title: Gemcitabine and docetaxel for hepatocellular carcinoma: a phase II North Central Cancer Treatment Group clinical trial.
abstract: OBJECTIVE
  Few effective options are available for the treatment of unresectable hepatocellular carcinoma (HCC). Several phase I trials suggest promising activity of a combination of gemcitabine and docetaxel.
  
  
  METHODS
  Patients with unresectable or metastatic HCC were treated with docetaxel 40 mg/m (later reduced to 30 mg/m) and gemcitabine 800 mg/m on days 1 and 8 every 3 weeks. Twenty-five patients were enrolled in 26 months. Median age was 64 (range, 27-078), 17 were male, 14 had liver-only disease, and 11 had extrahepatic disease.
  
  
  RESULTS
  Of 25 patients evaluable for the primary end point (response), 2 (8%) have a confirmed partial response. The median time to progression is 2.76 months (95% confidence interval, 1.84-6.64 mo). Median survival was 12.8 months (95% confidence interval, 5.26-28.00). Two patients died on study owing to adverse events (1 hepatic and 1 renal failure), neither of which were attributed to the study medications. Twenty patients (81%) have experienced grade 3+ adverse events, including 11 with grade 4+ adverse events, primarily neutropenia, thrombocytopenia, diarrhea, and fatigue.
  
  
  CONCLUSIONS
  Although this combination seems to have potential benefit, as measured by overall survival, its toxicity and the recent introduction of sorafenib has further limited the use of chemotherapy. Approaches other than chemotherapy are likely to be of the greatest potential benefit.
authors.affiliation: Mayo Clinic Rochester, Rochester, MN 55905, USA. alberts.steven@mayo.edu
authors.forename: Steven R
authors.initials: SR
authors.lastname: Alberts
authors.forename: Joel M
authors.initials: JM
authors.lastname: Reid
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Morlan
authors.forename: Gist H
authors.initials: GH
authors.lastname: Farr
authors.forename: John K
authors.initials: JK
authors.lastname: Camoriano
authors.forename: David B
authors.initials: DB
authors.lastname: Johnson
authors.forename: James R
authors.initials: JR
authors.lastname: Enger
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Seay
authors.forename: George P
authors.initials: GP
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D014018:Tissue Distribution; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine