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 ( 90 Y) 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 90 Y 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 90 Y 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, ChildPugh class A, and an LSF < 10% were also predictors of prolonged TTP according to the multivariate analysis (P <.05). CONCLU-SIONS: In patients with unresectable infiltrative HCC and PVT, 90 Y therapy appears to be a safe and viable therapy. Cancer 2015;121:2164-74.

Effect of yttrium‐90 radioembolization on outcomes in Asian patients with early to advanced stage hepatocellular carcinoma

“…The burdens of HCC in patients with PD was so extensive (main portal invasion, bi‐lobar distribution) that radioembolization could not achieve adequate tumor control. Although radioembolization has been shown to be safe and effective for unresectable HCC with portal vein invasion, radioembolization may not have been effective in the extensive HCCs evaluated in this study. Therefore, there is a need for further investigation of the optimal HCC candidates for radioembolization, especially among those with stage C.…”

Yttrium-90 radioembolization for advanced inoperable hepatocellular carcinoma

“… 33 , 34 More recently, Kokabi et al demonstrated that Eastern Cooperative Oncology Group performance status of 0, Child–Pugh Class A, and lung shunting fraction <10% were independent prognostic factors of time to progression after radioembolization in patients who had portal vein thrombosis in their HCC. 35 …”

Therapy for inoperable hepatocellular carcinoma with selective transarterial radioembolization with yttrium-90 microspheres

“…В настоящее время в мире применяю микросферы двух типов -резиновые и стеклянные. В исследованиях без сравнения и стеклянные, и резиновые микросферы с иттрием-90 доказали свою безопасность и эффективность, не зависящую при этом от изготовителя [11,12]. В доступной литературе [13] выявлено лишь одно исследование, в котором сравниваются эти два типа сфер в отношении ГЦР.…”