Authors' objectives: The aim of this report is to assess the clinical effectiveness and costeffectiveness of selected gene expression profiling (GEP) and expanded immunohistochemistry (IHC) tests compared to alternative risk assessment methods for early breast cancer patients.

Authors' results and conclusions: RESULTS - Most evidence is available for Oncotype and MammaPrint. For some of these tests, there is good evidence supporting their prognostic ability, but very limited and weak information on their clinical utility. Direct evidence evaluating the effect of GEP or expanded IHC testing on clinical outcomes such as survival or recurrence, is generally lacking. No prospective RCTs studying the clinical utility of these tests were identified. Overall, the results from the review of economic evaluations appear favourable to the tests analysed when these are compared to standard practice, with more unclear results found when comparing one test to another. The positive results are nevertheless subject to important limitations mainly linked to the need to model different sets of data coming from different studies since there are up to date no prospective studies following patients from testing to long-term outcomes CONCLUSIONS - Although there is good evidence proving the prognostic ability of these tests further research is needed to clarify what their clinical utility is. Such research should also reduce the current uncertainties surrounding the potential cost-effectiveness of these tests

Authors' recommendations: Although there is good evidence proving the prognostic ability of these tests further research is needed to clarify what their clinical utility is. Such research should also reduce the current uncertainties surrounding the potential cost-effectiveness of these tests.

Authors' methods: A systematic search of the published literature up to the end of June 2014 on the efficacy, effectiveness and cost-effectiveness of GEP and expanded IHC tests versus current risk stratification tools in early breast cancer was undertaken by consulting electronic databases, including Medline, PreMedline, EMBASE and the Cochrane Library. The clinical evaluation was based on existing systematic reviews; the economic review included full primary and secondary economic evaluations. Bibliographies of articles found via our original search were also checked to identify further relevant studies. No time limitations were imposed

Project Status: Completed

Year Published: 2015

URL for published report: https://doi.org/10.57598/R237C

URL for additional information: https://kce.fgov.be/en/publications/all-reports/gene-expression-profiling-and-immunohistochemistry-tests-for-personalised-management-of-adjuvant

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Belgium

DOI: 10.57598/R237C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: <p>Belgian Health Care Knowledge Centre (KCE)</p>