Note from the Scottish Intercollegiate Guidelines Network (SIGN) and National Guideline Clearinghouse (NGC): In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.
The strength of recommendation grading (A-D) and level of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) are defined at the end of the "Major Recommendations" field.
Prevention, Surveillance, and Genetics
D - Brochures and leaflets should be used to deliver preventive information on melanoma to the general public.
Diagnosis and Prognostic Indicators
D - Clinicians should be familiar with the 7 point or the ABCDE checklist for assessing lesions (see Tables 3 and 4 in the original guideline document).
D - Clinicians using hand held dermatoscopy should be appropriately trained.
D - Health professionals should be encouraged to examine patients’ skin during other clinical examinations.
D - A suspected melanoma should be excised with a 2-mm margin and a cuff of fat.
C - If complete excision cannot be performed as a primary procedure, a full thickness incisional or punch biopsy of the most suspicious area is advised.
C - A superficial shave biopsy is inappropriate for suspicious pigmented lesions.
D - The macroscopic description of a suspected melanoma should:
- state the biopsy type, whether excision, incision, or punch
- describe and measure the biopsy (in mm)
- state the size of the lesion in mm and describe the lesion in detail (shape, pattern of pigment distribution, presence or absence of a nodular component, and presence or absence of ulceration)
- state the clearance of the lesion (in mm) from the nearest lateral margin and the deep margin.
D - Selection of tissue blocks:
- the entire lesion should be submitted for histopathological examination
- the lesion should be sectioned transversely at 3 mm intervals and the blocks loaded into labeled cassettes
- cruciate blocks should not be selected (they limit the assessment of low power architectural features such as symmetry).
Note: a photograph of the macroscopic specimen may be of great value, especially if the precise origins of labeled blocks are drawn onto the photograph to permit exact orientation.
B - The histogenetic type should be included in the pathology report.
B - The growth phase characteristics should be stated in the pathology report of all melanomas except nodular melanomas which, by the time of diagnosis, show only vertical growth phase characteristics.
B - An accurate (to within 0.1 mm) measurement of the Breslow thickness should be included in the pathology report for any melanoma that has an invasive component.
B - The Clark level of invasion should be provided when the lesion has a Breslow thickness <1 mm.
B - The presence or absence of histological evidence of epidermal ulceration should be noted in the pathology report.
C - If late regression is apparent, it should be included in the pathology report.
B - Identification of lymphatic space invasion and/or microscopic satellites should be included in the pathology report.
B - If the likelihood of survival is calculated using the Cochran model, the breadth of any epidermal ulcer should be measured by micrometer and stated in the pathology report.
Surgical Management and Staging
D - In pTis (melanoma in situ) a surgical excision margin of 2 to 5 mm is recommended to achieve complete histological excision. (p = pathological; T = tumour)
B - In pT1 (melanoma 0- to 1-mm thickness) a surgical excision margin of 1 cm is recommended.
B - In pT2 (melanoma 1- to 2-mm thickness) a surgical excision margin of 1 to 2 cm is recommended.
B - In pT3 (melanoma 2- to 4-mm thickness) a surgical excision margin of 2 cm is recommended.
D - In pT4 (melanoma >4-mm thickness) a surgical excision margin of 2 cm is recommended.
D - The microscopic clearance of the tumour from the nearest lateral margin and from the deep margin should be stated (in mm) for all excision biopsies.
B - Radical lymph node dissection requires complete and radical removal of all draining lymph nodes to allow full pathological examination.
B - Elective lymph node dissection should not be routinely performed in patients with primary melanoma.
B – Sentinel lymph node biopsy (SLNB) should be considered as a staging technique in patients with a primary melanoma >1 mm thick or a primary melanoma <1 mm thick of Clark level 4 (see section 3.8.5 of the original guideline document).
Further Investigations and Non-surgical Staging
C - Chest x-ray, ultrasound scanning, and computerised tomography scanning are not indicated in the initial assessment of primary melanoma unless indicated for investigation of clinical symptoms and signs.
D - Routine blood tests are not indicated in staging asymptomatic melanoma patients.
Adjuvant Treatment of Stage II and III Disease
D - The routine use of adjuvant radiotherapy is not recommended for patients who have had therapeutic lymph node dissections.
A - Adjuvant interferon should not be used for American Joint Committee on Cancer (AJCC) stage II and III melanoma patients other than in a trial setting.
Patient Follow-Up in Stage I, II and III Disease
D - Patients who have had melanoma in situ do not require follow-up.
D - Routine full blood counts, liver function tests, tumour markers, chest x-rays, ultrasound scans, computed tomography, and lactate dehydrogenase are not recommended as part of a follow-up schedule in the asymptomatic patient.
B - Healthcare professionals and members of the public should be aware of the risk factors for melanoma.
C - Individuals identified as being at higher risk should be
- advised about appropriate methods of sun protection
- educated about the diagnostic features of cutaneous melanoma
- encouraged to perform self examination of the skin
D - Genetic testing in familial or sporadic melanoma is not appropriate in a routine clinical setting and should only be undertaken in the context of appropriate research studies.
Management of Stage IV Disease
A - Dacarbazine (DTIC) is the standard single agent of choice in stage IV melanoma.
A - Multiple drug regimens including those with tamoxifen and interferon alpha do not improve survival compared to single agent DTIC and are not recommended outside of clinical trials.
D - Single dose radiotherapy of a least 8 Gy is an effective treatment for bone metastases.
D - Patients with good performance status, favourable response to corticosteroid treatment, and the absence of systemic disease and who harbour favourable central nervous system (CNS) disease should be considered for surgical resection of their CNS disease.
D - If surgery is not possible, whole brain radiotherapy combined with corticosteroids may help palliate neurological symptoms.
B - Patients with advanced melanoma require a coordinated multiprofessional approach with input from a specialist palliative care team.
D - Patients with poorly controlled symptoms should be referred to specialist palliative care at any point in the cancer journey.
Information for Patients
C - Patients should receive targeted information throughout their journey of care.
Grades of Recommendation
A: At least one meta-analysis, systematic review of randomised controlled trials (RCTs), or RCT rated as 1++ and directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or
Extrapolated evidence from studies rated as 2++
D: Evidence level 3 or 4; or
Extrapolated evidence from studies rated as 2+
Levels of Evidence
1++: High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias
1+: Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-: Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++: High quality systematic reviews of case control or cohort studies; high quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal
2+: Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal
2-: Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal
3: Non-analytic studies, e.g. case reports, case series
4: Expert opinion