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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
- Authors
- 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
- 2009-01
- Publisher
- NATURE PUBLISHING GROUP
- Citation
- British Journal of Cancer, Vol.100 No.2, pp.298-304
- Keywords
- Cetuximab ; chemotherapy ; epidermal growth factor ; epidermal growth factor receptor ; gastric cancer ; transforming growth factor-alpha
- Abstract
- 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.
- ISSN
- 0007-0920
- Language
- English
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