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Practice Point
Gene expression profiling
If considering the use of tumour gene expression profiling tests to inform decisions about the use of adjuvant chemotherapy for patients with breast cancer, be aware that the clinical utility of these tests has not yet been established. Discuss with the patient the potential benefits (reduced adverse events due to avoiding chemotherapy) and potential harm (breast cancer recurrence that might have been prevented) of using these.
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How this guidance was developed
Although international recommendations regarding the use of gene expression profiling tests were identified, these were considered less relevant to the Australian health care context than the findings of multiple recent systematic reviews of the clinical evidence undertaken by the Australian government using GRADE methods. This practice point was developed based on eight recent systematic reviews: one for Mammaprint, six for OncotypeDx and one for Prosigna. Importantly, these systematic reviews focused on the impact of using gene expression profiling tests for those women in whom the benefit of adding chemotherapy to endocrine therapy is unclear. These systematic reviews found: RCT evidence (the MINDACT trial) that the use of Mammaprint is associated with poorer overall survival outcomes for women who avoid the use of chemotherapy on the basis of the Mammaprint test results; inconclusive RCT evidence (the TAILORx trial) that the use of OncotypeDx is non-inferior or superior to current clinical practice (consideration of clinical and histopathological information); and insufficient evidence (no RCT) to determine the relative performance of Prosigna.
Related guidance by topic
Gene expression profiling
Practice Point
If considering the use of tumour gene expression profiling tests to inform decisions about the use of adjuvant chemotherapy for patients with breast cancer, be aware that the clinical utility of these tests has not yet been established. Discuss with the patient the potential benefits (reduced adverse events due to avoiding chemotherapy) and potential harm (breast cancer recurrence that might have been prevented) of using these.
Principles in action
Patient-centred care
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Discuss out of pocket costs
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Safe and quality care
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Communication
Useful Links
Although international recommendations regarding the use of gene expression profiling tests were identified, these were considered less relevant to the Australian health care context than the findings of multiple recent systematic reviews of the clinical evidence undertaken by the Australian government using GRADE methods. This practice point was developed based on eight recent systematic reviews: one for Mammaprint, six for OncotypeDx and one for Prosigna. Importantly, these systematic reviews focused on the impact of using gene expression profiling tests for those women in whom the benefit of adding chemotherapy to endocrine therapy is unclear. These systematic reviews found: RCT evidence (the MINDACT trial) that the use of Mammaprint is associated with poorer overall survival outcomes for women who avoid the use of chemotherapy on the basis of the Mammaprint test results; inconclusive RCT evidence (the TAILORx trial) that the use of OncotypeDx is non-inferior or superior to current clinical practice (consideration of clinical and histopathological information); and insufficient evidence (no RCT) to determine the relative performance of Prosigna.
Related guidance by topic
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