Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis

Abstract

BACKGROUND The safety and efficacy of yttrium 90 (90Y) therapy for unresectable infiltrative hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) requires further evaluation. METHODS A prospective, single-center safety and feasibility study recruited patients with unresectable (Barcelona Clinic Liver Cancer stage C) infiltrative HCC with PVT. Safety was assessed according to Common Terminology Criteria for Adverse Events version 4.0. Overall survival (OS) and time to progression (TTP) were measured from the first 90Y therapy. Survival analysis was performed with Kaplan-Meier estimation. Prognostic factors were tested with a log-rank test and Cox proportional regression analysis. RESULTS Overall, 45 patients were recruited, and 30 patients who met the study's inclusion criteria underwent glass-based 90Y therapy. Four patients (13%) had transient hepatobiliary toxicity (grade ≥ 2). Ten patients (33%) had related emergency department visits, with 5 patients (17%) requiring short-term hospitalization. No radiation pneumonitis, gastrointestinal ulceration, or procedure-related mortality occurred. The median OS was 13 months (95% confidence interval, 4.4-22 months) with a TTP of 9 months (95% confidence interval, 6.2-13.1 months). Absence of ascites, an international normalized ratio < 1.2, an Eastern Cooperative Oncology Group (ECOG) performance status of 0, Child-Pugh class A, a macroaggregated albumin lung shunt fraction (LSF) < 10%, and no hepatobiliary toxicity were significant predictors of prolonged OS according to a univariate analysis (P < .05). A multivariate analysis found an ECOG performance status of 0, Child-Pugh class A, an LSF < 10%, and lack of transient hepatobiliary toxicity (grade ≥ 2) to be independent predictors of prolonged OS (P < .05). An ECOG performance status of 0, Child-Pugh class A, and an LSF < 10% were also predictors of prolonged TTP according to the multivariate analysis (P < .05). CONCLUSIONS In patients with unresectable infiltrative HCC and PVT, 90Y therapy appears to be a safe and viable therapy. Cancer 2015;121:2164-2174.