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Multicenter Study
. 2015 Mar;20(3):257-62.
doi: 10.1634/theoncologist.2014-0382. Epub 2015 Feb 5.

External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer

Véronique Tack  1 , Marjolijn J L Ligtenberg  1 , Lien Tembuyser  1 , Nicola Normanno  1 , Sara Vander Borght  1 , J Han van Krieken  1 , Elisabeth M C Dequeker  2
Affiliations
Multicenter Study

External quality assessment unravels interlaboratory differences in quality of RAS testing for anti-EGFR therapy in colorectal cancer

Véronique Tack et al. Oncologist. 2015 Mar.

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.

Keywords: Biological markers; Colorectal neoplasms; Patient safety; Quality assurance.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1.
Figure 1.
The colon EQA scheme process. Abbreviations: EQA, external quality assessment; HE, hematoxylin and eosin.
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References

    1. Heinemann V, Douillard JY, Ducreux M, et al. Targeted therapy in metastatic colorectal cancer -- an example of personalised medicine in action. Cancer Treat Rev. 2013;39:592–601. - PubMed
    1. Erbitux (cetuximab) [European Public Assessment Report]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_.... Accessed September 25, 2014.
    1. Vectibix (panitumumab) [European Public Assessment Report]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_.... Accessed September 25, 2014.
    1. Douillard JY, Oliner KS, Siena S, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369:1023–1034. - PubMed
    1. Bokemeyer C, Bondarenko I, Hartmann JT, et al. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: The OPUS study. Ann Oncol. 2011;22:1535–1546. - PubMed

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