Abstract 992P
Background
Neoadjuvant locoregional therapies are key to bridging hepatocellular carcinoma (HCC) patients to transplantation or resection. The primary endpoints of LEGACY were to evaluate local tumor control and duration of response in unresectable HCC following radiation treatment with Y90 glass microspheres as either a neoadjuvant or stand-alone therapy.
Methods
LEGACY is a retrospective, single-arm, multi-center study conducted at 3 US sites. Study patients included all eligible consecutive HCC patients who received treatment with Y90 glass microspheres (TheraSphere®) between January 2014 and December 2017. Patients were Child-Pugh A, ECOG 0 or 1, with solitary tumors (≤8 cm). Primary efficacy endpoints were Objective Response Rate (ORR) and Duration of Response (DoR). ORR was defined as complete response (CR) or partial response (PR) to treatment based upon mRECIST criteria and was confirmed with subsequent imaging. DoR was evaluated in patients who achieved response. Pre- and post- treatment images were evaluated through a blinded, independent, central review process.
Results
A total of 162 eligible patients were included in the study. ORR was 72.2% (117/162; 95% CI = 64.9%, 78.5%). Forty-five (27.8%) patients were deemed unevaluable due to transplant or resection (n=20), lack of confirmatory imaging (n=20), or for other reasons (n=5). Most patients with a confirmed response experienced DoR ≥ 6 months (89/117, 76.1%, 95% CI = 67.6%, 82.9%). Treatment with Y90 glass microspheres demonstrated suitability as neoadjuvant therapy to transplant or resection (n=45) or as solitary treatment (n=50). Median overall survival (OS) for the intent-to-treat population was 57.9 months, with 3-year OS of 86.6% (51 patients at risk). Liver function, including albumin and bilirubin, were maintained throughout the study follow-up for 92.9% (118/127) and 85.3% (110/129) of patients, respectively.
Conclusions
Patients with solitary, unresectable, advanced HCC treated with Y90 glass microspheres had high response rates, clinically meaningful DoR, and comparable OS to existing curative therapy. Radiation treatment with Y90 glass microspheres is an effective means of treating solitary HCC while preserving liver function.
Clinical trial identification
Editorial acknowledgement
Alexandra Greenberg-Worisek, PhD, MPH (Boston Scientific Corporation).
Legal entity responsible for the study
The authors.
Funding
Biocompatibles UK Ltd/Boston Scientific Corporation.
Disclosure
R. Salem: Advisory/Consultancy: Boston Scientific; Advisory/Consultancy: Eisai; Advisory/Consultancy: Genentech; Advisory/Consultancy: Cook; Advisory/Consultancy: BD. G.E. Johnson: Advisory/Consultancy: Boston Scientific; Advisory/Consultancy: Genentech. A. Riaz: Speaker Bureau/Expert testimony, In 2017 and 2018: BTG. V. Bishav: Speaker Bureau/Expert testimony: Boston Scientific. E. Kim: Advisory/Consultancy: Boston Scientific; Advisory/Consultancy: Eisai; Advisory/Consultancy: Bristol Myers Squibb; Advisory/Consultancy: Guerbet; Advisory/Consultancy: Ethicon. S. Padia: Advisory/Consultancy: Boston Scientific; Advisory/Consultancy: Bristol Meyer Squibb; Research grant/Funding (self): Varian.