liver Cancer
Updated BCLC guidelines for HCC now include Transarterial Radioembolization (TARE/Y-90) for very early stage (0) and early stage (A) patients.1 These guidelines influence clinical decision making and are based on the LEGACY Study results.2
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The LEGACY study is a robust multicenter study confirming TheraSphere as a neoadjuvant or standalone therapy in treating HCC.2
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
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Overall Survival(Treated population)93% overall survival rate in patients with transplant or resection following TheraSphere at 3 years. |
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Tumor Response(Best Response in evaluable population, localized mRECIST) |
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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.
Primary Study Endpoints Were MetDetermined by Blinded Independent Central Review (BICR) |
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| Safety: Majority of adverse events were mild and resolved without medical intervention. |
LEGACY STUDY 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.
IOL Radio Podcast
The LEGACY Study 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. 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..
2. 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.
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