LEGACY study overview
The LEGACY study is a robust multicentre study confirming TheraSphere as a neoadjuvant or standalone therapy in treating HCC1.
It included 162 consecutive treated patients with HCC. Presented by Riad Saleem, MD at CIRCE 2020.
Study objective
To assess local tumour 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
Tumour response
(Best response in evaluable population, localised mRECIST)
88% demonstrated rate of best response by TheraSphere (i.e. CR, PR) by localised mRECIST.
Study design
Multicentre, 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 localised tumour control (mRECIST)
- Reported a median dose to perfused liver volume of 410 Gy
- Demonstrated 100% of patients achieved CR or PR (localised 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 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 localised mRECIST.**
Safety: Majority of adverse events were mild and resolved without medical intervention.
Conclusion
LEGACY is the first multicentre 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 tumour 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]..
- 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.
- 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.
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