一项入组900余例厚度超过2 mm的皮肤黑色素瘤患者的随机对照试验显示，手术切缘为2 cm者的5年总生存率和无复发生存率均与切缘为4 cm者相似，提示采用2 cm的切缘就足够安全了。
对厚度超过2 mm的皮肤黑色素瘤患者行切除手术时应选择多大的切缘，由于缺乏相关比较数据而一直存在争议，但多数国际性指南建议采用2~3 cm的切缘。一般而言，临床医生需要在手术难度更大的广泛切除与生存率较低的小范围切除之间进行权衡。
瑞典黑色素瘤研究组和丹麦黑色素瘤组共同开展了本项研究，在1992年1月~2004年5月期间招募年龄≤75岁的原发局限性皮肤黑色素瘤成年患者，肿瘤厚度＞2 mm，位于躯干或四肢。随机分为2 cm切缘组和4 cm切缘组。
Peter Gillgren医生
瑞典斯德哥尔摩卡罗林斯卡研究所Söder医院的Peter Gillgren医生及其同事报告，中位随访6.7年，2 cm切缘组465例患者的5年总生存率为65%，与4 cm切缘组471例患者相同；两组的5年无复发生存率均为56%，10年生存率均为50%。
2 cm切缘不仅生存率与4 cm切缘相似，而且更有利于缝合皮肤而不需要皮肤移植或皮瓣。2 cm切缘组和4 cm切缘组的一期缝合率分别为69%和37%，两组分别有12%和47%的患者接受了伤口皮肤移植，分别有4%和6%的患者使用了手术皮瓣。
虽然存在一定局限性，例如15%的患者违反了研究协议、研究原本计划招募2,000例患者，但Gillgren医生称该研究仍是迄今该领域的最大规模随机对照试验，为黑色素瘤手术切缘的选择提供了最佳证据。他们建议对目前所有的关于厚度＞2 mm的皮肤黑色素瘤随机试验进行Meta分析。
John F. Thompson医生和David W. Ollila医生在随刊述评中重申，理想的手术切缘仍不明确。上述研究结果虽然提供了重要信息，但还需要弄清2 cm切缘是否优于1 cm切缘，而且有一项旨在解决这一问题的大规模多中心研究已在计划中。
Thompson医生和Ollila医生报告称无相关利益冲突。这项研究由瑞典肿瘤学会和斯德哥尔摩肿瘤学会资助。研究作者报告无相关利益冲突。
相关英文论文摘要：
2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial
Background Optimum surgical resection margins for patients with clinical stage IIA—C cutaneous melanoma thicker than 2 mm are controversial. The aim of the study was to test whether survival was different for a wide local excision margin of 2 cm compared with a 4-cm excision margin.
Methods We undertook a randomised controlled trial in nine European centres. Patients with cutaneous melanoma thicker than 2 mm, at clinical stage IIA—C, were allocated to have either a 2-cm or a 4-cm surgical resection margin. Patients were randomised in a 1:1 allocation to one of the two groups and stratified by geographic region. Randomisation was done by sealed envelope or by computer generated lists with permuted blocks. Our primary endpoint was overall survival. The trial was not masked at any stage. Analyses were by intention to treat. Adverse events were not systematically recorded. The study is registered with ClinicalTrials.gov, number NCT01183936.
Findings 936 patients were enrolled from Jan 22, 1992, to May 19, 2004; 465 were randomly allocated to treatment with a 2-cm resection margin, and 471 to receive treatment with a 4-cm resection margin. One patient in each group was lost to follow-up but included in the analysis. After a median follow-up of 6·7 years (IQR 4·3—9·5) 181 patients in the 2-cm margin group and 177 in the 4-cm group had died (hazard ratio 1·05, 95% CI 0·85—1·29; p=0.64). 5-year overall survival was 65% (95% CI 60—69) in the 2-cm group and 65% (40—70) in the 4-cm group (p=0·69).
Interpretation Our findings suggest that a 2-cm resection margin is sufficient and safe for patients with cutaneous melanoma thicker than 2 mm.
Funding Swedish Cancer Society and Stockholm Cancer Society.
英文论文链接：https://www.lancet.com/journals/lancet/article/PIIS0140-6736%2811%2961546-8/fulltext
