Abstract
Evidence strongly indicates that extended RAS testing should be undertaken in mCRC patients, prior to prescribing anti-EGFR therapies. With more laboratories implementing testing, the requirement for External Quality Assurance schemes increases, thus ensuring high standards of molecular analysis. Data was analysed from 15 United Kingdom National External Quality Assessment Service (UK NEQAS) for Molecular Genetics Colorectal cancer external quality assurance (EQA) schemes, delivered between 2009 and 2016. Laboratories were provided annually with nine colorectal tumour samples for genotyping. Information on methodology and extent of testing coverage was requested, and scores given for genotyping, interpretation and clerical accuracy. There has been a sixfold increase in laboratory participation (18 in 2009 to 108 in 2016). For RAS genotyping, fewer laboratories now use Roche cobas®, pyrosequencing and Sanger sequencing, with more moving to next generation sequencing (NGS). NGS is the most commonly employed technology for BRAF and PIK3CA mutation screening. KRAS genotyping errors were seen in ≤10% laboratories, until the 2014–2015 scheme, when there was an increase to 16.7%, corresponding to a large increase in scheme participants. NRAS genotyping errors peaked at 25.6% in the first 2015–2016 scheme but subsequently dropped to below 5%. Interpretation and clerical accuracy scores have been consistently good throughout. Within this EQA scheme, we have observed that the quality of molecular analysis for colorectal cancer has continued to improve, despite changes in the required targets, the volume of testing and the technologies employed. It is reassuring to know that laboratories clearly recognise the importance of participating in EQA schemes.
Highlights
Precision medicine is very much a key element in clinical oncology
One example can be found in relation to colorectal cancer (CRC), where over recent years, it has become a requirement that patients with mCRC undergo RAS mutation screening, prior to being offered anti-EGFR therapies, as it has been shown that patients with wildtype (WT) RAS may gain benefit from such treatments [3, 5, 11, 14, 19], whereas those with mutated RAS may experience detrimental effects
We report here on the data collected from all 15 of the UK NEQAS colorectal external quality assurance (EQA) schemes, from the first scheme in 2009, with 18 participants, to the most recent 2015–2016 scheme with 108 participating laboratories from both the UK and worldwide
Summary
Precision medicine is very much a key element in clinical oncology. The identification of several biomarkers along with the advent of targeted therapies has changed the landscape of cancer treatment. One example can be found in relation to colorectal cancer (CRC), where over recent years, it has become a requirement that patients with mCRC undergo RAS mutation screening, prior to being offered anti-EGFR therapies, as it has been shown that patients with wildtype (WT) RAS may gain benefit from such treatments [3, 5, 11, 14, 19], whereas those with mutated RAS may experience detrimental effects Laboratories providing such molecular biomarker testing in routine practice must ensure that this work is carried out to the highest possible standards, and this should be monitored and assessed as part of a national or international external quality assurance (EQA) scheme, where possible. The results obtained in the laboratory have direct implications upon patient treatment and as such must be accurate and Virchows Arch (2017) 471:721–729 reproducible to provide the best patient management and avoid over-treating or denying therapy to patients
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