Gemcitabine plus oxaliplatin (GEMOX) combined with cetuximab in patients with progressive advanced stage hepatocellular carcinoma: results of a multicenter phase 2 study.

Abstract

BACKGROUND:

The authors conducted a phase 2 trial of the antiepidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in combination with the gemcitabine plus oxaliplatin (GEMOX) regimen in patients with documented progressive hepatocellular carcinoma (HCC).

METHODS:

Forty-five untreated patients with advanced-stage progressive HCC were prospectively enrolled. Treatment consisted of cetuximab at a dose of 400 mg/m2 initially then 250 mg/m2 weekly, plus gemcitabine at a dose of 1000 mg/m2 on Day 1 and oxaliplatin at a dose of 100 mg/m2 on Day 2, every 2 weeks. Treatment was continued until disease progression, unacceptable toxicity, or patient refusal.

RESULTS:

Overall, 306 cycles were administered. Grade 3 to 4 hematologic toxicity consisted of thrombocytopenia (24%), neutropenia (20%), and anemia (4%). Grade 3 oxaliplatin-induced neurotoxicity occurred in 5 patients (11%) and grade 3 cutaneous toxicity in 7 patients (16%). There were no treatment-related deaths. The confirmed response rate was 20% and disease stabilization was obtained in 40% of patients. The median progression-free and overall survival times were 4.7 months and 9.5 months, respectively. The 1-year survival rate was 40%.

CONCLUSIONS:

In poor-prognosis patients with progressive advanced-stage HCC, the GEMOX-cetuximab combination appears to be active and to have manageable toxicity. A comparative randomized trial is now being planned.

• Authors: Amani Asnacios, Laetitia Fartoux, Olivier Romano, Chloe Tesmoingt, Samy Louafi S, Touraj Mansoubakht, Pascal Artru, Thierry Poynard, Olivier Rosmorduc, Mohamed Hebbar, Julien Taieb
• Journal: Cancer (Cancer) Vol. 112 Issue 12 Pg. 2733-9 (Jun 15 2008) ISSN: 0008-543X [Print] United States
• PMID: 18412149 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2008 American Cancer Society.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Cetuximab
• Gemcitabine

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Hepatocellular (drug therapy)
• Cetuximab
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease Progression
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Liver Neoplasms (drug therapy)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin
• Gemcitabine