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The LEGACY study is a robust multicenter study confirming TheraSphere as a neoadjuvant or standalone therapy in treating HCC.1
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
To assess local tumor control and duration of response following treatment with Y-90 glass microspheres in patients with unresectable solitary HCC lesions.
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
(Treated population)
93% overall survival rate in patients with transplant or resection following TheraSphere at 3 years
(Best response in evaluable population, localized mRECIST)
88% demonstrated rate of best response by TheraSphere (i.e. CR, PR) by localized mRECIST.
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.
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.
Determined by Blinded Independent Central Review (BICR)
72.2%
(n=117/162)
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 (DoR) using localized mRECIST.**
Safety: Majority of adverse events were mild and resolved without medical intervention.
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.
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]..
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.
