Intervention Review

Surgical excision margins for primary cutaneous melanoma

  1. Michael J Sladden1,*,
  2. Charles Balch2,
  3. David A Barzilai3,
  4. Daniel Berg4,
  5. Anatoli Freiman5,
  6. Teenah Handiside6,
  7. Sally Hollis6,
  8. Marko B Lens7,
  9. John F Thompson8

Editorial Group: Cochrane Skin Group

Published Online: 20 JAN 2010

Assessed as up-to-date: 2 AUG 2009

DOI: 10.1002/14651858.CD004835.pub2

Database Title

Additional Information

How to Cite

Sladden MJ, Balch C, Barzilai DA, Berg D, Freiman A, Handiside T, Hollis S, Lens MB, Thompson JF. Surgical excision margins for primary cutaneous melanoma. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD004835. DOI: 10.1002/14651858.CD004835.pub2.

Author Information

  1. 1

    University of Tasmania, Department of Medicine, Launceston, Tasmania, Australia

  2. 2

    Johns Hopkins Medical Institutions, Surgery, Baltimore, Maryland, USA

  3. 3

    Case Western Reserve University, Cleveland, USA

  4. 4

    University of Washington Medical Center, Department of Medicine/Dermatology, Seattle, Washington, USA

  5. 5

    University of Toronto, Division of Dermatology, Toronto, ON, Canada

  6. 6

    University of Nottingham, c/o Cochrane Skin Group, Nottingham, UK

  7. 7

    King's College, Genetic Epidemiology Unit, London, UK

  8. 8

    University of Sydney, The Sydney Melanoma Unit, Sydney, Australia

*Michael J Sladden, Department of Medicine, University of Tasmania, Launceston General Hospital, Launceston, Tasmania, 7250, Australia. m.sladden@doctors.org.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 JAN 2010

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 methods

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.

The summary estimate for overall survival favoured wide excision by a small degree [Hazard Ratio 1.04; 95% confidence interval 0.95 to 1.15; P = 0.40], but the result was not significantly different. This result is compatible with both a 5% relative reduction in overall mortality favouring narrower excision and a 15% relative reduction in overall mortality favouring wider excision. Therefore, a small (but potentially important) difference in overall survival between wide and narrow excision margins cannot be confidently ruled out.

The summary estimate for recurrence free survival favoured wide excision [Hazard Ratio 1.13; P = 0.06; 95% confidence interval 0.99 to 1.28] but again the result did not reach statistical significance (P < 0.05 level).

Current randomised trial evidence is insufficient to address optimal excision margins for primary cutaneous melanoma.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Surgical excision margins for primary cutaneous melanoma

Whilst melanoma accounts for only 5% of skin cancers, it is important because it is the cause of 75% of all skin cancer deaths. For primary cutaneous melanoma, standard treatment is complete surgical removal of the melanoma with a safety margin some distance from the visible edges of the primary tumour. The purpose of the safety margin is to remove both the primary tumour and any melanoma cells that might have spread into the surrounding skin. However, the optimal width of the safety (excision) margin remains unclear.

This systematic review summarises the evidence about how much tissue (safety margin) should be removed for primary cutaneous melanoma (skin cancer). Excision margins are important because there could be a trade-off between a better cosmetic result but poorer long-term survival if excision margins become too narrow.

It is important to note that for the purposes of this review we consider only invasive melanoma - that has invaded into the deeper layer of the skin (dermis) - and not melanoma-in-situ where the melanoma cells are confined to the outermost layer of the skin (epidermis).

We found five published randomised trials, none of which showed a statistically significant difference in overall survival for patients who had either narrow or wide removal of the melanoma and surrounding tissue.  Similarly, our meta-analysis showed there was no statistically significant difference in overall survival between the two groups treated with either narrow or wide excision. 

The summary estimate for overall survival favoured wide excision by a small degree, but the result was not significantly different. This result is compatible with both a 5% relative reduction in overall mortality favouring narrower excision and a 15% relative reduction in overall mortality favouring wider excision. 

Current randomised trial evidence is insufficient to address optimal excision margins for primary cutaneous melanoma.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

原發性皮膚黑色素瘤的手術切除範圍

皮膚黑色素細胞瘤佔皮膚癌死亡的75% 。標準的治療方法為從原發腫瘤的邊界取一段安全範圍做手術切除。取這段安全範圍的目的，是要確保能夠完全移除原發腫瘤，同時移除可能蔓延在病灶周圍皮膚的任何黑色素細胞瘤細胞。切除的範圍很重要，因為如果範圍取的太小，雖然可能達到較好的美觀性但卻造成較差的長期存活率。最適當的切除範圍應該多大仍然不確定。因此值得做一個系統性的回顧。

目標

評估對於原發性皮膚黑色素瘤，不同切除範圍的效果。

搜尋策略

於2009年8月，我們從Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 3, 2009), MEDLINE, EMBASE, LILACS, 和其他資料庫包括Ongoing Trials Registers，搜尋相關聯的隨機試驗。

選擇標準

我們選取所有的隨機對照試驗，關於手術切除黑色素瘤不同範圍的比較。

資料收集與分析

我們評估試驗的品質，並匯整分析關於存活率和復發率的資料。我們也從試驗裡收集了副怍用的資訊。

主要結論

我們找到了5篇試驗。有1633位參予者屬於接受窄的切除範圍，1644位參予者屬於接受寬的切除範圍。窄的範圍指1到2公分; 寬的範圍指3到5公分。平均的追蹤時間從5年到16年不等。

作者結論

這篇系統性回顧，整合了關於原發性皮膚黑色素瘤切除範圍大小的證據。不論是5篇已發表的試驗，或者是這篇整合分析的結果，都顯示寬範圍切除比上窄範圍切除，對於整體存活率而言，沒有統計上的差異。整合的結果認為整體存活率在寬範圍切除有比較好一點[危險值 1.04; 95% 信賴區間 0.95 到 1.15; P = 0.40]，但此結果沒有達到顯著差異。這個結果和以下結果相吻合，於窄範圍切除有5% 相對降低的整體死亡率，於寬範圍切除有15% 相對降低的整體死亡率。因此，這一小部分 (但潛在重要) 的差異，存在於寬範圍和窄範圍切除間的整體存活率的差異，不能確信地排除。整合的結果認為寬範圍切除的無復發存活率較好[危險值 1.13; P = 0.06; 95% 信賴區間 0.99 到 1.28]，但再一次地，結果沒有達到顯著統計意義 (P <0.05 標準) 。目前的隨機試驗的證據不足以歸納出原發性皮膚黑色素瘤最適當的切除範圍。

翻譯人

本摘要由馬偕醫院楊兆傑翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

原發性皮膚黑色素瘤的手術切除範圍: 黑色素瘤只佔皮膚癌的5% ，但是卻很重要，因為它佔所有皮膚癌死亡的75% 。對於原發性皮膚黑色素瘤，標準的治療方法為從原發腫瘤的可見邊界取一段安全範圍做手術完全切除。取這段安全範圍的目的，是要確保能夠移除原發腫瘤，同時移除可能蔓延在病灶周圍皮膚的任何黑色素瘤細胞。然而，最適當的安全 (切除) 範圍仍然不清楚。這一篇系統性回顧，整合了關於原發性皮膚黑色素瘤 (皮膚癌) 應該拿掉多少組織 (安全範圍) 的證據。切除的範圍很重要，因為如果範圍取的太小，雖然可能達到較好的美觀性但卻造成較差的長期存活率。特別要強調為了這一篇回顧的目的，我們只考慮侵襲性的黑色素瘤那些已經侵犯到皮膚深層 (真皮) 的腫瘤而非黑色素細胞原位癌，其黑色素癌細胞仍侷限於皮膚的最底層 (表皮) 。我們找到了5篇已發表的隨機試驗，沒有一篇顯示，對於黑色素瘤病人接受窄範圍切除和寬範圍切除，其整體存活率在統計上有顯著差義。相類似地，我們的整合分析顯示，對於窄範圍切除和寬範圍切除兩群，在整體存活率上沒有統計的顯著差異。整合的結果認為整體存活率在寬範圍切除有比較好一點，但此結果沒有達到顯著差異。這個結果和以下結果相吻合，於窄範圍切除有5% 相對降低的整體死亡率，於寬範圍切除有15% 相對降低的整體死亡率。目前的隨機試驗的證據不足以歸納出原發性皮膚黑色素瘤最適當的切除範圍。

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