Wide versus narrow excision margins for high-risk, primary cutaneous melanomas: long-term follow-up of survival in a randomised trial
Wide versus narrow excision margins for high-risk, primary cutaneous melanomas: long-term follow-up of survival in a randomised trial
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DOI：
10.1016/s1470-2045(15)00482-9
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发表时间：
2016-02-01
期刊：
影响因子：
51.1
通讯作者：
Thomas, J. Meirion
中科院分区：
文献类型：
--
作者：
Hayes, Andrew J.;Maynard, Lauren;Thomas, J. Meirion
背景对于厚度大于2 mm的皮肤黑色素瘤是否需要切缘是有争议的。在中位随访5年时，我们先前发表的厚皮肤黑色素瘤患者窄切缘（1 cm）与宽切缘（3 cm）的随机试验结果显示，窄切缘与局部复发频率增加相关，但总生存率无显著差异。我们现在报告的长期生存分析，trial.Methods我们做了一个随机的，开放标签的多中心试验，在59家医院-57在英国，一个在波兰，一个在南非。在躯干或四肢（不包括手掌或足底）上具有大于2 mm Breslow厚度的一个原发性局部皮肤黑色素瘤的患者被随机分配（1：1）接受手术，在初始手术后切除1 cm或3 cm切缘。使用随机排列区组生成随机化列表，并按中心和初始手术程度分层。该分析的终点是总生存期和黑色素瘤特异性生存期。在意向治疗人群中进行分析。结果1992年12月16日至2001年5月22日期间，我们随机分配900例患者进行手术，切除边缘为1 cm（n=453）或3 cm（n=447）。在中位随访8.8年（106个月[IQR 76-135]）时，494例患者死亡，其中359例死亡归因于黑色素瘤。1 cm组中有194例死亡归因于黑色素瘤，而3 cm组中有165例死亡归因于黑色素瘤（未校正的风险比[HR] 1.24 [95% CI 1.01-1.53]; p=0.041）。尽管1 cm组的总体死亡人数高于3 cm组（253 vs 241），但差异不显著（未校正HR 1.14 [95% CI 0.96-1.36]; p=0.14）。手术并发症的报道，在35例（8%）患者在1厘米切除边缘组和65例（15%）患者在3 cm group.Interpretation我们的研究结果表明，1厘米切除边缘是不够的皮肤黑色素瘤Breslow厚度大于2毫米的躯干和四肢。目前的指南建议厚度大于2 mm的黑色素瘤的边缘为2 cm，但厚度较薄的黑色素瘤的边缘仅为1 cm。对于较薄且预后不良的黑色素瘤，1cm切缘的适当性应在未来的随机研究中予以讨论。版权所有（C）海耶斯等人。开放获取文章根据CC BY的条款分发。
Background The necessary margin of excision for cutaneous melanomas greater than 2 mm in thickness is controversial. At a median follow-up of 5 years, findings from our previously published randomised trial of narrow (1 cm) versus wide (3 cm) excision margins in patients with thick cutaneous melanomas showed that narrow margins were associated with an increased frequency of locoregional relapse, but no significant difference in overall survival was apparent. We now report a long-term survival analysis of that trial.Methods We did a randomised, open-label multicentre trial in 59 hospitals-57 in the UK, one in Poland, and one in South Africa. Patients with one primary localised cutaneous melanoma greater than 2 mm in Breslow thickness on the trunk or limbs (excluding palms or soles) were randomly assigned (1:1) centrally to receive surgery with either a 1 cm or 3 cm excision margin following an initial surgery. The randomisation lists were generated with random permuted blocks and stratified by centre and extent of initial surgery. The endpoints of this analysis were overall survival and melanoma-specific survival. Analyses were done in the intention-to-treat population. This trial was not registered because it predated mandatory trial registration.Findings Between Dec 16, 1992, and May 22, 2001, we randomly assigned 900 patients to surgery with either a 1 cm excision margin (n=453) or a 3 cm excision margin (n=447). At a median follow-up of 8.8 years (106 months [IQR 76-135], 494 patients had died, with 359 of these deaths attributed to melanoma. 194 deaths were attributed to melanoma in the 1 cm group compared with 165 in the 3 cm group (unadjusted hazard ratio [HR] 1.24 [95% CI 1.01-1.53]; p=0.041). Although a higher number of deaths overall occurred in the 1 cm group compared with the 3 cm group (253 vs 241), the difference was not significant (unadjusted HR 1.14 [95% CI 0.96-1.36]; p=0.14). Surgical complications were reported in 35 (8%) patients in the 1 cm excision margin group and 65 (15%) patients in the 3 cm group.Interpretation Our findings suggest that a 1 cm excision margin is inadequate for cutaneous melanoma with Breslow thickness greater than 2 mm on the trunk and limbs. Current guidelines advise a 2 cm margin for melanomas greater than 2 mm in thickness but only a 1 cm margin for thinner melanomas. The adequacy of a 1 cm margin for thinner melanomas with poor prognostic features should be addressed in future randomised studies. Copyright (C) Hayes et al. Open Access article distributed under the terms of CC BY.