Yttrium-90 radioembolization for intermediate-advanced hepatocellular carcinoma: a phase 2 study

Area of Science:

• Hepatobiliary Oncology
• Interventional Radiology
• Radiation Oncology

Background:

• Hepatocellular carcinoma (HCC) is a leading cause of cancer death worldwide.
• Novel therapeutic strategies are needed for intermediate to advanced HCC, particularly those involving portal vein thrombosis (PVT).
• Yttrium-90 radioembolization (Y90RE) is an emerging treatment modality for liver malignancies.

Purpose of the Study:

• To prospectively evaluate the efficacy of Yttrium-90 radioembolization (Y90RE) as a primary treatment for intermediate to advanced hepatocellular carcinoma (HCC).
• To assess time-to-progression (TTP), tumor response, safety, and overall survival (OS) as secondary endpoints.
• To explore the correlation between radiation dose and treatment response in HCC patients.

Main Methods:

• A prospective Phase 2 study involving 52 patients with intermediate (n=17) to advanced (n=35) HCC.
• Y90RE treatment delivered a lobar dose of 120 Gy, with retrospective dosimetric analysis.
• Patients had ECOG scores of 0-1 and Child-Pugh class A-B7; follow-up was 36 months.

Main Results:

• Median TTP was 11 months, and median OS was 15 months, with no significant difference based on PVT status.
• Objective response rate was 40.4%, and disease control rate was 78.8%, significantly impacting survival.
• Tumor response strongly correlated with absorbed dose (r=0.60), with a 500 Gy threshold predicting response (AUC=0.78).
• 30-90 day mortality was 0-3.8%; 36.5% experienced liver function reduction within 6 months.

Conclusions:

• Yttrium-90 radioembolization (Y90RE) is an effective treatment for intermediate to advanced HCC, demonstrating significant survival benefits.
• The treatment shows particular efficacy in patients with portal vein thrombosis (PVT).
• Further comparative studies of Y90RE against conventional therapies are warranted to establish its role in HCC management.