Objective: To gain an understanding of current attitudes among oncologists and pathologists to prospective HER2 testing in breast cancer and to gauge whether a national consensus exists regarding extent and quality of testing.
Design: Qualitative study, with semi-quantitative components, using emailed questionnaires and open-ended discussion documents.
Participants: 186 relevant specialists, including 76 breast oncologists and 99 pathologists, representing all but three of the UK cancer networks.
Results: A strong consensus was seen in favour of universal, non-selective testing for HER2 at the point of breast cancer diagnosis. Similarly, an overwhelming majority of participants agreed that, to optimise the quality of test results, all laboratories undertaking HER2 testing should be CPA-accredited, participate in the recognised national external quality assessment scheme (UK NEQAS), and carry out a formal annual audit of its testing service. A further recommendation that testing be restricted to laboratories undertaking a minimum 250 tests per annum for immunohistochemistry and 100 tests per annum for in situ hybridisation techniques met with majority support. However, this was not a clear consensus; a significant minority of participants favoured continued use of local services falling short of these criteria.
Conclusion: This study was successful in gauging national specialist opinion regarding the extent and quality assurance of HER2 testing in the UK.
- DH, Department of Health
- FISH, in situ hybridisation
- IHC, immunohistochemistry
- NEQAS, national external quality assessment scheme
- NICE, National Institute for Health and Clinical Excellence
- HER2 testing
- in situ hybridisation
- quality assurance
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Published Online First 23 February 2007
Funding: The research programme described was funded unconditionally by Roche Products Ltd. The authors acted entirely independently from the funding organisation, which sought no control whatever over the design or content of the research.
Competing interests: None of the authors has any competing financial interests. All authors have received fees for consultation, speaking at symposia and cover for travel from various companies, including Roche Products Ltd. MD has received research funding from various pharmaceutical companies, including Roche Products Ltd