Excision margins in high-risk malignant melanoma

N Engl J Med. 2004 Feb 19;350(8):757-66. doi: 10.1056/NEJMoa030681.


Background: Controversy exists concerning the necessary margin of excision for cutaneous melanoma 2 mm or greater in thickness.

Methods: We conducted a randomized clinical trial comparing 1-cm and 3-cm margins.

Results: Of the 900 patients who were enrolled, 453 were randomly assigned to undergo surgery with a 1-cm margin of excision and 447 with a 3-cm margin of excision; the median follow-up was 60 months. A 1-cm margin of excision was associated with a significantly increased risk of locoregional recurrence. There were 168 locoregional recurrences (as first events) in the group with 1-cm margins of excision, as compared with 142 in the group with 3-cm margins (hazard ratio, 1.26; 95 percent confidence interval, 1.00 to 1.59; P=0.05). There were 128 deaths attributable to melanoma in the group with 1-cm margins, as compared with 105 in the group with 3-cm margins (hazard ratio, 1.24; 95 percent confidence interval, 0.96 to 1.61; P=0.1); overall survival was similar in the two groups (hazard ratio for death, 1.07; 95 percent confidence interval, 0.85 to 1.36; P=0.6).

Conclusions: A 1-cm margin of excision for melanoma with a poor prognosis (as defined by a tumor thickness of at least 2 mm) is associated with a significantly greater risk of regional recurrence than is a 3-cm margin, but with a similar overall survival rate.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Life Tables
  • Male
  • Melanoma / mortality
  • Melanoma / pathology
  • Melanoma / surgery*
  • Middle Aged
  • Neoplasm Recurrence, Local / epidemiology
  • Prognosis
  • Proportional Hazards Models
  • Risk
  • Skin Neoplasms / mortality
  • Skin Neoplasms / pathology
  • Skin Neoplasms / surgery*
  • Surgical Procedures, Operative / methods
  • Survival Rate