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## Complete Summary

#### GUIDELINE TITLE

Skin melanoma.

#### BIBLIOGRAPHIC SOURCE(S)

Dutch Working Group on Melanoma. Skin melanoma. Utrecht, The
Netherlands: Association of Comprehensive Cancer Centres (ACCC); 2006
Jul 14. 9 p.

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Melanoma

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Screening\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Internal Medicine\
Oncology\
Pathology\
Plastic Surgery\
Surgery

#### INTENDED USERS

Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide guidance on the management of patients with melanoma

#### TARGET POPULATION

Patients with pigmented skin lesions and skin melanoma

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Screening**

1.  Routine assessment of individuals with a known familial or otherwise
    increased risk of melanoma

2.  Population-based screening (considered but not recommended)

**Diagnosis/Evaluation**

1.  Dermatoscopy

2.  Histopathological diagnostic evaluation

    -   Pathology report documentation

3.  Sentinel node biopsy

    -   Pathological assessment of the sentinel node

    -   Optimal number of sections

    -   Optimal distance between sections

    -   Immunohistochemistry

4.  Supplemental tests for staging assessment

5.  American Joint Committee of Cancer (AJCC) staging system

**Management/Treatment**

1.  Excision margins of primary melanoma

    -   *In situ*

    -   Breslow thickness

2.  Pathological assessment of re-excised sections

3.  Adjuvant treatment

    -   Radiation therapy following lymph node dissection

    -   Systemic therapy in patients with a poor prognosis (not
        recommended outside a clinical trial)

4.  Treatment of metastases

    -   Clinical trials

    -   Dacarbazine

5.  Follow-up for primary melanoma

    -   Frequency based on Breslow thickness

#### MAJOR OUTCOMES CONSIDERED

-   Incidence of melanoma

-   Incidence of metastasis

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Relevant subjects were identified, and literature concerning each
subject was extensively reviewed by teams of two members of the
responsible committee. Each team prepared a report that was discussed in
plenary sessions of the committee.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Not Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not stated

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Relevant subjects were identified, and literature concerning each
subject was extensively reviewed by teams of two members of the
responsible committee. Each team prepared a report that was discussed in
plenary sessions of the committee.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Recommendations were formulated after extensive discussion within the
committee responsible for the guidelines preparation and after approval
of the Dutch Melanoma Working Group.

#### 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

Not stated

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Screening**

**Is screening for skin melanoma useful?**

The working group is of the opinion that routine checking for pigmented
lesions warrants recommendation in cases with a known familial increased
risk of melanoma. One check-up every 6 to 12 months is considered
sufficient.

According to the working group, increased attentiveness is advisable for
individuals with a combination of risk factors resulting in a
substantially increased risk of melanoma.

The working group is of the opinion that population-based screening for
melanoma is not warranted in the Netherlands.

**Diagnosis**

**Does dermatoscopy increase the accuracy of clinical diagnosis?**

Dermatoscopy has an established role in the clinical diagnosis of
pigmented skin disorders. Physicians who are unfamiliar with
dermatoscopy are advised to become proficient with the technique before
applying it.

**Pathological assessment of diagnostic excisions**

Each pigmented skin lesion removed should be submitted for
histopathological diagnostic evaluation.

The pathology request form should include at least the following
information: personal details, location of the lesion, reason for
removal (cosmetic versus diagnostic) and the excisional margin. For
excisions made for diagnostic purposes, the reason why malignancy was
suspected should be included (e.g., irregular macroscopic features,
changes over time, itching).

The pathology report should contain a conclusion statement which, for
cases of melanoma, should include at least the following information:

-   Anatomical location

-   Type of procedure (shave, punch, elliptical or incisional biopsy)

-   Excisional margin

-   Diagnosis of melanoma (including the histologic subtype, if
    possible)

-   Breslow thickness

-   Presence/absence of ulceration

-   Clark level

-   Presence/absence of microsatellitosis

-   Presence/absence of regression or partial regression

-   Completeness of the removal

If the diagnosis of melanoma is uncertain, the case should be presented
to a pathologist with special expertise in the diagnosis of melanocytic
tumours.

**Sentinel Node Procedure**

*What is the indication for sentinel node biopsy?*

According to the working group, sentinel node biopsy should be reserved
for patients who desire the most complete information possible regarding
their prognosis. This procedure is not considered part of standard
diagnostic evaluation. If sentinel node biopsy is proposed, the low risk
of complications, the rather high percentage of false-negative results,
and the possible increased incidence of in-transit metastases should be
considered.

*How should pathological assessment of the sentinel node be conducted?*

Intraoperative frozen section assessment of the sentinel node is
contraindicated in melanoma.

In addition to haematoxylin-eosin (HE) stained sections, evaluation of
the sentinel node requires immunostaining for S-100 and at least one
additional, more specific marker, preferably MART-1.

Assessment of more than one section of the sentinel node is necessary
for optimal detection of melanoma metastases. At this time, definitive
statements cannot be made regarding the optimal number of sections to
assess or the optimal distance between sections. The working group
advises that at least three sections from each paraffin block are
assessed, including immunohistochemistry of each section; however,
assessment of six sections is preferred, in accordance with the European
Organisation for Research and Treatment of Cancer (EORTC) guidelines.

The optimal distance between sections depends on the total number of
sections and varies between 50 microns for six sections and 150 microns
for three sections. Measuring the number and size of melanoma metastases
in the sentinel node is not necessary at this time, as confirmation of
the possible therapeutic relevance of these findings is pending.

The sentinel node should be fixed *in toto* and prepared completely for
microscopic histopathological evaluation.

**Supplemental Investigation**

*For localised melanoma (American Joint Committee of Cancer \[AJCC\]
stage I and II), does supplemental testing (other than sentinel node
evaluation) influence the prognosis?*

Supplemental tests for staging assessment are not routinely indicated
for patients with clinically localized melanoma. Supplemental testing
can be used when indicated, such as the use of lymph node ultrasound
when palpation of the lymph node regions yields inconclusive results.

**Treatment**

**What are the recommended margins for therapeutic re-excision of a
primary melanoma?**

The following margins of unaffected skin surrounding the biopsy are
recommended for the therapeutic re-excision of melanoma:

-   Melanoma *in situ*: 0.5 cm

-   Breslow thickness [\<]{.underline}2 mm: 1 cm

-   Breslow thickness \>2 mm: 2 cm

**Pathological Assessment of Re-excised Skin Sections**

-   Assessment of three blocks of scar tissue in re-excised sections of
    skin/subcutis is sufficient following complete excision of the
    melanoma.

-   Complete embedment of the scar tissue is required if the melanoma is
    not removed completely during diagnostic excision and residual
    tumour is revealed by the resection margin analysis of the
    re-excision.

-   Pigmented lesions and other focal abnormalities should always be
    evaluated histologically.

**Adjuvant Treatment**

**Is adjuvant radiation therapy indicated following lymph node
dissection?**

Adjuvant radiation therapy is not considered standard treatment
following lymph node dissection. Whether radiation therapy is applied
and how it is applied depends on the prognosis and the risk of recurrent
disease in the area of the removed lymph nodes.

**Is there a systemic adjuvant therapy that has proven efficacy in
patients with prognostically unfavourable characteristics?**

Systemic adjuvant treatment of patients with melanoma is not recommended
outside the context of a clinical trial. This also applies to adjuvant
treatment with interferon a (IFNa).

**Treatment of Metastases**

**Which systemic therapy is the treatment of choice for melanoma with
distant metastases?**

Patients with metastatic melanoma are preferably treated in a clinical
trial. If treatment outside the context of a clinical trial is to be
considered, there is no better alternative to dacarbazine (DTIC).

**Follow-Up**

**What is adequate follow-up for primary melanoma?**

Breslow thickness [\<]{.underline}1 mm:

-   A single check-up 1 month after treatment for primary melanoma,
    providing the patient with the opportunity to ask questions and
    learn self-checking techniques. It should be explained to the
    patient that additional check-ups do not improve the chance of cure,
    but that an appointment can always be made at short notice if
    symptoms occur.

-   If desired, additional check-ups can be scheduled for counselling,
    checking one\'s own work, educational purposes, or scientific
    research.

-   The frequency and extent of evaluation is then determined by need.

Breslow thickness \>1 mm:

-   Year 1: check-up once every 3 months

-   Year 2: check-up once every 4 months

-   Years 3 to 5: check-up once every 6 months

Breslow thickness \>2 mm:

-   Same as Breslow thickness \> 1 mm plus annual check-ups years 6 to
    10.

Supplemental tests as indicated.

**Staging**

**Which staging system should be used for melanoma in the Netherlands?**

The working group is of the opinion that the American Joint Committee of
Cancer (AJCC) staging system --- unabridged and unmodified --- should be
adopted in the Netherlands.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Improved quality of care in patients with melanoma

-   Better results from treatment

-   Decreased metastases

-   Decreased mortality

#### POTENTIAL HARMS

If sentinel node biopsy is proposed, the low risk of complications, the
rather high percentage of false-negative results, and the possible
increased incidence of in-transit metastases should be considered.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Intraoperative frozen section assessment of the sentinel node is
contraindicated in melanoma.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Foreign Language Translations\
Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Dutch Working Group on Melanoma. Skin melanoma. Utrecht, The
Netherlands: Association of Comprehensive Cancer Centres (ACCC); 2006
Jul 14. 9 p.

#### ADAPTATION

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

#### DATE RELEASED

2006 Jul

#### GUIDELINE DEVELOPER(S)

Association of Comprehensive Cancer Centres - Disease Specific Society

#### SOURCE(S) OF FUNDING

Association of Comprehensive Cancer Centres

#### GUIDELINE COMMITTEE

Dutch Working Group on Melanoma

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in English and Dutch from the [Association
of Comprehensive Cancer Centres Web
site](http://www.oncoline.nl/index.php?pagina=/richtlijn/item/pagina.php&richtlijn_id=476).

Print copies: Available from the Association of Comprehensive Cancer
Centres PO Box 19001, 3501 DA Utrecht, The Netherlands

#### AVAILABILITY OF COMPANION DOCUMENTS

A version of the guideline for Personal Digital Assistants (PDAs) is
also available at the [Association of Comprehensive Cancer Centres Web
site](http://www.oncoline.nl/index.php?pagina=/richtlijn/item/pagina.php&richtlijn_id=476).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on May 8, 2008. The
information was verified by the guideline developer on July 1, 2008.

#### COPYRIGHT STATEMENT

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

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008