Authors' results and conclusions: Numerous gene expression profiling (GEP) tools, using various methodologies, are available, typically through clinician request, or are being trialled in validation studies. Since the original brief on GEPs for early breast cancer, new evidence is available for three tests, two have entered into the Medical Services Advisory Committee (MSAC) process for public funding, two had no new evidence and six new tests emerged, including one that is in the MSAC process and another that is approved for use in Australia. Most studies provided a low-level of prognostic evidence, and no studies that considered direct evidence or the impact of the prognostic tool on change in management and health outcomes were identified. In general, this update does not provide any further evidence on the clinical utility of these tests; the results of two trials (using OncotypeDX and Mammaprint) are awaiting to inform this.

Authors' recommendations: There are numerous gene expression profiling tests approved for marketing in Australia for the identification of women who may respond to treatment for breast cancer. Clinical utility of these tests has not, as yet, been proven, as the current evidence base and a lack of long-term follow-up data does not demonstrate that testing, results in changed clinical outcomes for these patients. Of concern is that, on the basis of these test results, women may be denied treatment that may, in fact, be of benefit to them. It is also of concern that only a small subset of women would be good candidates for gene expression profiling testing, however, consumer demand for these tests is likely to increase. HealthPACT does not support public investment in this technology in clinical practice at this time and not until after consideration of published results of studies demonstrating clinical utility. Therefore, HealthPACT recommends that the evidence for gene expression profiling tests for breast cancer prognosis be reviewed in 36 months.

Project Status: Completed

Year Published: 2016

URL for published report: Not Available

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Adelaide Health Technology Assessment

Contact Address: School of Public Health, Mail Drop 545, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8313 4617

Contact Name: ahta@adelaide.edu.au

Contact Email: ahta@adelaide.edu.au

Copyright: Adelaide Health Technology Assessment (AHTA)