title: 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, 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.affiliation: Division of Interventional Radiology and Image Guided Medicine, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Nima
authors.initials: N
authors.lastname: Kokabi
authors.affiliation: Division of Interventional Radiology and Image Guided Medicine, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia.|Division of Abdominal Imaging, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Camacho
authors.affiliation: Division of Interventional Radiology and Image Guided Medicine, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia.|Division of Interventional Radiology, Department of Radiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
authors.forename: Minzhi
authors.initials: M
authors.lastname: Xing
authors.affiliation: Division of Medical Oncology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Bassel F
authors.initials: BF
authors.lastname: El-Rayes
authors.affiliation: Division of Digestive Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: James R
authors.initials: JR
authors.lastname: Spivey
authors.affiliation: Duke Transplant Center, DUMC 3512, Durham, North Carolina.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Knechtle
authors.affiliation: Division of Interventional Radiology and Image Guided Medicine, Department of Radiology, Emory University School of Medicine, Atlanta, Georgia.|Division of Interventional Radiology, Department of Radiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.|Division of Medical Oncology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.|Cancer Therapeutics Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.
authors.forename: Hyun S
authors.initials: HS
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000473:pathology* / Q000532:radiotherapy / Q000628:therapy*; D018450:Disease Progression; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology* / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011169:Portal Vein / Q000473:pathology; D011379:Prognosis; D011446:Prospective Studies; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000473:pathology* / Q000532:radiotherapy / Q000628:therapy*; D015021:Yttrium Radioisotopes / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D015021:Yttrium Radioisotopes
keywords: efficacy; infiltrative hepatocellular carcinoma (HCC); overall survival; portal vein thrombosis; safety; time to progression; yttrium 90 (90Y) radioembolization