title: Phase II trial of docetaxel therapy in patients with advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  We assessed the safety and efficacy of docetaxel, a microtubule inhibitor, in patients with advanced hepatocellular carcinoma (HCC).
  
  
  METHODS
  HCC patients that were not suitable for local therapy, but who possessed measurable disease, good performance status and adequate organ function were eligible. Docetaxel was administered every 3 weeks at a dose of 100 mg/m(2) (or 75 mg/m(2) if transaminase levels were between 1.5 and 3.5 times the upper normal limit). Efficacy was assessed radiologically every three cycles of chemotherapy.
  
  
  RESULTS
  Fifteen patients were enrolled: 11 males and 4 females; their median age was 64 years (range, 42-72 years). Nine patients had underlying cirrhosis. Four patients had been surgically treated before relapse (liver resection in 3 cases and transplantation in 1), 3 had been treated with arterial chemoembolization and 1 with arterial chemotherapy (doxorubicin). A total of 57 cycles of docetaxel were delivered (median 3, range 1-6). Significant toxicity was observed: mostly grade 3-4 neutropenia and fatigue (6 and 4 patients, respectively). Treatment had to be stopped because of toxicity in 6 patients, all having underlying cirrhosis. An important partial response was obtained in 1 patient, a result that enabled liver transplantation; this patient is still alive after 34 months. Five patients had transient stable disease.
  
  
  CONCLUSIONS
  When used in this schedule, docetaxel does not appear to be safe and effective enough in patients with advanced HCC and cirrhosis.
authors.affiliation: Unité d'Oncologie Médicale, Centre Hospitalo-Universitaire, Lille, France. m-hebbar@chru-lille.fr
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hebbar
authors.forename: Olivier
authors.initials: O
authors.lastname: Ernst
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cattan
authors.forename: Sophie
authors.initials: S
authors.lastname: Dominguez
authors.forename: Corina
authors.initials: C
authors.lastname: Oprea
authors.forename: Philippe
authors.initials: P
authors.lastname: Mathurin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Triboulet
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Paris
authors.forename: François-René
authors.initials: FR
authors.lastname: Pruvot
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000556:secondary; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel