Cancer tackled by NTAC

Breast Cancer is now the most common type of cancer in the UK. Approximately 46,000 women were diagnosed with breast cancer in 2006 and over the last 25 years there has been a stark increase in the incidence of women getting breast cancer in the UK. Diagnosis and treatment has always been a major focus for the NHS and it has been a priority of the NHS Technology Adoption Centre (NTAC) to deliver projects associated with cancer to improve the outcomes and quality of life for patients suffering from this illness. In 2008 NTAC initiated a project with the aim of understanding the barriers to adoption for a technology that intraoperatively analyses sentinel breast lymph nodes of breast cancer patients during the first surgical operation. This offers the opportunity to make cancer treatment more efficient, improving clinical outcomes for patients by eliminating the need for subsequent surgery in some cases. Breast cancer poses an increased risk of the disease spreading to other parts of the body, in the first instance, usually to the breast lymph nodes. Normally, a permanent section histological examination (H&E), will be performed by the surgeon and a biopsy sent to the pathology laboratory, where a histopathologist will diagnose if the cancer has spread or metastasised to the lymph nodes. Unfortunately there can sometimes be a delay in receiving the results for an H&E and there is the potential to miss between 10% and 15% of clinically relevant metastases. If there has been metastasis of the cancer, patients will be invited to the hospital for an axillary clearance, which requires a second surgical operation. This means that there is a level of inefficiency for the hospital in terms of theatre management and inconvenience in terms of a further hospital stay for the patient. There is also a clinical risk for patients as the cancer has more time to metastasise from the lymph node in the time between the two operations. The Breast Lymph Node Assay (BLNA) technology aims to streamline this process. The technology is designed to provide an intraoperative diagnosis, provided by pathology teams, of the spread of metastatic breast cancer cells to sentinel lymph nodes of patients undergoing lumpectomy and axillary clearance. The surgical and pathological teams take a biopsy of the patient’s lymph nodes and conduct the test intraoperatively from which the results can be ready in between 30 and 45 minutes. If metastases in the lymph nodes has occurred the breast surgery can be continued to allow the lymph nodes to be removed. The process could play a role in the uptake/improvement of sentinel lymph node biopsy, which has a NICE recommendation, and therefore indirectly facilitate a reduction in breast cancer patient morbidity and length of hospital stay.

Implementation potential

The initial findings of the ALMANAC Sentinel Lymph Node Biopsy (SLNB) trial indicate that greater than 50% of women initially included into the trial passed the exclusion criteria, (54% were excluded due to tumour size greater then 3cm or axillary involvement), and were suitable for SLNB. The recent introduction of axillary ultrasound with cytology to assess nodal status preoperatively now offers accurate identification of women who need axillary clearance. In the UK the number of patients per annum that may benefit from an intraoperative Breast Lymph Node Assay is likely to be in the region of 75% of diagnosed cases. It is likely that 25% to 30% of these patients will have sentinel node metastases requiring secondary axillary surgery at a later date. The availability of an accurate intraoperative breast lymph node assay concurrent with axillary node dissection offers the potential to avoid around 11,000 second surgeries. A saving of approximately one bed per cancer patient and five bed days per breast cancer patient is possible in the UK per annum, according to an independent analysis conducted by York Health Economics Consortium which can be found on the NTAC breast cancer How to Why to Guide. The technology is patient-focused and means that definitive treatment for the cancer can take place immediately if required and avoids the requirement for a second outpatient appointment and admission. Patients will also be able to undergo adjuvant therapy sooner, thus increasing life expectancy. NTAC initiated the BLNA Technology Implementation Project in 2008, and it has now been completed. NTAC hopes to encourage implementation of the technology systematically across the NHS by highlighting how organisations involved in the project have overcome the identified barriers to adoption. Four hospital Trusts were part of this project, all of which were selected to identify the barriers to adopting the technology and to overcome them with the assistance of NTAC. They include Sunderland NHS Foundation Trust, University Hospitals of Morecambe Bay, University Hospital of North Staffordshire and the Princess Alexandra NHS Trust (Harlow). Two “Mentor” sites, that were using the technology prior to the initiation of the project, also formed part of the team. Their role has been to provide clinical mentorship to implementation teams and to work with frontline teams to identify and overcome the barriers to adoption and to help avoid the bottlenecks that were faced with implementing the technology into routine clinical care.