Phase II trial of docetaxel therapy in patients with advanced hepatocellular carcinoma.
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.
Hebbar
Mohamed
M
Unité d'Oncologie Médicale, Centre Hospitalo-Universitaire, Lille, France. m-hebbar@chru-lille.fr
Ernst
Olivier
O
Cattan
Stéphane
S
Dominguez
Sophie
S
Oprea
Corina
C
Mathurin
Philippe
P
Triboulet
Jean-Pierre
JP
Paris
Jean-Claude
JC
Pruvot
François-René
FR
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
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel