Pilot Randomized Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma in Patients Awaiting Transplantation

Tuesday, April 1, 2025

4:12 PM – 4:21 PM CT

Location: Music City Center, 209 ABC

Presenting Author(s)

Rohan Savoor, MD

Resident Physician
University of Pennsylvania, United States

Author/Co-author(s)

SH

Stephen J. Hunt, MD, PhD, FSIR (he/him/his)

Associate Professor
University of Pennsylvania, United States
TG

Terence P.F. P. Gade, MD, PhD

Assistant Professor of Radiology
Department of Radiology, Hospital of the University of Pennsylvania, United States
MD

Mandeep Dagli, MD

Associate Professor of Radiology
Hospital of the University of Pennsylvania, United States
JM

Jeffrey Mondschein, MD

Associate Professor of Clinical Radiology
University of Pennsylvania, United States
WS

William Stavropoulos, MD, FSIR

Professor of Radiology
University of Pennsylvania, United States
Christopher Molvar, MD

Professor of Vascular and Interventional Radiology
Loyola University Medical Center, United States
FM

Faaiza Mahmoud, MD

Professor of Radiology
LUMC, United States
AK

Anusha Kalbasi, MD

Professor of Radiation Oncology
UCLA, United States
TR

Tamer Refaat, MD

Professor of Radiation Oncology
LUMC, United States
TT

Tarita Thomas, MD

Professor of Radiation Oncology
Northwestern University, United States
EB

Edgar Ben-Josef, MD

Professor of Radiation Oncology
University of Pennsylvania, United States
Michael C. Soulen, MD

Professor
Abramson Cancer Center, University of Pennsylvania, United States
Gregory J. Nadolski, MD

MD
Hospital of the University of PA, United States

Purpose: The purpose of this study is to investigate the efficacy of stereotactic body radiotherapy (SBRT) as an adjunct to TACE for local control of HCC prior to transplant (OLT) based on progression free survival (PFS) and pathologic necrosis on explant.

Materials and Methods:

An IRB-approved prospective randomized pilot trial was conducted at two institutions. Adults with HCC listed for OLT were considered for the study. Inclusion criteria included Child-Pugh Class A/B7, ECOG PS 0/1, and planning to receive TACE as bridging locoregional therapy (LRT). Exclusion criteria included prior LRT, refractory ascites, and portal vein thrombosis. Patients were assigned to either TACE-only or TACE + SBRT treatment arms. TACE used lipiodol emulsion (50mg doxorubicin, 10 g mitomycin C ) and 100-300 micron microspheres. SBRT delivered 30-40Gy in 5 fractions of 6-8Gy 4-6 weeks following TACE. Follow up imaging (CT or MRI) occurred 1 month after initial TACE then at 3 month intervals. Primary endpoint was local PFS. Secondary outcomes were overall survival (OS) and pathologic necrosis on explant.

Results:

Forty-two patients were enrolled (median age 62.5 years, 81% male, 38% with solitary HCC, 79% Hepatitis C positive). Median sum of the largest diameter of tumors was 2.8 cm (range 1.1 – 5.3 cm). 35 patients underwent OLT. Median local PFS censored for OLT did not differ (7.4 months TACE-only, 23.7 months TACE + SBRT, p = 0.14). Median OS did not differ (58.1 months TACE-only, 58.8 months TACE + SBRT, p = 0.26). Complete necrosis was on explant was similar (26% TACE-only, 42% TACE + SBRT, p= 0.35). Waitlist time was 11.3 months TACE-only arm vs 9.4 months TACE + SBRT arm. Eight patients dropped out of the waitlist (2 disease progression, 1 medical co-morbidities, 3 patient preference, and 2 expired). No differences in adverse events (AE) were observed between groups. AEs included grade 1 abdominal pain and fatigue (n=13, 30% and n=11, 26% respectively), grade 3 abdominal pain, transaminitis, and diarrhea (n=1 each, 2%), and grade 4 hepatic necrosis related to TACE (n=1, 2%).

Conclusion: This pilot trial demonstrated the addition of SBRT as an adjunct to TACE as a bridging LRT for OLT is safe, but did not significantly increase PFS, OS or histologic complete necrosis rates in a population with largely solitary small tumors. Further studies may be warranted to investigate differences in pathological necrosis with combined therapy.