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

Gillgren, Peter; Drzewiecki, Krzysztof T.; Niin, Marianne; Gullestad, Hans P.; Hellborg, Henrik; Mansson-Brahme, Eva; Ingvar, Christian LU and Ringborg, Ulrik (2011) In The Lancet 378(9803). p.1635-1642
Abstract
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... (More)
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% (60-70) 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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet
volume
378
issue
9803
pages
1635 - 1642
publisher
Elsevier Limited
external identifiers
  • wos:000296768300028
  • scopus:80555148140
ISSN
1474-547X
DOI
10.1016/S0140-6736(11)61546-8
language
English
LU publication?
yes
id
a786e355-0769-44ab-adbb-b4385294fa0d (old id 2254369)
date added to LUP
2012-01-02 08:04:04
date last changed
2017-10-22 03:16:34
@article{a786e355-0769-44ab-adbb-b4385294fa0d,
  abstract     = {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% (60-70) 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.},
  author       = {Gillgren, Peter and Drzewiecki, Krzysztof T. and Niin, Marianne and Gullestad, Hans P. and Hellborg, Henrik and Mansson-Brahme, Eva and Ingvar, Christian and Ringborg, Ulrik},
  issn         = {1474-547X},
  language     = {eng},
  number       = {9803},
  pages        = {1635--1642},
  publisher    = {Elsevier Limited},
  series       = {The Lancet},
  title        = {2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial},
  url          = {http://dx.doi.org/10.1016/S0140-6736(11)61546-8},
  volume       = {378},
  year         = {2011},
}