title: Gemcitabine plus oxaliplatin (GEMOX) combined with cetuximab in patients with progressive advanced stage hepatocellular carcinoma: results of a multicenter phase 2 study.
abstract: BACKGROUND
  The authors conducted a phase 2 trial of the antiepidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in combination with the gemcitabine plus oxaliplatin (GEMOX) regimen in patients with documented progressive hepatocellular carcinoma (HCC).
  
  
  METHODS
  Forty-five untreated patients with advanced-stage progressive HCC were prospectively enrolled. Treatment consisted of cetuximab at a dose of 400 mg/m2 initially then 250 mg/m2 weekly, plus gemcitabine at a dose of 1000 mg/m2 on Day 1 and oxaliplatin at a dose of 100 mg/m2 on Day 2, every 2 weeks. Treatment was continued until disease progression, unacceptable toxicity, or patient refusal.
  
  
  RESULTS
  Overall, 306 cycles were administered. Grade 3 to 4 hematologic toxicity consisted of thrombocytopenia (24%), neutropenia (20%), and anemia (4%). Grade 3 oxaliplatin-induced neurotoxicity occurred in 5 patients (11%) and grade 3 cutaneous toxicity in 7 patients (16%). There were no treatment-related deaths. The confirmed response rate was 20% and disease stabilization was obtained in 40% of patients. The median progression-free and overall survival times were 4.7 months and 9.5 months, respectively. The 1-year survival rate was 40%.
  
  
  CONCLUSIONS
  In poor-prognosis patients with progressive advanced-stage HCC, the GEMOX-cetuximab combination appears to be active and to have manageable toxicity. A comparative randomized trial is now being planned.
authors.affiliation: Department of Hepato-gastro-enterology, Pitié Salpétrière Hospital, Paris, France.
authors.forename: Amani
authors.initials: A
authors.lastname: Asnacios
authors.forename: Laetitia
authors.initials: L
authors.lastname: Fartoux
authors.forename: Olivier
authors.initials: O
authors.lastname: Romano
authors.forename: Chloe
authors.initials: C
authors.lastname: Tesmoingt
authors.forename: Samy
authors.initials: S
authors.lastname: Louafi S
authors.forename: Touraj
authors.initials: T
authors.lastname: Mansoubakht
authors.forename: Pascal
authors.initials: P
authors.lastname: Artru
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.forename: Olivier
authors.initials: O
authors.lastname: Rosmorduc
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hebbar
authors.forename: Julien
authors.initials: J
authors.lastname: Taieb
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D000068818:Cetuximab; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D000077150:Oxaliplatin; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine