New Test for Intra-Operative Breast Cancer Analysis, expert comment
Mr Simon Marsh, Senior Consultant Breast Surgeon comments on the latest NICE Guidance and says that there are different ways to test for the presence of cancer spread. Although approval of the new test is welcome it does not really herald a new or better approach – it is just another option.. He says, “The majority of women with invasive breast cancer need to have one or two lymph nodes removed from the armpit at the time of the breast cancer surgery to find out if the cancer has spread. This is called sentinel lymph node biopsy (SLNB).”
Sentinel Lymph Node Biopsy (SLNB)
He goes on to say, “ The results of the SLNB is important in helping the breast multi-disciplinary team to decide on the need for further surgery to remove more lymph nodes as well as to decide on the need for other treatments such as chemotherapy.”
The importance of Intra-Operative Analysis during Breast Cancer Surgery.
The approach taken by hospitals and different teams often varies depending on the speed and efficiency of diagnostic support services (pathology) as well as the effectiveness of the breast cancer multi-disciplinary team in working together for the benefit of the patient.
Mr Marsh says, “In most hospitals the sentinel lymph glands are analysed some days after the surgery. This means that if there is cancer in the lymph nodes then some women need a second operation to remove more lymph glands. However some hospitals analyse the sentinel lymph nodes while the woman is still asleep. This allows the surgeon to remove more lymph nodes ( if required), while the patient is still asleep. This approach saves many women the need to return for a second operation on the arm pit.”
There are a variety of techniques for analysing the sentinel lymph nodes during surgery. NICE have recently approved an automated system called OSNA (see the statement below).
Mr Marsh says, “At our breast clinic we have been offering intra-operative analysis of the sentinel lymph nodes for some years. We are pleased to see this patient focused approach has now been endorsed by NICE”.
For further information on Simon Marsh and his approach to best practice see - http://www.consultant-search.co.uk/consultants/simon-marsh
NICE Statement
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.
