External Quality Assessment Unravels Interlaboratory Differences in Quality of RAS Testing for Anti‐EGFR Therapy in Colorectal Cancer. (5th February 2015)

• Record Type: Journal Article
• Authors: Tack, Véronique; Ligtenberg, Marjolijn J.L.; Tembuyser, Lien; Normanno, Nicola; Vander Borght, Sara; Han van Krieken, J.; Dequeker, Elisabeth M.C.
• Is Part Of: Oncologist. Volume 20:Number 3(2015)
• Page Start: 257
• Page End: 262
• Publication Date: 2015-02-05
• Subjects: Biological markers -- Colorectal neoplasms -- Quality assurance -- Patient safety; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2014-0382
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract : Background: Regulations for the selection of patients with metastatic colorectal cancer for anti‐EGFR treatment changed at the end of 2013. The set of mutations to be tested extended from KRAS codons 12 and 13 to KRAS and NRAS exons 2, 3, and 4. A European external quality assessment scheme monitored the performance of laboratories and evaluated the implementation of the new regulations. Materials and Methods: The 131 participating laboratories received 10 samples of formalin‐fixed paraffin‐embedded material, including RAS ( exon 2, 3, 4 ) and BRAF mutations. Mock clinical data were provided for three cases. Using their routine methods, laboratories determined the genotypes and submitted three written reports. Assessors scored the results according to predefined evaluation criteria. Results: Half of the participants (49.3%) had completely implemented the new test requirements (codons 12, 13, 59, 61, 117, and 146 of KRAS and NRAS ), and 96 laboratories (73.3%) made no genotype mistakes. Correct nomenclature, according to the Human Genome Variation Society, was used by 82 laboratories (62.6%). Conclusion: Although regulations were effective for several months, many laboratories were not ready for full RAS testing in the context of anti‐EGFR therapy. Nevertheless, in each participating country, there are laboratories that provide complete and correct testing. External quality assessments can be used to monitor implementation of new test regulations and to stimulate the laboratories to improve their testing procedures. Because the results of this program are available on the website of the European Society of Pathology, patients and clinicians can refer test samples to a reliable laboratory. Abstract : Regulations for the selection of patients with metastatic colorectal cancer for anti‐EGFR treatment changed at the end of 2013. A European external quality assessment scheme monitored the performance of laboratories and evaluated the implementation of the new regulations. The findings show great variety in the quality of cancer biomarker testing and should raise awareness about the importance of selecting reliable laboratories for biomarker testing in the context of targeted therapy decisions.