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Cancer. 2007 Apr 1;109(7):1384-90.

Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study.

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1
Service d'Hepato-gastro-enterologie, Groupe Hospitalier Pitie Salpetriere, Paris, France.

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.

PMID:
17330837
DOI:
10.1002/cncr.22532
[Indexed for MEDLINE]
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