Sladden Michael J, Balch Charles, Barzilai David A, Berg Daniel, Freiman Anatoli, Handiside Teenah, Hollis Sally, Lens Marko B, Thompson John F
Department of Medicine, University of Tasmania, Launceston General Hospital, Launceston, Tasmania, Australia, 7250.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD004835. doi: 10.1002/14651858.CD004835.pub2.
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.
To assess the effects of different excision margins for primary cutaneous melanoma.
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.
We considered all randomised controlled trials (RCTs) of surgical excision of melanoma comparing different width excision margins.
We assessed trial quality, and extracted and analysed data on survival and recurrence. We collected adverse effects information from included trials.
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.
皮肤黑色素瘤占皮肤癌死亡病例的75%。标准治疗方法是手术切除，切除范围需距原发肿瘤边界一定距离的安全切缘。安全切缘的目的是切除完整的原发肿瘤以及任何可能已扩散至周围皮肤的黑色素瘤细胞。切缘很重要，因为如果切缘过窄，可能在获得更好的美容效果但长期生存率较低之间存在权衡。最佳切缘宽度仍不明确。这种不确定性值得进行系统评价。
评估不同切缘宽度对原发性皮肤黑色素瘤的影响。
2009年8月，我们在Cochrane皮肤组专业注册库、Cochrane图书馆（2009年第3期）中的Cochrane对照试验中央注册库（CENTRAL）、MEDLINE、EMBASE、LILACS以及其他数据库（包括正在进行的试验注册库）中检索相关随机试验。
我们纳入了所有比较不同宽度切缘的黑色素瘤手术切除随机对照试验（RCT）。
我们评估了试验质量，并提取和分析了生存及复发数据。我们从纳入试验中收集了不良反应信息。
我们确定了5项试验。窄切缘组有1633名参与者，宽切缘组有1664名参与者。窄切缘定义为1至2厘米；宽切缘为3至5厘米。中位随访时间为5至16年。
本系统评价总结了关于原发性皮肤黑色素瘤切缘宽度的证据。五项已发表的试验以及我们的荟萃分析均未显示窄切缘或宽切缘在总生存方面存在统计学显著差异。总生存的汇总估计值略微倾向于宽切缘[风险比1.04；95%置信区间0.95至1.15；P = 0.40]，但结果无显著差异。该结果既与窄切缘使总死亡率相对降低5%相符，也与宽切缘使总死亡率相对降低15%相符。因此，不能排除宽切缘和窄切缘在总生存方面存在微小（但可能很重要）差异的可能性。无复发生存的汇总估计值倾向于宽切缘[风险比1.13；P = 0.06；95%置信区间0.99至1.28]，但结果同样未达到统计学显著性（P < 0.05水平）。目前的随机试验证据不足以确定原发性皮肤黑色素瘤的最佳切缘宽度。
