title: Treating primary liver cancer with hepatic arterial infusion of floxuridine and dexamethasone: does the addition of systemic bevacizumab improve results?
abstract: OBJECTIVE
  This study investigated the efficacy and safety of adding systemic (IV) bevacizumab (Bev) to hepatic arterial infusion (HAI) with floxuridine (FUDR)/dexamethasone (Dex) in unresectable primary liver cancer.
  
  
  METHODS
  Patients with unresectable intrahepatic cholangiocarcinoma (ICC) or hepatocellular carcinoma (HCC) were treated with HAI FUDR/Dex plus IV Bev. Results were compared to a recent study of HAI without Bev in a similar patient population.
  
  
  RESULTS
  Twenty-two patients (18 ICC, 4 HCC) were treated with HAI FUDR/Dex plus Bev; 7 (31.8%) had partial response and 15 (68.2%) had stable disease. Median survival was 31.1 months (CI 14.14-33.59), progression-free survival (PFS) 8.45 months (CI 5.53-11.05), and hepatic PFS 11.3 months (CI 7.93-15.69). In the previous trial with HAI alone (no Bev), the response was 50%; median survival, PFS, and hepatic PFS were 29.5, 7.3, and 10.1 months. In the present trial, bilirubin elevation (>2 mg/dl) was seen in 24% of patients and biliary stents were placed in 13.6%, versus 5.8 and 0%, respectively, in the HAI trial without Bev. Due to increased biliary toxicity, the trial was prematurely terminated.
  
  
  CONCLUSIONS
  Adding Bev to HAI FUDR/Dex appeared to increase biliary toxicity without clear improvement in outcome (median PFS 8.45 vs. 7.3 months, and median survival 31.1 vs. 29.5 months, for HAI + Bev vs. HAI alone groups, respectively).
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. kemenyn @ mskcc.org
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Kemeny
authors.forename: Lawrence
authors.initials: L
authors.lastname: Schwartz
authors.forename: Mithat
authors.initials: M
authors.lastname: Gönen
authors.forename: Adam
authors.initials: A
authors.lastname: Yopp
authors.forename: David
authors.initials: D
authors.lastname: Gultekin
authors.forename: Michael I
authors.initials: MI
authors.lastname: D'Angelica
authors.forename: Yuman
authors.initials: Y
authors.lastname: Fong
authors.forename: Dana
authors.initials: D
authors.lastname: Haviland
authors.forename: Alexandra N
authors.initials: AN
authors.lastname: Gewirtz
authors.forename: Peter
authors.initials: P
authors.lastname: Allen
authors.forename: William R
authors.initials: WR
authors.lastname: Jarnagin
mesh_terms: D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D000068258:Bevacizumab; D001663:Bilirubin / Q000097:blood; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D018281:Cholangiocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005467:Floxuridine; D000068258:Bevacizumab; D003907:Dexamethasone; D001219:Aspartate Aminotransferases; D000469:Alkaline Phosphatase; D001663:Bilirubin