Malignant melanoma cases represented the seventh most common cancer type in Northern Ireland with an average of 357 cases diagnosed between 2013 and 2017 (Northern Ireland Cancer Registry, 2017a). The projected incidence of melanoma cases is expected to rise to approximately 533 per year by 2025 and 687 per year by 2035 (Northern Ireland Cancer Registry, 2017b).
Background
Sentinel lymph node biopsy (SLNB) has been accepted by many as the gold standard in the management of patients with intermediate prognosis cutaneous melanoma in the USA, Australia, New Zealand and Europe (Norfolk and Norwich University Hospital NHS Foundation Trust, 2015). However, in Northern Ireland this service is not available despite the increasing evidence to support the role of SLNB for this patient group. National Institute for Health and Care Excellence (NICE) guidance on Melanoma: assessment and management states
‘Consider sentinel lymph node biopsy as a staging rather than a therapeutic procedure for people with stage IB–IIC melanoma with a Breslow thickness of more than 1 mm, and give them detailed verbal and written information about the possible advantages and disadvantages’
The guidance also recommends completion lymphadenectomy for those patients whose SLNB shows micro-metastases.
The advantages of having SLNB include that it can help establish if the malignant melanoma has spread to the lymph nodes and is more sensitive than an ultrasound scan at detecting very small deposits of melanoma in the lymph nodes. It can help predict what might happen in the future in terms of survival and patients who have had SLNB may have more access to take part in clinical trials of new treatments to prevent future melanoma.
SLNB is not currently commissioned in Northern Ireland, largely due to the lack of good evidence that people who have the procedure live longer than people who do not have it. This is also true of the subsequent completion lymphadenectomy for those with node positive disease. The impressive results from the use of immunotherapy and BRAF/MEK targeted therapy in advanced melanoma have led to great interest in investigating these agents in resected high-risk disease. Several studies are ongoing, and mature data is beginning to emerge. Patients with node-positive disease would potentially become eligible for the new adjuvant therapies.
Provision of a SLNB service would include the establishment of protocols and guidelines for surgical and laboratory pathways in line with those used by centres of excellence and the development of evidence-based patient information. Having such mechanisms in place would streamline the implementation of an up-to-date equitable SLNB service for patients with melanoma in Northern Ireland.
Scholarship aims and objectives
The overall aim is to develop and implement an effective and efficient SLNB service for patients with malignant melanoma in Northern Ireland:
The Florence Nightingale Travel Scholarship funded a 3-week visit to a leading skin cancer unit in the UK that is a centre of excellence in skin oncology, leading on the development, establishment and evaluation of an SLNB service and the management of the lymphatic basin. The staff there have published widely on their experience. The service provision is for a similar healthcare context, in terms of the population and incidence of melanoma, as that in Northern Ireland. Therefore there are many transferable attributes when considering the introduction of an SLNB service in Northern Ireland.
The visit and areas observed
I was warmly welcomed by the skin cancer CNS team and was familiarised with the dedicated skin cancer unit. The CNS team had prearranged and coordinated the various placements and meetings to ensure that the learning objectives were met over the 3-week period.
Skin cancer multidisciplinary team (MDT) meeting
The skin cancer MDT meeting was similar in format to the skin cancer MDT meeting at my own trust, though I observed some differences and there was opportunity for shared learning. The attendance was similar, consisting of consultant plastic surgeons and teams, consultant dermatologists, consultant pathologists, consultant radiologists, skin cancer clinical nurse specialist and research team and the MDT co-ordinator. The chairperson for the meeting, who was also the MDT co-ordinator, was a consultant oncologist. Each complex skin cancer case was presented with photographs on the screen, which was good practice. All patients requiring SLNB for melanoma were discussed. I had the opportunity to discuss the preparation and planning for the MDT meeting and updates following the meeting.
Skin cancer outpatient clinics
During the visit I attended the skin cancer outpatient clinics of the three dedicated surgeons who carried out SLNB for patients with melanoma. The format was around 20 patients in each clinic with 20-minute time slots per patient. Patients were referred by the GP or dermatologist, with a biopsy-proven skin cancer, and seen on a 2-week wait system. Table 1 shows the referral guidelines used by the centre.
| Inclusion criteria for SLNB |
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| Exclusion criteria for SLNB |
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Newly diagnosed patients were seen first and then patients for review after treatment. Patients referred for SLNB were advised that they would be contacted by the SLNB co-ordinator to arrange pre-assessment and a subsequent date for the procedure as a day case. Waiting time was approximately 6-8 weeks. Contact details for the skin cancer CNS were given at this juncture. Patients were advised at their first clinic visit that they would be telephoned, probably by the skin cancer CNS, with the results of the biopsy when available, whether positive or negative. If the SLNB results were positive a further outpatient appointment was arranged to discuss treatment options. These options included completion lymphadenectomy or high-risk surveillance of the nodal basin with ultrasound scanning and review.
The review patients were seen by either the consultant plastic surgeon or the skin cancer CNS. This included a full skin examination, nodal examination and advice.
Nuclear medicine department
The team included two radiographers, one radiographer assistant and a consultant radiologist. There were two to three pre-arranged slots each week in nuclear medicine for patients requiring SLNB. Patients arrived at the department at around 8 am. The sentinel node localisation protocol was implemented. This involved the patient having four injections of a radiotracer into the primary melanoma site, administered by the radiographer. The patient was then scanned with a single-photon emission computed tomography (SPECT) scanner. This technique, lymphoscintigraphy, is a type of nuclear medicine imaging that provides pictures called scintigrams of the lymphatic system. This is used to identify the sentinel lymph node or the first node to receive the lymph drainage from a tumour and can identify points of blockage in the lymphatic system. The radiographer outside the scanning room observed the images.
The patient then waited outside for approximately 1 hour. The patient was then re-scanned, which took around 25 minutes. Both sets of images were then fused on the system. This identified the first draining lymph node (sentinel node) and any other nodes with radiotracer uptake. The radiographer used a dye and tattoo markings on the skin to identify these areas. The radiographer then checked the imaging and tattoo markings with the consultant radiologist before the patient went to theatre.
Theatre visits
Following the nuclear medicine visit I followed the patient to the theatre. This involved the patient having a general anaesthetic, and the consultant plastic surgeon injected a blue dye into the primary site of the melanoma. The commonly used dyes are isosulphan blue and patent blue V (PBV). A gamma probe (a handheld device containing a scintillation counter) was used to locate sentinel lymph nodes by their radioactivity. Node localisation was achieved with the combination of the injected dye and radioactive tracer. Any identified nodes were excised and a wide local excision of the primary melanoma performed in accordance with local and national guidelines for the management of melanoma. The nodes and wider excision specimen were then sent to the pathology laboratory for analysis and reporting.
Pathology laboratory
I met with a consultant pathologist during my visit. I had a tour of the laboratory and met each of the team members involved in labelling, processing and reporting the SLNB specimens. There were radiation regulations to follow regarding the transportation of SLNB specimens as they contained a radioactive tracer. It was interesting to learn about the particular pathology features of the sentinel lymph nodes that deemed them positive or negative for melanoma. The report issued was very specific regarding each node excised and the wider excision.
SLNB co-ordinator
The SLNB service for patients with melanoma had its own co-ordinator. They reviewed the skin cancer MDT meeting outcomes to obtain a list of patients requiring SLNB. Each patient was tracked on a live database as they required pre-assessment prior to a date being issued for the SLNB procedure. These appointments were arranged by the SLNB co-ordinator and patients were contacted accordingly.
Skin cancer CNS team
Throughout my visit I had daily contact with the skin cancer CNS team. I had the opportunity to shadow the CNS team to follow patients from diagnosis at the breaking bad news clinics to the plastic surgery outpatient clinics to discuss SLNB. I then visited the nuclear medicine department and theatre on at least four occasions to observe the SLNB procedures being performed. I observed the tracking of pathology results and the telephone results clinic. I also saw patients after their SLNB procedure in various settings such as the outpatient clinic, dressing clinic for wound management and the lymphoedema clinic.
The role of the skin cancer CNS team was observed in terms of addressing the educational needs of patients and their families in preparation for SLNB, aiding the decision making process for patients including explaining the advantages and disadvantages of having the procedure and the anticipated outcomes. The ongoing clinical and supportive role of the skin cancer CNS team was pivotal to service provision. I found the direct access system to the team to be invaluable to ensure prompt decision making and management for patients with possible recurrent melanoma or nodal disease. Access to clinical trials was also co-ordinated by the skin cancer CNS team depending on the results of SLNB.
Cancer Information Centre
I visited the centre, which was located within the hospital grounds and was funded by a local charity. The setting was very relaxed and comfortable with different areas to read, make refreshments, and access the internet or to talk and relax. The events hosted included a walk-in centre for patients with cancer and their families to access relevant literature and support groups. There were various support groups available, including a melanoma group that met four times per year. Other facilities included relaxation classes, bereavement groups, a carers' group, access to benefits advisors and counselling sessions. Many of the patients that I met during my visit had accessed this service.
Educational meeting
At the invitation of the skin cancer CNS team I also attended an educational meeting focused on the current provision of SLNB (Spotlight SLNB, organised by Melanoma Focus). Key questions considered at the meeting included:
It was evident that melanoma management is evolving with many units no longer offering completion lymphadenectomy for patients with a positive SLNB and choosing to monitor with imaging such as PET and CT follow-up scanning and ultrasound scanning of the nodal basins. NICE (2015) states that there is no evidence that people who have completion lymphadenectomy live longer than people who do not have it. As discussed at the meeting, a recent large study, the Multicenter Selective Lymphadenectomy Trial (MSLT-II) (Faries et al, 2017), evaluated the usefulness of completion lymphadenectomy in patients with melanoma and sentinel lymph node metastases. Recent trials including MSLT-II have clearly shown that active surveillance of the nodal basin is an efficient way to identify patients who are most likely to benefit from delayed, selective, node-directed treatment. It is believed that completion lymphadenectomy would no longer be routinely performed following a positive SLNB but may be reserved for patients with particular higher-risk features for nodal recurrence. A position paper has since been produced following the meeting (Melanoma Focus, 2019)
Implementing learning from the experience
Synthesis of the travel scholarship experience into practice is ongoing in the absence of a commissioned SLNB service for patients with melanoma in Northern Ireland. However, the information and knowledge gained is being used to inform patients, their families, the management team and various members of the skin cancer team regarding SLNB. The surgical management team has been presented with the findings of the travel scholarship to inform local interim arrangements for patients requiring SLNB. The information has also partly contributed to a position paper for the commissioning of the service in Northern Ireland put forward from the author's Regional Multidisciplinary Team SLNB sub-group to the local commissioning team.
Reflections and key learning
Potential impact on practice
It is important to note that the implementation of advances in melanoma management in Northern Ireland has been beneficial for patients. With the use of more effective therapies, overall survival of metastatic melanoma patients has increased significantly. In the 2006-2009 audit, the 12-month survival to first line chemotherapy was 12-15% (Khan et al, 2012) and preliminary data indicates that this now exceeds 50% with the use of novel systemic anti-cancer therapy (SACT) options.
Between December 2012 and September 2016, there were nine new positive NICE technology appraisal recommendations for systemic therapy use in patients with advanced melanoma. The evidence suggests that without access to SLNB there will be a cohort of patients in Northern Ireland (conservative estimate 30-50 per annum) who will not have the opportunity to access the survival benefits of adjuvant therapies because the potential upstaging from SLNB will be lost. Without SLNB a patient is assigned ‘Nx’ status (lymph nodes have not been assessed) and treated as node negative. A positive result from SLNB could mean the difference between a patient being staged as N0 or Nx (and classed as stage II disease), or N1a/N2a (stage III disease) and consequently being eligible for adjuvant therapy.
An article by Fawzy et al (2012) described the setting up of an effective and efficient SLNB service for malignant melanoma in Norfolk and Norwich University Hospital and advised that the following should be considered when setting up a service:
Summary
The Florence Nightingale Foundation Travel Scholarship has allowed the author dedicated time to observe the infrastructure and daily running of a SLNB service and those involved in the provision of care. This has been an invaluable learning experience allowing access to expert clinical teams to discuss the implementation of a SLNB service. This information and experience has been disseminated to the surgical directorate management team and will be used in the implementation plans for service development. SLNB is considered the standard of care internationally for melanoma staging. There is widespread access to the procedure across the UK except in Northern Ireland and a national position paper has been published to provide a framework to standardise the service.