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Phase II study of cetuximab in patients with unresectable or metastatic hepatocellular carcinoma.

14096 Background: Patients with advanced hepatocellular carcinoma (HCC) have a poor prognosis with no established systemic treatment regimen. Epidermal growth factor receptor/human epidermal growth factor receptor 1 (EGFR/HER1) and ligand expression is frequently seen in HCC. Recent studies suggest that erlotinib, an EGFR/HER1 tyrosine kinase inhibitor, may have benefit in stabilizing HCC. We performed a phase II study with cetuximab, a chimeric monoclonal antibody that binds selectively to EGFR, in advanced HCC.


METHODS
Eligibility criteria include unresectable or metastatic measurable HCC, up to two prior systemic regimens, performance status ≤ 2, CLIP score ≤ 3, and adequate organ functions. The initial dose of cetuximab is 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Each cycle is defined as 6 consecutive weekly treatments. EGFR expression was assayed by immunohistochemistry and trough serum concentrations of cetuximab were determined during the first cycle. The primary endpoint of the study was progression free survival (PFS).


RESULTS
The planned 30 patients have been enrolled: median age = 58 (33-82), M/F = 23/7, ECOG 0/1/2 = 16/12/2, CLIP 0/1/2/3=2/9/14/5. No responses were seen. Five patients had stable disease. The median number of cycles on study per patient was 1 (range, 1-3). 16 patients developed progressive disease following one cycle of treatment. Only one patient remains on study. The median PFS and OS were 41 days (95% CI, 36 to 79) and 157 days (95% CI, 112 to not available), respectively. The treatment was generally well tolerated. No treatment related deaths occurred. Treatment related grade 1-2 toxicities included rash (83%), fatigue (47%), hypomagnesemia (27%), nausea (20%), anemia (13%), diarrhea (13%), anorexia (13%), and elevation of SGOT/SGPT (10%). Grade 3 SGOT, hypomagnesemia, and fever without neutropenia were seen in one patient (3%) each.


CONCLUSIONS
Cetuximab has no activity in HCC in this phase II study. It can be safely given with tolerable toxicity profiles in HCC patients. Updated information on toxicity, efficacy, EGFR expression and pharmacokinetics will be presented at the meeting. Supported by Bristol-Myers Squibb. [Table: see text].