title: Phase 2 trial of concurrent bevacizumab and transhepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma.
abstract: BACKGROUND
  Vascular endothelial growth factor is up-regulated in hepatocellular carcinoma (HCC) and is further up-regulated after transhepatic arterial chemoembolization. The authors of this report conducted a phase 2 trial to evaluate the safety and efficacy of bevacizumab combined with chemoembolization in patients with unresectable HCC.
  
  
  METHODS
  Patients who had an Eastern Cooperative Oncology Group performance of status 0 to 2, a Child-Pugh score of A or B, and Barcelona Clinic Liver Cancer stage B or C HCC were eligible. Treatment consisted of bevacizumab every 2 weeks and chemoembolization during the third week of a 6-week cycle for up to 3 cycles over 6 months. The primary endpoints were safety and efficacy.
  
  
  RESULTS
  Twenty-five patients received chemoembolization and bevacizumab. The most common grade 3 and 4 events after the first treatment cycle were leukocytopenia (12%), fatigue (12%), and hyponatremia (12%). Serious toxicities that had a known association with bevacizumab were observed in 4 patients. Thirty-day mortality was 0%. The median time to tumor progression for the targeted lesions was not reached, and overall survival was 10.8 months. The objective response rate was 60% using enhancement response evaluation criteria, and the disease control rate was 100%.
  
  
  CONCLUSIONS
  Concurrent treatment with bevacizumab and chemoembolization was safe in carefully selected patients and demonstrated antitumor activity in patients with unresectable HCC. These results support the further development of bevacizumab combined with chemoembolization as a treatment for unresectable HCC.
authors.affiliation: Department of Radiology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
authors.forename: Manon
authors.initials: M
authors.lastname: Buijs
authors.forename: Diane K
authors.initials: DK
authors.lastname: Reyes
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Pawlik
authors.forename: Amanda L
authors.initials: AL
authors.lastname: Blackford
authors.forename: Riad
authors.initials: R
authors.lastname: Salem
authors.forename: Wells A
authors.initials: WA
authors.lastname: Messersmith
authors.forename: Colin D
authors.initials: CD
authors.lastname: Weekes
authors.forename: Mary
authors.initials: M
authors.lastname: Mulcahy
authors.forename: Ihab R
authors.initials: IR
authors.lastname: Kamel
authors.forename: Jean-Francois H
authors.initials: JF
authors.lastname: Geschwind
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab