S-Space College of Medicine/School of Medicine (의과대학/대학원) Internal Medicine (내과학전공) Journal Papers (저널논문_내과학전공)
Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer
- Han, S-W; Oh, D-Y; Im, S-A; Park, S R; Lee, K-W; Song, H S; Lee, N-S; Lee, K H; Choi, I S; Lee, M H; Kim, M A; Kim, W H; Bang, Y-J; Kim, T-Y
- Issue Date
- Nature Publishing Group
- Br J Cancer. 2009 Jan 27;100(2):298-304. Epub 2009 Jan 6.
- Adult; Aged; Antibodies, Monoclonal/administration & dosage; Antineoplastic Combined Chemotherapy Protocols/*therapeutic use; Female; Fluorouracil/administration & dosage; Humans; Leucovorin/administration & dosage; Liver Neoplasms/chemistry/*drug therapy/secondary; Male; Middle Aged; Neoplasm Recurrence, Local/diagnosis/drug therapy; Neoplasm Staging; Organoplatinum Compounds/administration & dosage; Peritoneal Neoplasms/chemistry/*drug therapy/secondary; Prognosis; Prospective Studies; Stomach Neoplasms/chemistry/*drug therapy/pathology; Survival Rate; Treatment Outcome; Tumor Markers, Biological/*analysis
- 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-alpha 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.
- 1532-1827 (Electronic)
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