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. [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. Gene expression profiling 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 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.

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

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.

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.

Commissioners (such as clinical commissioning groups) ensure that they commission services that undertake gene expression profiling 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

Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (2018) NICE diagnostics guidance 34, recommendation 1.1

Definitions of terms used in this quality statement

Gene expression profiling

EndoPredict, Oncotype DX Breast Recurrence Score and Prosigna are recommended by NICE as options 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.

[Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (NICE diagnostics guidance 34)]

Intermediate risk

A validated tool, such as PREDICT or the Nottingham Prognostic Index, must be used to determine if a person is at intermediate risk of distant recurrence.

[Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (NICE diagnostics guidance 34)]