PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
Melanoma.
Bibliographic Source(s)
Finnish Medical Society Duodecim. Melanoma. In: 23955 [internet]. Helsinki, Finland: Wiley Interscience. John Wiley & Sons; 2010 Jun 4 [various].
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Melanoma

Guideline Category
Diagnosis
Evaluation
Management
Prevention
Treatment
Clinical Specialty
Dermatology
Family Practice
Internal Medicine
Oncology
Surgery
Intended Users
Health Care Providers
Physicians
Guideline Objective(s)

Evidence-Based Medicine Guidelines collect, summarize, and update the core clinical knowledge essential in general practice. The guidelines also describe the scientific evidence underlying the given recommendations.

Target Population

Patients with melanoma or suspected melanoma

Interventions and Practices Considered

Prevention

Prevention measures including reduced exposure to ultraviolet radiation

Management/Treatment

  1. Naevus removal and referral to surgeon
  2. Excision and sentinel lymph node biopsy
  3. Drug treatment including adjuvant treatment, palliative care, and subcutaneous alfa interferon (IFN-alfa)
  4. Radical evacuation of lymph node region, if applicable
  5. Referral to an oncologist
  6. Ultrasound and fine needle biopsy, if applicable
  7. Full body computed tomography (CT)
  8. Metastasectomy
  9. Follow-up including detection of possible skin or lymph node recurrences and new primary tumors through general health and symptoms check, palpation of site, and further investigations
Major Outcomes Considered
  • Sensitivity and specificity of diagnostic tests
  • Relapse-free survival and overall mortality rates
  • Adverse effects of treatment

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The evidence reviewed was collected from the Cochrane database of systematic reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). In addition, the Cochrane Library and medical journals were searched specifically for original publications.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Grading the Quality of Evidence

Code Quality of Evidence Definition
A High Further research is very unlikely to change confidence in the estimate of effect.
  • Several high-quality studies with consistent results
  • In special cases: one large, high-quality multi-centre trial
B Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.
  • One high-quality study
  • Several studies with some limitations
C Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.
  • One or more studies with severe limitations
D Very Low Any estimate of effect is very uncertain.
  • Expert opinion
  • No direct research evidence
  • One or more studies with very severe limitations

GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group (modified by the EBM Guidelines Editorial Team).

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Not stated
Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

The levels of evidence [A-D] supporting the recommendations are defined at the end of the "Major Recommendations" field.

Essentials

  • Any suspicious naevus can be removed in primary health care.
  • Melanoma should be suspected if a pre-existing naevus (mole) on the skin increases in size, changes colour, bleeds or discharges purulent material. The presence of so-called "satellite lesions" are also suggestive of melanoma. Melanoma may also develop on a previously healthy skin or mucous membrane.
  • A changed lesion suspected to be melanoma must be excised as soon as possible for an accurate histopathological diagnosis. If it is not possible to remove the lesion as a whole, a biopsy can be taken.
  • If there is a strong suspicion of melanoma, the patient should be referred directly to the care of a surgeon.

Epidemiology and Risk Factors

  • Melanoma is currently the most rapidly increasing malignancy in white populations.
  • Exposure to ultraviolet radiation through sunlight is the major risk factor.
  • Melanoma cannot be excluded based on clinical presentation alone (See Pictures 1 and 2 in the original guideline document), and it may develop on a previously healthy looking skin. The specificity of clinical checklists designed to detect the presence of melanoma can be fairly good, but their sensitivity is limited (Whited & Grichnik, 1998) [C].

Prevention

  • Preventive measures seek to reduce the effects of ultraviolet (UV) radiation.
  • The risk of melanoma transformation in a stable pigmented naevus is too rare to justify prophylactic removal of naevi in patients with numerous naevi.

Lesions Suspected to Be Melanoma

  • See Pictures 3, 4, 5, 6, 7, and 8 in the original guideline document.
  • Melanoma should be suspected if a naevus
    • Has clearly increased in size or changed colour (See Pictures 9 and 10 in the original guideline document)
    • Is exceptionally large (See Picture 11 in the original guideline document)
    • Is surrounded by satellite lesions
    • Occurs on the site of a previously removed melanoma
  • The suspicious naevus should be removed without delay, or the skin change biopsied, in primary health care. If there is a strong suspicion of melanoma, the patient should be referred directly to the care of a surgeon.
  • Wide excision margins have not been shown to affect survival rates, even though the risk of local recurrence may be higher when narrower margins are used (Sladden et al., 2009) [C].

Initial Stage Management

  • If the pathology report confirms melanoma, the patient must urgently be referred to a surgeon for follow-up treatment.
  • If primary melanoma was confirmed by biopsy, the area will need to be excised more radically and a sentinel lymph node biopsy carried out. No other imaging or laboratory investigations are routinely carried out at the time of surgery or during the later follow-up period. High risk patients are an exception and may require individual monitoring under specialist care.

Surgery for Melanoma

  • The surgery involves removing more skin and subcutaneous tissue around the tumour. The extent of the excision is dependent on the site of the tumour, its thickness (Breslow scale) and the extent of infiltration (Clark scale).
  • Very superficial melanomas (Clark I–II, Breslow <1 mm) are excised with a 1 cm margin of healthy tissue. Thicker melanomas are excised with a margin of 2–5 cm. Skin flaps or free grafts are used to reconstruct the surgery site.
  • The majority of patients will undergo a sentinel node biopsy in order to establish the extent of the disease.

Drug Treatment

  • Drug treatment of melanoma consists either of
    • Adjuvant treatment which aims to reduce the recurrence of high risk melanoma, or
    • Palliative care of advanced disease.
  • Factors that would predict the efficacy of different oncological treatments are not well known in melanoma.
  • There are no standardised protocols for adjuvant treatment.
  • So far, cytotoxic drugs have not been shown to be beneficial in adjuvant treatment.
  • Subcutaneous alfa interferon (IFN-alfa) has been used as an adjuvant in individually selected patients at high risk of recurrence. It increases relapse-free survival but no difference in overall mortality has been proven. The treatment is associated with a significant number of adverse effects (Crosby, Mason, & Savage, 2005) [A].

Advanced Melanoma

Locally Advanced Melanoma

  • The involvement of the sentinel lymph node is the strongest single prognostic factor in deep melanomas and in those of intermediate thickness.
  • Sentinel lymph node examination is usually performed in patients who are diagnosed with a ≥1.0 mm thick skin melanoma and/or in whom the melanoma shows other features of activity (e.g. ulceration or blood vessel invasion).
  • If the sentinel node biopsy shows metastatic involvement, radical evacuation of the lymph node region in question must be carried out either during or after the primary surgery.
  • All patients with metastasis in the sentinel node and/or other regional lymph nodes must be referred to an oncologist. These patients will undergo imaging studies and the oncologist will devise an individual treatment or follow-up programme.
  • Locally advanced melanoma is characterised by local recurrences in the scar, satellite lesions or in-transit metastases as well as regional lymph node metastases. The management of all these involves surgical excision.
  • If the patient has palpable lymph nodes and there is a clinical suspicion of melanoma spreading into regional lymph nodes, an ultrasound examination and a fine needle biopsy should be carried out before surgical excision and possible sentinel node examination. If these investigations reveal metastases, a full-body computed tomography (CT) scan is usually performed before the evacuation of lymph nodes.
    • An ultrasound examination does not replace a sentinel node examination as it is a less accurate means of determining nodal status (Tregnaghi et al., 1997; Bossi et al., 2001). Sentinel lymph node examination is, however, not needed if ultrasonography and/or needle biopsy already reveal metastasizing.
  • If a patient with melanoma has palpable lymph nodes he/she may be referred directly to a surgeon.

Metastatic Melanoma

  • Individual treatment planning is needed for melanoma with distal metastases.
    • If melanoma has spread only to the regional lymph nodes they must be removed surgically (see above).
    • Metastasectomy may be an option for patients with isolated distal metastasis.
    • Results have been achieved with cytotoxic drugs and interferon even in the treatment of advanced melanoma. However, the treatment remains only palliative.

Follow-up of a Patient with Melanoma

  • The follow-up focuses on detecting possible skin or lymph node recurrences as well as new primary tumours. The patient is taught techniques of self examination.
  • Follow-up appointments should be made every 3–6 months until two years have lapsed from the diagnosis. Thereafter the patient should be checked every 6 months for at least 5 years. The venue of the follow-up appointments is decided locally. It is desirable that the patient is always seen by the same doctor.
  • If the patient has numerous moles or dysplastic naevus syndrome, a hereditary condition, the follow-up of melanoma should be carried out at a skin clinic. Good quality photographs facilitate follow-up, and these patients warrant lifelong follow-up.
  • During a follow-up examination, the patient's general health and symptoms should be checked, and the site where melanoma was removed and regional lymph nodes should be palpated.
    • Melanoma satellites often appear as subcutaneous lumps and are seen as dark spots under the skin. The first sites of metastasis are the regional lymph nodes, which must be closely monitored by palpating.
    • If clinical examination is suggestive of advanced melanoma, the following investigations are recommended: basic blood count, liver function tests, chest x-ray and either an ultrasound examination of the liver or full-body CT scanning.

Related Evidence

Refer to the original guideline document for related evidence, including Cochrane reviews and other evidence summaries.

Definitions:

Grading the Quality of Evidence

Code Quality of Evidence Definition
A High Further research is very unlikely to change confidence in the estimate of effect.
  • Several high-quality studies with consistent results
  • In special cases: one large, high-quality multi-centre trial
B Moderate Further research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.
  • One high-quality study
  • Several studies with some limitations
C Low Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.
  • One or more studies with severe limitations
D Very Low Any estimate of effect is very uncertain.
  • Expert opinion
  • No direct research evidence
  • One or more studies with very severe limitations

GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group (modified by the EBM Guidelines Editorial Team).

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

Concise summaries of scientific evidence attached to the individual guidelines are the unique feature of the Evidence-Based Medicine Guidelines. The evidence summaries allow the clinician to judge how well-founded the treatment recommendations are. The type of supporting evidence is identified and graded for select recommendations (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Accurate identification and diagnosis and appropriate management of melanoma

Potential Harms

Reported adverse effects of high-dose alfa interferon include myelosuppression (24% at high dose), hepatotoxicity (15% at high dose), neurotoxicity (28% at high dose), malaise, fever, and flu-like symptoms.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Finnish Medical Society Duodecim. Melanoma. In: 23955 [internet]. Helsinki, Finland: Wiley Interscience. John Wiley & Sons; 2010 Jun 4 [various].
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Jun 4
Guideline Developer(s)
Finnish Medical Society Duodecim - Professional Association
Source(s) of Funding

Finnish Medical Society Duodecim

Guideline Committee

Editorial Team of EBM Guidelines

Composition of Group That Authored the Guideline

Primary Authors: Heli Majamaa and Pia Vihinen

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

This guideline is included in "EBM Guidelines. Evidence-Based Medicine" available from Duodecim Medical Publications, Ltd, PO Box 713, 00101 Helsinki, Finland; e-mail: info@ebm-guidelines.com; Web site: www.ebm-guidelines.com External Web Site Policy.

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on May 2, 2011.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...