Introduction to the Technology

Sentinel Lymph Node Biopsy (SLNB)

Cancer Research Uk recently reported that nearly 46,00 people were diagnosed with breast cancer in 2007. Of these, approximately 34,500 (75%) of those diagnosed with breast cancer were "node negative" - e.g. there was no lymph node spread - with the impact of greater breast screening increasing this figure over the next ten years. Under current standards, for those 11,000 patients who were diagnosed as "node positive" (e.g. where lymph node spread was identified), a second surgical procedure (also referred to as "axillary clearance") was performed postoperatively to remove all the lymph nodes from the armpit. Reporting back on whether a lymph node(s) is positive or negative can take up to four weeks in some cases.

Sentinel lymph node biopsy is the standard of care for assessment of lymph-node spread in early breast cancer, and it is the procedure in which the sentinel lymph node is removed and examined to determine whether a lymph node(s) is positive or negative.

SLNB is based on the idea that cancer cells spread (metastasise) in an orderly way from the primary tumour to the sentinel lymph node(s), then to other nearby lymph nodes. The introduction of SLNB in the UK following the publication of several clinical trials, including ALMANAC, resulted in a national training program for surgeons in the UK. The technique has NICE approval and has improved the outcomes of breast cancer as a result of its improved diagnostic accuracy over non-targeted axillary dissection.

Sentinel lymph node biopsy to access an information sheet on Sentinel Lymph Node Biopsy, which is routinely distribute to patients at the The Princess Alaxandra Hospital NHS Trust

The Technology in Use

The National Institute for Health and Clinical Excellence (NICE) Click here advocates that minimal surgery, rather than the complete removal of lymph nodes from the armpit (e.g. "axillary clearance"), should be performed to stage the disease in patients with early invasive breast cancer.

The technology described in this How to Why to Guide relies on a sentinel lymph node biopsy to ensure that an intra-operative test of the sentinel lymph node(s) can take place, and the result provided to surgical teams within 30-45 minutes. The impact of the intra-operative test assures a swift result which can enable surgical teams to make an informed choice on whether or not continue to axillary clearance in the primary operation. The impact of this removes the need to wait for a post-operative result and possible subsequent second surgical procedure. This test has furthermore been proven to be Click here. The recent introduction of axillary ultrasound with cytology to assess nodal status preoperatively now offers accurate identification of women who need axillary clearance. Thus in the UK the number of patients per annum that may benefit from the intra-operative test is likely to be in the region of 75% of diagnosed cases. It is likely that 25-30% of these patients will have sentinel node metastases requiring secondary axillary surgery at a later date.

The technology is patient-focused and means that first definitive treatment for the cancer can take place immediately if required and avoids the requirement for a second inpatient admission and outpatient appointment post-operatively. Patients will also be able to undergo adjuvant therapies sooner which may improve life expectancy.

Click here to access the NICE Quick Reference Guide for Early and Locally Advanced Breast Cancer.

What problems does it solve?

Over the past eight years, inpatient admissions for cancer have risen by 25% and bed days are rising by 1% per year, according to the Cancer Commissioning Toolkit. Streamlining breast surgery by introducing the intra-operative test not only improves overall quality of life for patients, but can further assist in reducing the admissions and overall length of stay for breast cancer patients. Introducing the intra-operative test can also lead to a reduction in the on-going demands on healthcare services (e.g. adjuvant therapies can begin straight after initial surgery) and the wider socio-economic impact (such as the ability to work due to a second surgical procedure).

Sentinel lymph node biopsy is further associated with significantly less morbidity including wound infection, numbness of the arm, shoulder, armpit and chest; seroma, lymphoedema, and shoulder stiffness compared to axillary clearance determined by ultrasound with cytology. This allows accurate axillary staging without the morbidity, hospital stay and "other costs" associated with more traditional extensive axillary dissections. The intra-operative analysis of lymph nodes enhances this improved surgical technique and ensures that Trusts meet their cancer targets which are associated with improving the patient experience whilst reducing unnecessary resource on the NHS.

Decreasing the number of bed days as a result of implementing the intra-operative test can meet a vision set out in the Cancer Reform Strategy (2010) which advocates that more can be done to decrease the number of inpatient bed days. The the Cancer Reform Strategy (2010) states that "inpatient bed days could be reduced by at least 20%. If this level of reduction were achievable across the NHS, there would be a potential efficiency gain of about £190 million, representing approximately 8.1% of the cancer inpatient budget" (£2.332 billion in 2007/08. Source: HES analysis in the Cancer Commissioning Toolkit).

Clinical and Patients Benefits

The availability of an accurate intra-operative test that is concurrent with axillary node dissection offers the potential to avoid approximately up to 11,000 second surgeries per annum with an average length of stay of 5 days (dependent on local protocols on bed days, etc). This would equate to a saving of approximately 24,000 bed days in the UK per annum. This test has recently been accepted as a reliable technique for analysing lymph nodes (according to a 2009 review in Histopathology).

Click here to view NTACs economic analysis report where the above figures have derived from.

Click here to go to the Benefits 'v' Barriers section which gives an essential overview of the benefits that can be achieved.

Providers of the Technology

Two technologies are available for intra-operative sentinel node testing: one is available as a single commercial package, whilst the other combines multiple reagents which require some internal (procurement and clinical) expertise. Whilst it is not NTAC's role to recommend specific manufacturers, a single supplier technology is currently only commercially available from Sysmex Uk Limited.

Last year, a competitor product which was supplied from Veridex (a Johnson & Johnson company), withdrew its product from the marketplace for commercial reasons. In response to the withdrawal of the Veridex system, The Princess Alaxandra Hospital NHS Trust, one of NTACs implementation sites, have established a similar intra-operative molecular test for sentinel lymph node assessment.

The Procurement Section of this How to Why to Guide explains all of the details surrounding the options available to Trusts when purchasing this technology and any associated consumables.