当前位置: X-MOL 学术Lancet › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: long-term follow-up of a multicentre, randomised trial.
The Lancet ( IF 168.9 ) Pub Date : 2019-07-04 , DOI: 10.1016/s0140-6736(19)31132-8
Deborah Utjés 1 , Jonas Malmstedt 2 , Jüri Teras 3 , Krzysztof Drzewiecki 4 , Hans Petter Gullestad 5 , Christian Ingvar 6 , Hanna Eriksson 7 , Peter Gillgren 2
Affiliation  

BACKGROUND The optimal surgical excision margins are uncertain for patients with thick (>2 mm) localised cutaneous melanomas. In our previous report of this multicentre, randomised controlled trial, with a median follow-up of 6·7 years, we showed that a narrow excision margin (2 cm vs 4 cm) did not affect melanoma-specific nor overall survival. Here, we present extended follow-up of this cohort. METHODS In this open-label, multicentre randomised controlled trial, we recruited patients from 53 hospitals in Sweden, Denmark, Estonia, and Norway. We enrolled clinically staged patients aged 75 years or younger diagnosed with localised cutaneous melanoma thicker than 2 mm, and with primary site on the trunk or upper or lower extremities. Patients were randomly allocated (1:1) to treatment either with a 2-cm or a 4-cm excision margin. A physician enrolled the patients after histological confirmation of a cutaneous melanoma thicker than 2 mm. Some patients were enrolled by a physician acting as responsible for clinical care and as a trial investigator (follow-up, data collection, and manuscript writing). In other cases physicians not involved in running the trial enrolled patients. Randomisation was done by telephone call to a randomisation office, by sealed envelope, or by computer generated lists using permuted blocks. Patients were stratified according to geographical region. No part of the trial was masked. The primary outcome in this extended follow-up study was overall survival and the co-primary outcome was melanoma-specific survival. All analyses were done on an intention-to-treat basis. The study is registered with ClinicalTrials.gov, number NCT03638492. FINDINGS Between Jan 22, 1992, and May 19, 2004, 936 clinically staged patients were recruited and randomly assigned to a 4-cm excision margin (n=465) or a 2-cm excision margin (n=471). At a median overall follow-up of 19·6 years (235 months, IQR 200-260), 621 deaths were reported-304 (49%) in the 2-cm group and 317 (51%) in the 4-cm group (unadjusted HR 0·98, 95% CI 0·83-1·14; p=0·75). 397 deaths were attributed to cutaneous melanoma-192 (48%) in the 2-cm excision margin group and 205 (52%) in the 4-cm excision margin group (unadjusted HR 0·95, 95% CI 0·78-1·16, p=0·61). INTERPRETATION A 2-cm excision margin was safe for patients with thick (>2 mm) localised cutaneous melanoma at a follow-up of median 19·6 years. These findings support the use of 2-cm excision margins in current clinical practice. FUNDING The Swedish Cancer Society, Stockholm Cancer Society, the Swedish Society for Medical Research, Radiumhemmet Research funds, Stockholm County Council, Wallström funds.

中文翻译:

厚度大于2 mm的原发性皮肤黑色素瘤的2 cm与4 cm手术切除切缘:一项多中心随机试验的长期随访。

背景技术对于厚的(> 2 mm)局限性皮肤黑色素瘤患者,最佳手术切除余量尚不确定。在我们先前关于这项多中心,随机对照试验的报告中,中位随访时间为6·7年,我们显示狭窄的切缘(2厘米对4厘米)不会影响黑色素瘤特异性或总体生存率。在这里,我们介绍了该队列的扩展随访。方法在这项开放性,多中心,随机对照试验中,我们从瑞典,丹麦,爱沙尼亚和挪威的53家医院招募了患者。我们招募了年龄在75岁以下的临床分期患者,这些患者被诊断出局灶性皮肤黑色素瘤厚度超过2 mm,主要部位在躯干或上肢或下肢。患者被随机分配(1:1)进行2 cm或4 cm切除切缘的治疗。在组织学上证实厚度超过2毫米的皮肤黑色素瘤后,一名医生招募了患者。一些患者由负责临床护理和试验研究人员的医师(随访,数据收集和手稿撰写)招募。在其他情况下,不参与运行试验的医生招募了患者。可以通过打给随机办公室的电话,密封的信封或使用排列好的模块的计算机生成的列表来进行随机化。根据地理区域对患者进行分层。审判的任何部分都没有被掩盖。在这项扩展的随访研究中,主要结果是总体生存,共同主要结果是黑素瘤特异性生存。所有分析均在意向性治疗的基础上进行。该研究已在ClinicalTrials.gov上注册,编号为NCT03638492。结果在1992年1月22日至2004年5月19日之间,共招募了936名经过临床分期的患者,并随机分配了4 cm切除切缘(n = 465)或2 cm切除切缘(n = 471)。在平均随访19·6年(235个月,IQR 200-260)中,报告2厘米组621例死亡,其中304例(49%),4厘米组317例(51%)。 (未经调整的HR 0·98,95%CI 0·83-1·14; p = 0·75)。2 cm切缘组中397例死于皮肤黑素瘤-192(48%),4 cm切缘组中205例(52%)(未调整HR 0·95,95%CI 0·78-1 ·16,p = 0·61)。解释在中位19·6年的随访中,对于2mm厚的局限性皮肤黑色素瘤患者,切除2 cm的切缘是安全的。这些发现支持在当前临床实践中使用2 cm切除切缘。资助瑞典癌症协会,
更新日期:2019-08-09
down
wechat
bug