The National Institute for Health and Care Excellence has recommended a new test for surgeons to use during operations to discover if breast cancer has spread.

The test - the RD-100i OSNA system produced by Sysmex UK - is used while surgery to remove breast cancer tumours is carried out. It can detect if the cancer has spread to lymph nodes in the armpit.

At present, both patients and clinicians have to wait for the results of a biopsy taken during the initial surgery before arranging a second operation if the disease has spread.

NICE recommends that whole lymph node analysis using the RD-100i OSNA system is an option for detecting sentinel lymph node metastases during breast surgery in people with early invasive breast cancer. Using the RD-100i OSNA system will allow test results to be available to the surgical team during the initial operation to help decide if any lymph nodes should be removed at the same time as the initial tumour.

Around 11,000 people with newly diagnosed breast cancer need additional surgery to manage the spread of the disease to the lymph nodes every year. When cancer cells become detached from the main breast tumour, they can be carried in the lymph to the armpit (axillary) lymph nodes. The first armpit lymph node to which cancer is most likely to spread is known as the sentinel lymph node. Sometimes, there can be more than one sentinel lymph node.

In current NHS clinical practice the sentinel lymph nodes are removed with the main tumour during breast cancer surgery. These are then biopsied to detect whether the breast cancer has spread. The results from the biopsy can take up to 15 working days and if the results are positive, the patient will have a second operation to remove the remaining lymph nodes.

The RD-100i OSNA system is able to detect the presence of biological markers that are associated with metastatic spread in sentinel lymph node samples. The intention is that the test results are available during surgery and may be used to decide if any lymph nodes should be removed at the same time as the initial tumour. This could avoid the need for a second operation and allow subsequent treatments such as chemotherapy to begin earlier. The tests can also analyse the whole lymph node and therefore may reduce the risk of a micrometastasis being missed.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “For people with breast cancer and their families, waiting to hear if the disease has spread can cause significant distress and anxiety. If the test is positive, and a second operation is needed to remove more of the axillary lymph nodes, the second operation can be technically more difficult and result in a higher risk of complications (because it will involve operating on the same area of the breast and armpit as the first operation).

“The Committee heard from a patient expert that the option of not having to have a second operation was an important consideration for patients. The Committee also considered that the accuracy of histopathology may vary depending on the number and size of the lymph node sections examined. The Committee therefore concluded that analysis of sentinel lymph nodes using the RD-100i OSNA system during operations had considerable advantages over traditional histopathology testing and had the potential to reduce both clinical complications, and patient anxiety and distress.”

NICE recommends that a national registry is developed to collect data on the use of the RD-100i OSNA system in detecting sentinel lymph node metastases during breast cancer surgery. It also recommends that data on all patients having whole lymph node analysis by the RD-100i OSNA system should be submitted to this registry. These data should be integrated with data from other registries for breast cancer where appropriate.

The guidance does not recommend the Metasin test for detecting sentinel lymph node metastases in people with early invasive breast cancer in routine clinical NHS practice. Although the Metasin test shows promise, the guidance recommends the development of robust evidence to demonstrate its utility in clinical practice.

Ends

Notes to Editors

About the guidance

1. The guidance is available on the NICE website.

2. The RD-100i OSNA system (Sysmex UK) is used during breast surgery in people with early invasive breast cancer who have a sentinel lymph node biopsy and in whom removal of lymph nodes in the armpit is an option.

3. The comparator used in the assessment is postoperative histopathology, the usual approach used in the NHS, in which the sentinel lymph nodes are fixed in paraffin blocks, sliced very thinly to produce sections that are mounted on slides, stained and then examined under a microscope by a consultant histopathologist. The time to receive results from histopathology is usually between 5 and 15 working days in the NHS.

4. The cost of the RD-100i OSNA hardware is approximately £70,000. The unit cost of testing using the RD-100i OSNA system was £350.

About breast cancer

1. Breast cancer is one of the most common cancers in women in England and Wales; there are about 46,000 new cases diagnosed and 10,900 deaths recorded each year. Around 1 in 9 women develop breast cancer at some stage in their life.

2. Most breast cancers develop in women over 50 years, but they can also occur in younger women and, in rare cases, in men. There are around 260 cases of breast cancer diagnosed and 68 deaths recorded in men in England and Wales each year.

3. Breast cancer spreads by local spread to nearby tissues, or by regional or distant spread through the circulatory or lymphatic system. Spread through the lymphatic system is of relevance for this evaluation. It occurs when cancer cells become detached from the main breast tumour and are then usually carried in the lymph to the axillary (armpit) lymph nodes, most likely the sentinel lymph nodes.

4. Lymph nodes are often used to measure the extent of the disease because their function is to monitor lymph,which carries waste products from cells such as bacteria and viruses. Lymph nodes contain various immune system cells, which trigger an immune response if a foreign substance is detected,and soare one of the earliest sites of spread for cancer.

About the NICE Diagnostics Assessment Programme

5. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance

6. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter: @NICEComms.