Radiation Lobectomy.
Logo

LEGACY Study

Cancer Therapies & Ablation / TheraSphere / Proven Results / LEGACY Study
Legacy

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


Included 162 consecutive treated patients with HCC | Presented by Riad Salem, MD at CIRSE 2020
 Dr Salem comment on LEGACY Study.

 

 

 

 

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

Patients in the LEGACY study responded to TheraSphere treatment(s)
Overall Survival rate in patients with transplant or resection following TheraSphere at 3 years
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.

Tumor Response

Tumor Response

(Best Response in evaluable population, localized mRECIST)
88% 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 Eligibilty 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.


 
Timeline
 

Primary Study Endpoints Were Met

Determined by Blinded Independent Central Review (BICR)

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).

Duration of Response (> 6 months)

Duration of Response (DoR) using localized mRecist.

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

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.
 
HCC: hepatocellular carcinoma; BCLC: Barcelona Clinic Liver Cancer staging system; Y-90: Yttrium-90; Gy: Gray; IQR: Interquartile Range
*University of Washington, Seattle, WA; Northwestern University, Chicago, IL; Mount Sinai Health System, New York, NY
1. Complete Response (CR) and Partial Response (PR) within the treatment area according to localized mRECIST
2. Duration of Response (DoR) According to localized mRECIST
3. Median follow-up was 29.9 months [95% CI: 24.7, 34.6]
 
 

 

PI-869706-AA

Top