Gemcitabine, oxaliplatin (GEMOX) and cetuximab for treatment of hepatocellular carcinoma (HCC): Results of the phase II study ERGO

Abstract

4594 Background: A promising efficacy of the GEMOX combination was previously reported in HCC. Moreover, the EGFR signalling pathway is involved in hepatic carcinogenesis and tumor progression. This phase II study of GEMOX plus cetuximab was therefore undertaken in patients with unresectable HCC. Methods: 44 patients were included in the study between November 2005 and October 2006. All patients received cetuximab (initial dose 400 mg/m 2 BSA then 250 mg/m 2 weekly) combined with GEMOX (gemcitabine 1000 mg/m 2 , Day 1 and oxaliplatin 100 mg/m 2 , Day 2), repeated every 14 days until disease progression or limiting toxicity. Inclusion criteria were: histologically proven HCC or morphologically typical hepatic tumor with alpha-feto protein (AFP) level >250 ng/mL, ECOG performance status (PS) 0–2, age =18, measurable lesion, platelets >100.10 9 G/L, PNN >1.5.10 9 G/L, creatinine <120 μmol/L, non decompensated Child A or B cirrhosis, documented tumor progression (RECIST), informed consent. Results: 43 patients, including 22 with baseline AFP >400, were evaluable for safety and 35 for efficacy. Patients’ characteristics, toxicity and efficacy are summarized in the table below; 26% of patients received prior intra-arterial chemotherapy. Only one grade 4 toxicity was reported (thrombocytopenia). Grade 3 toxicities were: thrombocytopenia (21%) neutropenia (19%), acneiform rash (19%), asthenia (7%). Grade 2 and 3 neurotoxicity (specific scale) occurred in 16% and 5% of patients, respectively. No toxic death or other severe toxicity was reported. Conclusion: GEMOX plus cetuximab was well tolerated and induced a satisfactory control of disease in progressive HCC. Final results will be presented at the meeting. [Table: see text] No significant financial relationships to disclose.