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

Author(s): Asnacios A, Fartoux L, Romano O, Tesmoingt C, Louafi S S, Mansoubakht T, Artru P, Poynard T, Rosmorduc O, Hebbar M, Taieb J

Affiliation(s): Department of Hepato-gastro-enterology, Pitie Salpetriere Hospital, Paris, France.

Publication date & source: 2008-06-15, Cancer., 112(12):2733-9.

Publication type:

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. (c) 2008 American Cancer Society.