Information for health professionals about the MammaPrint® test for early breast cancer

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What is the MammaPrint® (70 gene signature) test?

MammaPrint® is a gene profile test (a genomic test of breast cancer tumour cells). It examines 70 different genes to look for changes associated with a higher risk of breast cancer recurrence after treatment. The aim of the MammaPrint® test is to help inform decisions about whether to use chemotherapy after local treatment for early breast cancer.

What did MSAC conclude about the MammaPrint® test?

MSAC did not support public (Government) funding for the MammaPrint® test in Australia. This conclusion was based on a review of the safety, clinical effectiveness and cost-effectiveness.

Why did MSAC reach the conclusion not to support public funding of the MammaPrint® test in Australia?

MSAC based its conclusion on its appraisal of a study known as the MINDACT trial which investigated the use of the MammaPrint® test in a clinical trial setting.

The trial aimed to show whether information provided by the MammaPrint® test could be added to existing clinical information to inform decisions about the use of adjuvant chemotherapy for early breast cancer. The trial showed that, overall, breast cancer outcomes were poorer in women who did not have chemotherapy based on the MammaPrint® test, compared with those who received chemotherapy.

“As a result, MSAC had little confidence that the MammaPrint® test could be used to justify withholding chemotherapy without negatively impacting upon important outcomes, including overall survival.” 
http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1376.1-public

Does this MSAC conclusion apply to other gene profile tests?

MammaPrint® is one gene profile test that has been considered by MSAC for public funding. A number of such tests have been developed to assess the risk of breast cancer recurrence after initial treatment, in order to guide a patient’s decision about the use of chemotherapy.

To date, none of the tests reviewed by MSAC has been considered to provide sufficient evidence of benefit to be approved for public funding in Australia. However, gene profile tests are an active area of research. MSAC’s conclusion in relation to this particular test (MammaPrint®) does not necessarily mean that the Committee would reach the same conclusion for other gene profile tests in the future.

Is the MammaPrint® test available in Australia?

Currently no gene profile tests, including MammaPrint® for use in early breast cancer, are publicly funded in Australia, however patients can choose to personally pay for such a test.

Patients who choose to undertake the MammaPrint® test after being informed about the MSAC findings, should be made aware that there is an out of pocket cost for the test. This is called informed financial consent. Patients should also be made aware that breast cancer tissue is sent overseas for testing.

What should I tell a patient considering having the MammaPrint® test?

A clinician’s role is to provide advice about treatment options relevant to the individual patient. This advice should consider clinical and patient characteristics and include the potential benefits and risks of treatments. The consideration of the MammaPrint® test should be in the context of providing a clear explanation of the MSAC conclusion based on the MINDACT trial.

http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1376.1-public

Current clinical practice involves the use of patient and tumour criteria to determine if chemotherapy is recommended. Patients who choose to undertake the MammaPrint®  test after being informed of the MSAC conclusion, should be advised of the out of pocket costs, as part of informed financial consent and the fact that samples are currently sent overseas for testing.

What should I tell a patient who has had the MammaPrint® test?

Inform the patient that treatment decisions are based on the best available information at the time. There are many factors considered in the decision about whether or not to have chemotherapy, including specific clinical and tumour characteristics.

Recent assessment undertaken by MSAC of the MammaPrint® test considered the results of a randomised controlled trial, the MINDACT trial. Based on the study, MSAC concluded that withholding chemotherapy on the basis of the MammaPrint® test led overall to poorer breast cancer outcomes for some patients. Further details can be found in the MSAC Public Summary Document at http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1376.1-public

If you are not the treating specialist, encourage the patient to discuss any concerns they have associated with the use of the MammaPrint® test with their specialist treating clinicians.

What should I do if I treated patients who have had the MammaPrint® test?

If you have treated a patient who decided not to have chemotherapy after using the MammaPrint® test, consider the need to contact the patient and counsel them  based on the MSAC conclusion with respect to the particular circumstances of the patient.

For more information on MSAC’s conclusion in relation to the MammaPrint® test, visit the MSAC website at
http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1376.1-public 
and supporting information.