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Surgical excision margins for primary cutaneous melanoma

Clinical Summary

Melanoma is an increasingly common skin cancer. In 2000, the World Health Organisation estimated that there were more than 130,000 cases and 37,000 deaths annually. Melanoma is usually diagnosed before the cancer has spread to other parts of the body, and the only effective treatment known at the moment for primary cutaneous melanoma is surgery. There current uncertainty, however, about how extensive this surgery should be. How much apparently healthy tissue should be removed along with the tumour? Mike Sladden, a dermatologist from Tasmania in Australia, and colleagues from around the world have examined the evidence from randomised trials and present this in a new Cochrane review.

The size of the excision margins is important because wider margins might lead to a greater chance of surviving the melanoma but at the expense of worse cosmetic results or adverse effects from the more extensive surgery. A systematic review might be able to identify an optimal width that strikes a balance between the difference outcomes, or, at least, present the current evidence in a clear way to enable patients and their doctors to make an informed choice.

The authors found that the current national guidelines from several countries provide some consistent generalisations regarding the width of excision margins, but offer slightly different advice. The review contains a table comparing the guidance. This table can also be found in this Journal Club’s slideshow.

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The review found five published randomised trials, with a total of 3,400 participants. Two of the trials compared 1 cm versus 3 cm margins, two compared 2 cm versus 5 cm and one compared 2 cm versus 4 cm. In a future update of the review, this last trial will be joined by the results of an ongoing study identified by the Cochrane reviewers, which has randomised about 900 patients.

None of the five trials detected a statistically significant difference in overall survival or recurrence free survival between the two types of surgery on their own. The results remained non-statistically significant when the findings from all five were combined in a meta-analysis. This meta-analysis used the hazard ratios from each trial. These provide an estimate of the difference between the interventions over time, rather than simply at a specific time point, and the evidence comes from follow-up of patients through the first decade after treatment.  The overall estimate for death from any cause was a hazard ratio of 1.04 (95% confidence intervals 0.95 to 1.15). This is compatible with a 5% relative reduction in deaths favouring narrower excision or a 15% relative reduction favouring wider excision.

Therefore, the currently available randomised evidence is insufficient to identify the optimal excision margins for patients with primary cutaneous melanoma. It does not rule out a small difference in outcome between the different margins or prove that there is no difference. Resolving this uncertainty will require much more randomised evidence, either from a single very large trial or from a series of trials which could be combined in future meta-analyses; for example, in future versions of this review.

In the meantime, this Cochrane review provides an up-to-date summary of the available evidence. It should be considered alongside national guidelines and local policy when determining the extent of surgery for this increasingly common and life-threatening cancer

Read the Paper

Surgical excision margins for primary cutaneous melanoma (Review)
Sladden MJ, Balch C, Barzilai DA, Berg D, Freiman A, Handiside T, Hollis S, Lens MB, Thompson JF

Background: Cutaneous melanoma accounts for 75% of skin cancer deaths. Standard treatment is surgical excision with a safety margin some distance from the borders of the primary tumour. The purpose of the safety margin is to remove both the complete primary tumour and any melanoma cells that might have spread into the surrounding skin.
Excision margins are important because there could be trade-off between a better cosmetic result but poorer long-term survival if margins become too narrow. The optimal width of excision margins remains unclear. This uncertainty warrants systematic review.

Objectives: To assess the effects of different excision margins for primary cutaneous melanoma.

Search Strategy: In August 2009 we searched for relevant randomised trials in the Cochrane Skin Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 3, 2009), MEDLINE, EMBASE, LILACS, and other databases including Ongoing Trials Registers.

Selection Criteria: We considered all randomised controlled trials (RCTs) of surgical excision of melanoma comparing different width excision margins.

Data collection and analysis: We assessed trial quality, and extracted and analysed data on survival and recurrence. We collected adverse effects information from included trials.

Main results: We identified five trials. There were 1633 participants in the narrow excision margin group and 1664 in the wide excision margin group. Narrow margin definition ranged from 1 to 2 cm; wide margins ranged from 3 to 5 cm. Median follow-up ranged from 5 to 16 years.

Authors' conclusions: This systematic review summarises the evidence regarding width of excision margins for primary cutaneous melanoma. None of the five published trials, nor our meta-analysis, showed a statistically significant difference in overall survival between narrow or wide excision.

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Questions and Answers

Q. Were you able to distinguish which type of melanoma in each case? i.e. SSM, NM. etc?

A. No, this information was not available in the primary studies.

Q. When a confident experienced clinician is sure a lesion is a melanoma; given the questionable benefit of sentinel lymph node biopsy is there a deleterious effect from proceeding straight to a 10mm excision to save the patient from 2 distressing procedures?

A. Great question. I think that most guidelines say 'excise with 2mm margin initially' so one has the option of performing SLNB. I agree there is no proven overall survival benefit from SLNB and I personally would not have SLNB. I know of no evidence that proceeding straight to a 10mm excision has any deleterious effect (I can think of no biological reason why it should cause problems). Indeed, in Thomas's study, some patients had an initial 10mm excision before randomisation, and those randomised to 1cm margins (of course) needed to further excision. My personal view is that if a patient is not interested in SLNB, proceeding straight to 10mm margins is fine (or 5mm for m-in-s; or 1-2 cm for deeper melanomas). Hope this helps.

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Author Profile

Author

Dr Michael Sladden is a Visiting Medical Officer in Dermatology at Launceston General Hospital, Tasmania, and Clinical Associate Professor in the Department of Medicine (Dermatology) at the University of Tasmania.

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As Clinical Associate Professor at the University of Tasmania, Dr Sladden regularly teaches and supervises medical students, and teaches dermatology to GP registrars and GPs in Tasmania. He has a Research Masters degree in epidemiology and has training and expertise in epidemiology, public health, evidence-based medicine, teaching and research.

Dr Sladden is interested in promoting evidence-based dermatology at both a national and an international level, including continuing involvement with the Cochrane Collaboration and further developing the use of ‘Critically Appraised Topics’ (CATs). Dr Sladden is a member of the Australian Cancer Network committee formulating Clinical Practice Guidelines for Cutaneous Melanoma, and has approximately 50 publications in peer-reviewed journals to his name, including two Cochrane Reviews.

Dr Sladden represents the group of authors who collaborated on "Surgical excision margins for primary cutaneous melanoma". The full author group is as follows: Michael J Sladden, Charles Balch, David A Barzilai, Daniel Berg, Anatoli Freiman, Teenah Handiside, Sally Hollis, Marko B Lens, John F Thompson.

Discussion points: a critical appraisal

What are the questions you should be asking as you read this paper? – find out here.