Adjuvant radiation for malignant melanoma


Guideline Developer(s)

CancerControl Alberta

Date Released

2012 Mar

Evidence Supporting the Recommendations

References Supporting the Recommendations

National Comprehensive Cancer Network (NCCN). Melanoma guidelines. Fort Washington (PA): National Comprehensive Cancer Network (NCCN); 2009.

Type of Evidence Supporting the Recommendations

The recommendations are partially supported by a practice guideline (see the "Major Recommendations" field).

Implementation of the Guideline

Description of Implementation Strategy
  • Present the guideline at the local and provincial tumour team meetings and weekly rounds.
  • Post the guideline on the Alberta Health Services website.
  • Send an electronic notification of the new guideline to all members of Alberta Health Services, Cancer Care.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate use of adjuvant radiation for malignant melanoma—several non-randomized studies have suggested that postoperative radiation to the neck or axilla after radical lymph node dissection decreases regional recurrence rates in node-positive patients.

Potential Harms

Radiation should not be given concurrently with interferon. Interferon may act as a radiosensitizer, and patients receiving both may experience increased toxicities.

Rating Scheme for the Strength of the Recommendations

Not applicable

Qualifying Statements

Qualifying Statements

The recommendations contained in this guideline are a consensus of the Alberta Provincial Cutaneous Tumour Team and are a synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care.

Methodology

Methods Used to Collect/Select the Evidence

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

Research Questions

Specific research questions to be addressed by the guideline document were formulated by the guideline lead(s) and Knowledge Management (KM) Specialist using the PICO question format (patient or population, intervention, comparisons, outcomes).

Guideline Question

Should adjuvant radiation therapy be offered to patients who have been rendered disease-free following the resection of cutaneous melanomas and who are at high risk for subsequent recurrence?

Search Strategy

The MEDLINE (1966 through January 2011), CINAHL, Cochrane, ASCO Abstracts and proceedings, and CANCERLIT databases were searched. The search included practice guidelines, systematic reviews, meta-analyses, randomized controlled trials, and clinical trials. Search terms included: radiation or adjuvant radiation and malignant melanoma.

For the 2012 update of the guideline, PubMed was searched for evidence on radiation therapy in cutaneous melanoma. The search term "melanoma" was used and results were limited to clinical trials, published between January 2011 and January 2012. Citations were hand-searched for studies pertaining to radiation therapy, resulting in no additional clinical trials. Updates to the National Comprehensive Cancer Network guideline (2012) on melanoma were cross referenced with this guideline as well. Following a review of the evidence by the Alberta Provincial Cutaneous Tumour Team, no changes to the recommendations were made.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Expert Consensus

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Systematic Review with Evidence Tables

Description of the Methods Used to Analyze the Evidence

Evidence was selected and reviewed by a working group comprised of members from the Alberta Provincial Cutaneous Tumour Team and a Knowledge Management (KM) Specialist from the Guideline Utilization Resource Unit (GURU). A detailed description of the methodology followed during the guideline development process can be found in the Guideline Utilization Resource Unit Handbook (see the "Availability of Companion Documents" field).

Evidence Tables

Evidence tables containing the first author, year of publication, patient group/stage of disease, methodology, and main outcomes of interest are assembled using the studies identified in the literature search. Existing guidelines on the topic are assessed by the KM Specialist using portions of the Appraisal of Guidelines Research and Evaluation (AGREE) II instrument (http://www.agreetrust.org) and those meeting the minimum requirements are included in the evidence document. Due to limited resources, GURU does not regularly employ the use of multiple reviewers to rank the level of evidence; rather, the methodology portion of the evidence table contains the pertinent information required for the reader to judge for himself the quality of the studies.

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

Formulating Recommendations

The working group members formulated the guideline recommendations based on the evidence synthesized by the Knowledge Management (KM) Specialist during the planning process, blended with expert clinical interpretation of the evidence. As detailed in the Guideline Utilization Resource Unit Handbook (see the "Availability of Companion Documents" field), the working group members may decide to adopt the recommendations of another institution without any revisions, adapt the recommendations of another institution or institutions to better reflect local practices, or develop their own set of recommendations by adapting some, but not all, recommendations from different guidelines.

The degree to which a recommendation is based on expert opinion of the working group and/or the Provincial Tumour Team members is explicitly stated in the guideline recommendations. Similar to the American Society of Clinical Oncology (ASCO) methodology for formulating guideline recommendations, the Guideline Utilization Resource Unit (GURU) does not use formal rating schemes for describing the strength of the recommendations, but rather describes, in conventional and explicit language, the type and quality of the research and existing guidelines that were taken into consideration when formulating the recommendations.

Cost Analysis

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

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

This guideline was reviewed and endorsed by the Alberta Provincial Cutaneous Tumour Team.

When the draft guideline document is completed, revised, and reviewed by the Knowledge Management Specialist and the working group members, it is sent to all members of the Provincial Tumour Team for review and comment. The working group members then make final revisions to the document based on the received feedback, as appropriate. Once the guideline is finalized, it is officially endorsed by the Provincial Tumour Team Lead and the Executive Director of Provincial Tumour Programs.

Identifying Information and Availability

Bibliographic Source(s)

Alberta Provincial Cutaneous Tumour Team. Adjuvant radiation for malignant melanoma. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2012 Mar. 7 p. (Clinical practice guideline; no. CU-003).  [28 references]

Adaptation

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

Source(s) of Funding

Alberta Health Services, Cancer Care

Guideline Committee

Alberta Provincial Cutaneous Tumour Team

Composition of Group That Authored the Guideline

Not stated

Financial Disclosures/Conflicts of Interest

Participation of members of the Alberta Provincial Cutaneous Tumour Team in the development of this guideline has been voluntary and the authors have not been remunerated for their contributions. There was no direct industry involvement in the development or dissemination of this guideline. Alberta Health Services, Cancer Care recognizes that although industry support of research, education and other areas is necessary in order to advance patient care, such support may lead to potential conflicts of interest. Some members of the Alberta Provincial Cutaneous Tumour Team are involved in research funded by industry or have other such potential conflicts of interest. However the developers of this guideline are satisfied it was developed in an unbiased manner.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Alberta Health Services Web site.

Availability of Companion Documents

The following is available:

  • Guideline utilization resource unit handbook. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2011 Dec. 5 p. Electronic copies: Available in Portable Document Format (PDF) from the Alberta Health Services Web site.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on December 11, 2012. The information was verified by the guideline developer on January 23, 2013.

Copyright Statement

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

Scope

Disease/Condition(s)

Malignant melanoma

Guideline Category

Management
Treatment

Clinical Specialty

Dermatology
Oncology
Radiation Oncology

Intended Users

Physicians

Guideline Objective(s)

To evaluate if adjuvant radiation therapy should be offered to patients who have been rendered disease-free following the resection of cutaneous melanomas and who are at high risk for subsequent recurrence

Target Population

Adults over the age of 18 years with malignant melanoma

Note: Different principles may apply to pediatric patients.

Interventions and Practices Considered

Adjuvant post-operative radiation therapy

Major Outcomes Considered
  • Disease control/recurrence rates
  • Disease-specific, disease-free, and distant metastases-free survival rates

Recommendations

Major Recommendations
  • Most patients with in-situ or early-stage melanoma (Stage 0; Stage 1A/B; Stage II, 1 mm thick with ulceration or Clark level IV, V or >1 mm thick, any characteristic; and Stage III, sentinel node positive):
    • There is no recommendation for the use of adjuvant radiation therapy, as most of these patients will be cured by primary excision alone (National Comprehensive Cancer Network [NCCN], 2009).
    • Post-operative radiotherapy may be used after close or positive margins where further excision is not practical or possible, inoperative lentigo maligna, rapid or multiple recurrences or extensive perineural spread (as seen with Desmoplastic melanoma).
  • Patients with Stage IIIC or Stage IV disease should be referred for the consideration of adjuvant radiation therapy to improve local and regional control of their disease (NCCN, 2009)
    • Stage IIIC with multiple nodes involved or extranodal extension: consider radiation therapy to nodal basin.
    • Stage III in transit: consider radiation therapy.
    • Stage IV metastatic: if disseminated (unresectable) with brain metastases, consider radiation for symptomatic patients.
  • Consider the following for patients with recurrence (NCCN, 2009):
    • Recurrence (true local scar): base treatment on stage of recurrence.
    • Recurrence (local, satellitosis, and/or in-transit): consider radiation therapy.
    • Recurrence (nodal): consider adjuvant radiation therapy.
    • Recurrence (distant): if disseminated (unresectable) with brain metastases, consider radiation for symptomatic patients.
  • If interferon is to be part of the treatment regimen:
    • Radiation should not be given concurrently.
    • Interferon may act as a radiosensitizer, and patients receiving both may experience increased toxicities.
    • Radiation therapy may be delayed until completion of the induction phase of interferon administration.
Clinical Algorithm(s)

None provided

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need

Getting Better
Living with Illness

IOM Domain

Effectiveness

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