title: Prospective randomized pilot study of Y90+/-sorafenib as bridge to transplantation in hepatocellular carcinoma.
abstract: OBJECTIVE
  To investigate the safety and adverse event profile of sorafenib plus radioembolization (Y90) compared to Y90 alone in patients awaiting liver transplantation.
  
  
  METHODS
  20 patients with HCC were randomized to Y90 alone (Group A) or Y90+sorafenib (Group B). Adverse events, dose reductions, and peri-transplant complications were assessed.
  
  
  RESULTS
  All patients in the sorafenib group necessitated dose reductions. Seventeen of 20 patients underwent liver transplantation; median time-to-transplant was 7.8 months (range: 4.2-20.3) and similar between groups (p = 0.35). In the sorafenib group, there were 4/8 peri-transplant (<30 days) biliary complications (p = 0.029) and 3/8 acute rejections (p = 0.082); there were none in the Y90-only group. Survival rates were 70% (Group A) and 72% (Group B) at 3 years (p = 0.57).
  
  
  CONCLUSIONS
  The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation. Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections. Caution should be exercised when considering sorafenib in the transplant setting. Further investigation is warranted.
authors.affiliation: Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Kulik
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Vouche
authors.affiliation: Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL, USA.
authors.forename: Sean
authors.initials: S
authors.lastname: Koppe
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA; Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lewandowski
authors.affiliation: Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.
authors.forename: Mary F
authors.initials: MF
authors.lastname: Mulcahy
authors.affiliation: Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ganger
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA.
authors.forename: Ali
authors.initials: A
authors.lastname: Habib
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Karp
authors.affiliation: Department of Medicine, Division of Hepatology, Northwestern University, Chicago, IL, USA.
authors.forename: Patrice
authors.initials: P
authors.lastname: Al-Saden
authors.affiliation: Department of Medicine, Division of Dermatology, Memorial Sloan Kettering, New York, NY, USA.
authors.forename: Mario
authors.initials: M
authors.lastname: Lacouture
authors.affiliation: Department of Dermatology, Northwestern University, Chicago, IL, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Cotliar
authors.affiliation: Department of Surgery, Division of Transplant Surgery, Northwestern University, Chicago, IL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Abecassis
authors.affiliation: Department of Surgery, Division of Transplant Surgery, Northwestern University, Chicago, IL, USA.
authors.forename: Talia
authors.initials: T
authors.lastname: Baker
authors.affiliation: Department of Radiology, Section of Interventional Radiology, Northwestern University, Chicago, IL, USA; Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA; Department of Surgery, Division of Transplant Surgery, Northwestern University, Chicago, IL, USA. Electronic address: r-salem@northwestern.edu.
authors.forename: Riad
authors.initials: R
authors.lastname: Salem
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D004621:Embolization, Therapeutic; D005260:Female; D006084:Graft Rejection; D006526:Hepatitis C / Q000188:drug therapy; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D011446:Prospective Studies; D011829:Radiation Dosage; D000077157:Sorafenib; D015021:Yttrium Radioisotopes / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D015021:Yttrium Radioisotopes; D009536:Niacinamide; D000077157:Sorafenib
keywords: Hepatocellular carcinoma; Radioembolization; Sorafenib; Transplantation