title: Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study.
abstract: BACKGROUND
  New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma (HCC). In a Phase II trial involving previously untreated patients with advanced HCC, the more favorable schedule from a previous pilot study was evaluated.
  
  
  METHODS
  Thirty-four patients with previously untreated advanced-stage HCC were prospectively enrolled. The GEMOX regimen consisted of gemcitabine 1000 mg/m(2) on Day 1 and oxaliplatin 100 mg/m(2) on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity.
  
  
  RESULTS
  Thirty-two patients were assessable for efficacy and 33 for toxicity. In all, 323 treatment cycles were administered. No toxic deaths occurred. Hematological grade 3-4 toxicity consisted of thrombocytopenia (27% of patients) and neutropenia (24%), including 2 febrile neutropenia and anemia (9%). Grade 3 oxaliplatin-induced neurotoxicity was observed in 3 (9%) patients. The overall response rate was 18% (95% confidence interval [CI]: 8-34) and disease stabilization was observed in 58% of patients (including 5 minor responses), giving a disease control rate of 76%. Median progression-free and overall survival times were, respectively, 6.3 months (95% CI: 4.3-10.1 months) and 11.5 months (95% CI: 8.5-14.3 months). Treatment was significantly more effective in patients with nonalcoholic cirrhosis than in those with alcoholic cirrhosis.
  
  
  CONCLUSIONS
  The GEMOX regimen seems to be well tolerated and active in advanced HCC, especially in patients with underlying nonalcoholic liver disease. A Phase II study of the GEMOX regimen plus cetuximab is ongoing.
authors.affiliation: Service d'Hepato-gastro-enterologie, Groupe Hospitalier Pitie Salpetriere, Paris, France.
authors.forename: Samy
authors.initials: S
authors.lastname: Louafi
authors.forename: Valérie
authors.initials: V
authors.lastname: Boige
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
authors.forename: Luminita
authors.initials: L
authors.lastname: Bonyhay
authors.forename: Touraj
authors.initials: T
authors.lastname: Mansourbakht
authors.forename: Thierry
authors.initials: T
authors.lastname: de Baere
authors.forename: Amani
authors.initials: A
authors.lastname: Asnacios
authors.forename: Laurent
authors.initials: L
authors.lastname: Hannoun
authors.forename: Thierry
authors.initials: T
authors.lastname: Poynard
authors.forename: Julien
authors.initials: J
authors.lastname: Taïeb
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine