Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer

S-W HanD-Y OhS-A ImSR ParkK-W LeeHS SongN-S LeeKH LeeIS ChoiMH LeeMA KimWH KimY-J BangT-Y Kim
Dept. of Internal Medicine (내과학)
Issue Date
British Journal of Cancer, Vol.100(2) : 298-304, 2009
This prospective study was conducted with the Korean Cancer Study Group to evaluate the efficacy and safety of cetuximab combined with modified FOLFOX6 (mFOLFOX6) as first-line treatment in recurrent or metastatic gastric cancer and to identify potential predictive biomarkers. Patients received cetuximab 400 mg m-2 at week 1 and 250 mg m-2 weekly thereafter until disease progression. Oxaliplatin (100 mg m-2) and leucovorin (100 mg m-2) were administered as a 2-h infusion followed by a 46-h continuous infusion of 5-fluorouracil (2400 mg m-2) every 2 weeks for a maximum of 12 cycles. Biomarkers potentially associated with efficacy were analysed. Among 38 evaluable patients, confirmed response rate (RR) was 50.0% (95% CI 34.1–65.9). Median time-to-progression (TTP) was 5.5 months (95% CI 4.5–6.5) and overall survival (OS) 9.9 months. Eleven patients having tumour EGFR expression by immunohistochemistry with low serum EGF and TGF-α levels showed a 100% RR compared to 37.0% in the remaining 27 patients (P<0.001). Moreover, ligand level increased when disease progressed in seven out of eight patients with EGFR expression and low baseline ligand level. No patient exhibited EGFR amplification or K-ras mutations. Gastric cancer patients with EGFR expression and low ligand levels had better outcomes with cetuximab/mFOLFOX6 treatment. Keywords: Cetuximab; chemotherapy; epidermal growth factor; epidermal growth factor receptor; gastric cancer; transforming growth factor-α
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