Trials Evaluating Surgical Margins in Melanoma

  • Historically, even thin melanomas were excised with very wide margins (3 to 5 cm):
    • Studies have demonstrated, however, that narrower margins are often associated with the same recurrence rates as wider margins
  • The first randomized study involving surgical margins for melanomas less than 2 mm thick:
    • Was reported by the WHO Melanoma Group Trial Number 10:
  • In an update of the study including 612 patients randomly assigned to a 1-cm or 3-cm margin of excision:
    • There were no local recurrences:
      • Among patients with primary melanomas thinner than 1 mm
    • There were four local recurrences among the 100 patients with melanomas 1 to 2 mm thick
      • All four occurred in patients with 1-cm margins
    • There was no significant difference in survival:
      • Between the 1- and 3-cm surgical margin groups
    • These results demonstrate that:
      • A 1-cm excision margin is safe for thin melanomas:
        • Less than 1 mm thick
  • A multi-institutional prospective randomized trial from France (French Cooperative Group Trial):
    • Compared 2 cm and 5 cm excisional margins in 362 patients:
      • With melanomas less than 2 mm thick
    • There were no differences in local recurrence rate or survival between the two groups
  • A randomized trial from Sweden (Swedish Melanoma Trial Group):
    • Compared 989 melanomas patients with lesions less than 2 mm thick excised with 2- and 5-cm margins
      • The results were similar
  • In regard to thicker lesions:
    • A randomized clinical trial from the United Kingdom:
      • The United Kingdom Melanoma Study Group (UKMSG) Trial:
        • Compared 1- and 3-cm excisional margins in 900 patients with melanomas at least 2 mm thick
          • With a median follow-up time of 60 months:
            • A 1-cm margin was associated with a significantly increased risk of locoregional recurrence:
            • 37% vs. 32% for 3-cm margins
          • However, overall survival (OS) was similar in the two groups
  • For intermediate thickness lesions:
    • A randomized prospective study conducted by the Intergroup Melanoma Committee:
      • Compared 2- and 4-cm radial margins of excision for 1- to 4-mm thickness melanomas
      • There was no difference in local recurrence rate between the two groups
      • 46% of patients in the 4-cm group required skin grafts:
        • Whereas only 11% of patients in the 2-cm group did (P < 0.001)
        • Of note, however, a trend for improved 10-year disease-specific survival was seen in 4-cm margins (77%) versus 2-cm margins (70%)
  • A clinical trial directly comparing 1- and 2-cm margins for 1- to 2-mm melanomas:
    • Has not been performed
    • Based upon data from the WHO Melanoma Group Number 10 Trial and the Intergroup Melanoma Trial:
      • 2-cm margins are recommended when the anatomic location is favorable and primary closure can be achieved
      • Since there is no demonstrable survival advantage for a 2-cm margin over a 1-cm margin in 1- to 2-mm melanomas:
        • A 1-cm margin can be justified in cases in which a 2-cm margin is not easily achievable
Randomized Trials Evaluating Margins in Melanoma
Summary of Recommendations for Primary Melanoma Excision Margins

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