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Study of KRAS new predictive marker in a clinical laboratory
- Source :
- Clinical and Translational Oncology. 14:937-942
- Publication Year :
- 2012
- Publisher :
- Springer Science and Business Media LLC, 2012.
-
Abstract
- The presence of somatic mutations in the KRAS gene has been identified as a reliable strong negative predictor for the response to targeting the epidermal growth factor receptor (EGFR), in patients with metastatic colorectal cancer and the use of anti-EGFR monoclonal antibodies such as Cetuximab and Panitumumab is now restricted to patients with no detectable KRAS mutations. Between 30 and 40 % of colorectal cancers contain a mutated KRAS oncogene. The aim of this study was to evaluate concordance between three methods to analyze KRAS mutational status in regard to clinical testing. We analyzed KRAS mutations in codons 12 and 13 of exon 2 in one hundred formalin-fixed paraffin-embedded (FFPE) colorectal cancer samples by three different methods: Direct Sequencing and two commercial kits on allele-specific oligonucleotide hybridization (KRAS StripAssay, Vienna Lab.) and Amplification Refractory Mutation System/Scorpions (ARMS/S; TheraScreen KRAS Mutation kit DxS) based on q-PCR. We have found similar frequencies of KRAS mutations by TheraScreen and Strip-Assay (44 and 48 %), with a κ value of 0.90, indicating almost perfect agreement between methods. The frequency by direct sequencing was much lower (26 %) and the κ values were 0.67 (compared to TheraScreen) and 0.57 (compared to Strip-Assay) indicating low sensitivity. On analyzing KRAS mutation in FFPE tumor samples, direct sequencing sensitivity is too low to be used in a clinical setting. Choosing between ARMS/S; TheraScreen KRAS Mutation kit DxS and KRAS StripAssay, Vienna Lab, will depend on laboratory facilities and expertise.
- Subjects :
- Cancer Research
Colorectal cancer
medicine.disease_cause
Proto-Oncogene Proteins p21(ras)
Exon
Sequence Analysis, Protein
Proto-Oncogene Proteins
Biomarkers, Tumor
medicine
Humans
Panitumumab
Epidermal growth factor receptor
Codon
neoplasms
Genetics
Mutation
Predictive marker
Cetuximab
biology
business.industry
General Medicine
medicine.disease
digestive system diseases
ErbB Receptors
Oncology
ras Proteins
Cancer research
biology.protein
KRAS
Colorectal Neoplasms
business
medicine.drug
Subjects
Details
- ISSN :
- 16993055 and 1699048X
- Volume :
- 14
- Database :
- OpenAIRE
- Journal :
- Clinical and Translational Oncology
- Accession number :
- edsair.doi.dedup.....cd9438ccf95eb9269e638f8105f894c1