Leading the fight against breast cancer

14th August 2013

 

Last week saw the approval by the National Institute for Health and Care Excellence (NICE) of a new test enabling surgeons to detect the spread of breast cancer tumours at a much earlier stage. NICE explains how the test will help to improve patient care.

NICE published guidance in August as part of its diagnostics assessment programme recommending 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 axillary lymph nodes. The first armpit lymph node to which cancer is most likely to spread is known as the 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.

Commenting on the guidance 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 also considered the Metasin test but does not recommend this 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.

The NICE guidance on the RD-100i OSNA system is available on the NICE website at http://guidance.nice.org.uk/DG8
 

 

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