RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict which patients will respond to treatment. PURPOSE: This laboratory study is looking at prognostic factors in patients receiving tegafur-uracil for stage II colon cancer that was completely removed by surgery.
OBJECTIVES: * Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil. * Identify predictive factors of chemosensitivity to this regimen in these patients. OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.
Study Type
OBSERVATIONAL
Enrollment
1,111
UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.
Nagoya Ekisaikai Hospital
Nagoya, Aichi-ken, Japan
Ban Buntane Houtokukai Hospital
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Nagoya University School of Medicine
Nagoya, Aichi-ken, Japan
Nagoya Midori Municipal Hospital
Nagoya, Aichi-ken, Japan
Aichi Prefectural Hospital
mRNA levels
mRNA levels of patients are analyzed by the Danenberg tumor profile (DTP) method in the following indicators: thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP), orotate phosphoribosyltransferase (OPRT), folylpolyglutamate synthetase (FPGS) vascular endothelial growth factor (VEGF), and cyclooxygenase-2 (Cox-2) mRNA levels.
Time frame: 9years
Analysis of microsatellite instability (MSI) and chromosomal instability (CIN)
MSI and CIN (i.e., 18q LOH) are analyzed using paraffin embedded samples.
Time frame: At enrollment
Histopathological examination
Tumor budding, category of extent of poor differentiation, Crohn's-like lymphoid reaction, and fibrotic cancer stroma are analyzed using hematoxylin and eosin (H\&E) staining of paraffin embedded samples.
Time frame: At enrollment
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Okazaki, Aichi-ken, Japan
Yamamoto Kumiai General Hospital
Noshiro, Akita, Japan
Hiraka General Hospital
Yokote, Akita, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Teikyo University Chiba Medical Center
Ichihara, Chiba, Japan
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