Comparison of KRAS Genotype: Therascreen Assay vs. LNA-Mediated qPCR Clamping Assay

• Published in: Clinical colorectal cancer Vol. 12; no. 3; pp. 195 - 203.e2
• Main Authors: Chang, Shao-Chun, Denne, Jonathan, Zhao, Luping, Horak, Christine, Green, George, Khambata-Ford, Shirin, Bray, Christopher, Celik, Ilhan, Van Cutsem, Eric, Harbison, Christopher
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2013
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Cetuximab; Colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - genetics; Colorectal Neoplasms - mortality; DNA, Neoplasm - genetics; EGFR inhibitors; Female; Fluorouracil - administration & dosage; Follow-Up Studies; Gastroenterology and Hepatology; Genotype; Hematology, Oncology and Palliative Medicine; Humans; KRAS; Leucovorin - administration & dosage; Male; Middle Aged; Mutation - genetics; Mutation assay; Neoplasm Staging; Oligonucleotides; Polymerase Chain Reaction; Prognosis; Proto-Oncogene Proteins - genetics; Proto-Oncogene Proteins p21(ras); ras Proteins - genetics; Retrospective Studies; Survival Rate; Young Adult; KRAS; EGFR inhibitors; Cetuximab; Mutation assay; Colorectal cancer
• ISSN: 1533-0028; 1938-0674
• DOI: 10.1016/j.clcc.2013.05.001

Micro-Abstract Kirsten rat sarcoma virus ( KRAS ) wild-type status determined using a locked nucleic acid (LNA)-mediated quantitative polymerase chain reaction (qPCR) clamping assay (LNA assay) predicted response to therapy in the CRYSTAL (Cetuximab Combined With Irinotecan in First-Line Therapy for Metastatic Colorectal Cancer) study in patients with metastatic colorectal cancer (mCRC). The goal of this study was to determine the level of concordance between the LNA assay and a US Food and Drug Administration (FDA)-approved, commercially available KRAS assay (QIAGEN therascreen kit) (QIAGEN Manchester Ltd, Manchester, UK). Using a rigorous retrospective analysis of samples from the CRYSTAL study, a concordance rate of 95% was shown between the therascreen assay and the LNA-mediated qPCR clamping assay. This result confirms the value of KRAS mutation status in patients with mCRC and will allow clinicians to determine which patients are most likely to benefit from cetuximab therapy for first-line therapy in mCRC.