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Executive Summary

If you are a patient and/or a healthcare professional and would like to inform others about this guide please Click here

If you are a patient and would like some more information about this technology and what it may mean for you, please Click here

Breast cancer affects over 46,000 women per year in England. The NICE guidance for Early and Locally Advanced Breast Cancer (2009) advocates that minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer. 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 cancerous cells are present. Each year, approximately 11,000 women require additional surgery to treat the spread of breast cancer to the lymph nodes.

The result of this technology implementation project show that this intra-operative diagnostic test removes the need for a second surgical procedure for 11,000 patients as a diagnosis can be made within 30-45 minutes. If a node positive result is reported, the operation can continue and the need to wait for a post-operative result (and a possible subsequent second surgical procedure) is therefore removed for every patient.

This How to Why to Guide aims to provide practical guidance to enable the successful implementation of the intra-operative test and to help you to realise the benefits this service improvement can bring. The guide has been specifically designed to save you time, improve patient outcomes and enhance overall productivity. It will be beneficial to all of those Trusts who currently provide, or plan to provide sentinel lymph node biopsy service.

In this site you will find:

The guide also includes useful information which will assist NHS organisations in developing this service, which include:

The Technology Explained

This technology is designed to provide an intra-operative diagnosis by pathology teams of the spread of breast cancer to sentinel lymph nodes of patients undergoing treatment for primary breast cancer. Surgical and pathological teams take a biopsy of the patient's lymph nodes and conduct the test from which the results can be ready within 30-45 minutes. If metastases in the lymph nodes are identified, axillary surgery (which would currently be performed in a second surgical procedure) can be continued to allow the remaining lymph nodes to be removed. This test can play an important role in reducing overall morbidity and hospital length of stay for patients.

This technology plays a significant role in streamlining the diagnostic pathway for breast cancer patients and has the potential to avoid unnecessary (further) surgical intervention and associated morbidity. Delayed Diagnosis of Cancer in England (published by National Patient Safety Agency), recently reported that despite a reduction in cancer mortality in people under the age of 75, survival rates for all women who die within a year of diagnosis of breast cancer, further progress is required to meet and exceed the European average. It is generally agreed that later diagnosis is a major factor in poorer survival rates ( Cancer Reform Strategy, 2010).

Key Benefits of the Technology

  • A reduction in acute hospital admissions. Intra-operative diagnosis reduces the need for a second surgical procedure for 25-30% of patients. NTAC Click here shows that the use of this diagnostic test has the potential to avoid 11,000 second surgeries in the NHS ever year.
  • Reduction in overall length of stay. Avoiding a second surgical procedure would save an average of 5 bed days per patient, which equates to reduction of 24,000 bed days every year across the NHS. This equates to a potential saving of £4m on ward costs alone.
  • Improved efficiency for the NHS. A reduction in patient length of stay will improve efficiency and improve patient care pathways. Click here showed that overall financial savings of £5.01m could be realised in the NHS every year by introducing this technique.
  • Improved quality of life. Removing any delay in diagnosis reduces associated stress for patients and their families.
  • Higher quality services and support for patients. A systematic approach to implementation will deliver an enhanced clinical service and will reduce any delays in accessing adjuvant therapies.
  • Long term savings to the NHS. This is achieved through faster diagnosis and subsequent delivery of appropriate treatment and reduced overall hospital stay.

Click here to be taken to the Benefits vs. Barriers section of this How to Why to Guide. This will compare some of the perceived adoption barriers within the organisation and how they may hinder uptake of this technology.

Impact on Key Policy Areas

National Institute for Health and Clinical Excellence (NICE) guidance for Early and Locally Advanced Breast Cancer advocates that minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer. The availability of an accurate intra-operative test which is concurrent with axillary node dissection offers the potential to avoid up to 11,000 second surgeries per annum with length of stay savings of up to 5 days per patient (this will vary depending on local protocols). This would equate to a saving of up to 24,000 bed days in the UK per annum and would remove the inefficiencies associated with analysing nodal material post-operatively. Click here to see the NTAC economic analysis report where these figures have derived from.

The impact of poorly managed early and locally advanced breast cancer on those patients who could otherwise benefit from a single operation and no waiting for a result following initial surgery signifies a huge burden on the health economy. The risks associated with a second surgical procedure can include infection, reaction to anaesthesia, and possible reductions of lymphoedema, shoulder pain, arm movement and numbness for patients. These complications put significant strain on the NHS and place a significant burden on patients.

The Policy Section of this How to Why to Guide discusses policy in more detail and hosts an array of documentation and supporting resources for Trusts surrounding these areas that you may find helpful.

Summary of Clinical Evidence

The National Institute for Health and Clinical Excellence(NICE) guidance for Early and Locally Advanced Breast Cancer (2009) advocates that minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer. The intra-operative analysis of sentinel lymph nodes offers the opportunity to streamline the management of breast cancer patients as part of a cohesive and comprehensive service, and according to a review in the Histopathology Journal (July 2009), this test is accepted as a reliable technique.

Click here to be taken to the evidence base section of this How to Why to Guide, which will explain the evidence base behind the test in more detail.

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