2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: A randomised, multicentre trial

Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
The Lancet (Impact Factor: 45.22). 11/2011; 378(9803):1635-42. DOI: 10.1016/S0140-6736(11)61546-8
Source: PubMed


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.
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, number NCT01183936.
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 60-70) [corrected] in the 2-cm group and 65% (40-70) in the 4-cm group (p=0·69).
Our findings suggest that a 2-cm resection margin is sufficient and safe for patients with cutaneous melanoma thicker than 2 mm.
Swedish Cancer Society and Stockholm Cancer Society.

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    • "j.jcms.2013.09.007 margin was associated with a greater risk of regional recurrence than the 3 cm excision margin, but with similar overall survival rate (Thomas et al., 2004). In another recent Swedish multicentre trial on malignant melanomas thicker than 2 mm of all sites, a 4 cm resection margin did not show superiority over 2 cm resection margin (Gillgren et al., 2011). An analysis of the Cochrane Data Base showed no advantage of wide (3e5 cm) excision margins over narrow (1e2 cm) excision margins (Sladden et al., 2009). "
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    ABSTRACT: Head and neck melanoma compromises a group of aggressive tumours with varying clinical courses. This analysis was performed to find anatomic and clinicopathological parameters predictive for lymph node metastasis and overall survival. Data and outcome of 246 patients with a malignant melanoma in the head and neck region were retrospectively analyzed for predictive parameters. Lentigo maligna melanoma (n = 115) was the most frequent histology, followed by superficial spreading (n = 63) and nodular melanoma (n = 52). More than half of the melanomas (n = 138) were in the face. Tumours of the face and anterior scalp metastasized to lymph nodes of the neck and parotid gland, whereas tumours of the posterior scalp and neck also metastasized to the nuchal region. Advanced Clark level, presence of tumour ulceration and younger age were the strongest predictors of lymph node metastasis in multivariate regression analysis (p < 0.05), but anatomic site, histological subtype and tumour thickness were also associated with lymph node metastasis. Lymph node metastases, distant metastases, ulceration, nodular subtype and non-facial site of origin were the strongest negative prognostic parameters for disease-specific overall survival (p < 0.05). In contrast, the width of resection margin (<1 cm vs. 1-2 cm vs. >2 cm) did not correlate with tumour recurrence and overall survival (p > 0.05). Histological subtype diagnosis, anatomic site of origin as well as the established factors tumour thickness, ulceration and depth of invasion are prognostic indicators of cervical lymph node metastasis and overall survival. A resection margin of at least 1 cm seems sufficient in head and neck melanoma. The status of sentinel lymph node biopsy and neck dissection has to be proven within the next years.
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