Nima Kokabi1, Juan C Camacho1,2, Minzhi Xing1,3, Bassel F El-Rayes4, James R Spivey5, Stuart J Knechtle6, Hyun S Kim1,3,4,7. 1. Division of Interventional Radiology and Image Guided Medicine, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia. 2. Division of Abdominal Imaging, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia. 3. Division of Interventional Radiology, Department of Radiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 4. Division of Medical Oncology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. 5. Division of Digestive Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia. 6. Duke Transplant Center, DUMC 3512, Durham, North Carolina. 7. Cancer Therapeutics Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
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, 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, (90) Y therapy appears to be a safe and viable therapy.
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, 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, (90) Y therapy appears to be a safe and viable therapy.
Authors: Young Youn Cho; Minjong Lee; Hyo-Cheol Kim; Jin Wook Chung; Yun Hwan Kim; Geum-Youn Gwak; Si Hyun Bae; Do Young Kim; Jeong Heo; Yoon Jun Kim Journal: PLoS One Date: 2016-05-05 Impact factor: 3.240