Quality standard

Quality statement 3: Gene expression profiling

Quality statement 3: Gene expression profiling

Quality statement

People with oestrogen receptor-positive (ER-positive), human epidermal growth factor receptor 2-negative (HER2-negative) and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence are offered gene expression profiling with Oncotype DX. [new 2016]

Rationale

Gene expression profiling aims to identify certain genes found in breast cancer tumours. Testing for the levels of expression of these genes can give an indication of how a tumour might develop, which can help in planning treatment. Oncotype DX has been shown to be effective in predicting the course of disease in people with ER-positive, HER2-negative and lymph node-negative early breast cancer who have been assessed as being at intermediate risk of distant recurrence. This information can help with decisions about prescribing chemotherapy after surgery.

Quality measures

Structure

Evidence of local arrangements to provide gene expression profiling with Oncotype DX for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.

Data source: Local data collection.

Process

Proportion of people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence who receive gene expression profiling with Oncotype DX.

Numerator – the number in the denominator who receive gene expression profiling with Oncotype DX.

Denominator – the number of people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.

Data source: Local data collection.

Outcome

a) Breast cancer recurrence (distant and local).

Data source: Local data collection.

b) Incidence of adverse events from chemotherapy.

Data source: Local data collection.

c) Mortality from breast cancer.

Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care services and specialist breast cancer services) ensure that systems are in place for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence to have gene expression profiling with Oncotype DX.

Healthcare professionals (such as doctors, nurses and specialists) ensure that people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence have gene expression profiling with Oncotype DX.

Commissioners (such as clinical commissioning groups) ensure that they commission services that undertake gene expression profiling with Oncotype DX for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence.

What the quality statement means for patients, people using services and carers

People diagnosed with a particular type of early breast cancer (called oestrogen receptor-positive, human epidermal growth factor receptor 2-negative and lymph node-negative early breast cancer), who have been assessed as being at particular risk of the cancer spreading, are offered a test that can help to predict how the cancer might develop. This information can be used to help with decisions about chemotherapy after surgery to remove the cancer.

Source guidance

Definitions of terms used in this quality statement

Gene expression profiling with Oncotype DX

At the time of publication (June 2016), Oncotype DX was the only test (of four available to the NHS) recommended by NICE as an option for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative and lymph node-negative early breast cancer who are assessed as being at intermediate risk of distant recurrence.

[Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat (NICE diagnostics guidance 10)]

Intermediate risk

Intermediate risk of distant recurrence is defined as a Nottingham Prognostic Index (NPI) score above 3.4. It is anticipated that an NPI score can be simply calculated from information that is routinely collected about people with breast cancer. The NICE diagnostics guidance also highlights other decision-making tools or protocols are also currently used in the NHS and these may also be used to identify people at intermediate risk.

[Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat (NICE diagnostics guidance 10)]