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Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC)
Results of a phase II study
Article first published online: 1 MAR 2007
Copyright © 2007 American Cancer Society
Volume 109, Issue 7, pages 1384–1390, April 2007
How to Cite
Louafi, S., Boige, V., Ducreux, M., Bonyhay, L., Mansourbakht, T., de Baere, T., Asnacios, A., Hannoun, L., Poynard, T. and Taïeb, J. (2007), Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC). Cancer, 109: 1384–1390. doi: 10.1002/cncr.22532
- Issue published online: 19 MAR 2007
- Article first published online: 1 MAR 2007
- Manuscript Accepted: 15 DEC 2006
- Manuscript Revised: 4 DEC 2006
- Manuscript Received: 20 OCT 2006
- hepatocellular carcinoma;
- systemic chemotherapy;
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.
Thirty-four patients with previously untreated advanced-stage HCC were prospectively enrolled. The GEMOX regimen consisted of gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity.
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.
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. Cancer 2007. © 2007 American Cancer Society.