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/m^2^ initially then 250 mg/m^2^ weekly, plus gemcitabine at a dose of 1000 mg/m^2^ on Day 1 and oxaliplatin at a dose of 100 mg/m^2^ 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. Cancer 2008. © 2008 American Cancer Society.