Quality standard

Quality statement 3: Tumour profiling tests

Quality statement 3: Tumour profiling tests

Quality statement

People with early breast cancer are offered a tumour profiling test if it could help when making decisions about chemotherapy. [new 2016]

Rationale

Tumour profiling tests aim 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 making shared decisions about chemotherapy after surgery. Tumour profiling tests have been shown to be effective in predicting the course of disease in people with oestrogen receptor (ER)-positive, or progesterone receptor (PR)-positive, human epidermal growth factor receptor 2 negative (HER2-negative) and lymph node-negative early breast cancer who have been assessed as being at intermediate risk of distant recurrence. They can also be used for some people with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.

Quality measures

The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.

Structure

Evidence of local arrangements to provide tumour profiling tests for people with early breast cancer if it could help when making decisions about chemotherapy.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from local protocols and service specifications.

Process

a) Proportion of people with ER-positive or PR-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence who receive a tumour profiling test.

Numerator – the number in the denominator who receive a tumour profiling test.

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

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

b) Proportion of women who have been through the menopause with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes who receive a tumour profiling test.

Numerator – the number in the denominator who receive a tumour profiling test.

Denominator – the number of women who have been through the menopause with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

Outcome

a) Breast cancer recurrence (distant and local).

Data source: Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.

b) Mortality from breast cancer.

Data source: NHS Digital's cancer registration statistics report cancer mortality, including counts, age-specific and directly age-standardised rates by ICD10 codes by age group, gender, deprivation and sub-integrated care board geography.

What the quality statement means for different audiences

Service providers (such as secondary care services and specialist breast cancer services) ensure that systems are in place for people with early breast cancer to have a tumour profiling test. Laboratories processing the tests should take part in a UK national external quality-assurance scheme.

Healthcare professionals (such as oncologists, nurses and specialists) ensure that people with early breast cancer have a tumour profiling test if it could help when making decisions about chemotherapy. The tests can be used for people with ER-positive or PR-positive, HER2-negative and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence, according to their indications. They can also be used alongside consideration of clinical risk factors to guide adjuvant chemotherapy decisions for women who have been through the menopause with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes. An oncologist should explain what the test results mean, and the risks and benefits of treatment options based on all available risk factors.

Commissioners ensure that they commission services that undertake tumour profiling tests for people with early breast cancer if it could help when making decisions about chemotherapy.

People diagnosed with a particular type of 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.

Definitions of terms used in this quality statement

Tumour profiling test

EndoPredict, Oncotype DX and Prosigna can be used within their intended purpose to guide adjuvant chemotherapy decisions for people with ER-positive or PR-positive, HER2-negative early breast cancer. [NICE's diagnostic guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer, recommendations 1.1, 1.4 and 1.6]

Intermediate risk of distant recurrence

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. [NICE's diagnostic guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer, recommendation 1.4]

Equality and diversity considerations

Healthcare professionals should consider whether tumour profiling tests are suitable to guide adjuvant chemotherapy decisions for:

  • men with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes, and

  • trans, non-binary or intersex people with ER-positive or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes, depending on their hormonal profile.

[NICE's diagnostic guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer, recommendation 1.1]