title: Surgical margins in cutaneous melanoma (2 cm versus 5 cm for lesions measuring less than 2.1-mm thick).
abstract: BACKGROUND
  This study addressed the question of whether limited surgery for primary malignant melanoma with a 2-cm margin is as good as a 5-cm margin. An update of a 16-year follow-up is provided.
  
  
  METHODS
  Nine European Centers, over a period of 5 years, prospectively randomized 337 patients with melanoma measuring less than 2.1 mm in thickness to undergo a local excision with either a 2-cm or a 5-cm margin. Three hundred twenty-six patients were eligible for statistical analysis. Excluded from the trial were patients older than 70 years; those with melanomas from the toe, nail, or finger; and those with acral-lentiginous melanoma. A separate randomization was performed to independently test an adjuvant treatment with a nonspecific immunostimulant, isoprinosine, compared with observation. The median follow-up time was 192 months (16 years) for the estimation of survival and disease recurrences.
  
  
  RESULTS
  There were 22 tumor recurrences in the 2-cm arm and 33 in the 5-cm arm. The median time to disease recurrence was 43 months and 37.6 months, respectively. The 10-year disease-free survival rates were 85% for the group with a 2-cm margin and 83% for the group with a 5-cm margin. There was no difference in the 10-year overall survival rates (87% vs. 86%). Isoprinosine did not demonstrate any activity in this setting.
  
  
  CONCLUSIONS
  The authors concluded that for melanoma less than 2.1-mm thick, a margin of excision of 2 cm is sufficient. A larger margin of 5 cm does not appear to have any impact on either the rate or the time to disease recurrence or on survival.
authors.affiliation: Service d'Oncologie Médicale, Hôpital Pitié-Salpêtrière, Paris, France. david.khayat@psl.ap-hop-paris.fr
authors.forename: David
authors.initials: D
authors.lastname: Khayat
authors.forename: Olivier
authors.initials: O
authors.lastname: Rixe
authors.forename: Ginette
authors.initials: G
authors.lastname: Martin
authors.forename: Claude
authors.initials: C
authors.lastname: Soubrane
authors.forename: Martine
authors.initials: M
authors.lastname: Banzet
authors.forename: Jacques-André
authors.initials: JA
authors.lastname: Bazex
authors.forename: Philippe
authors.initials: P
authors.lastname: Lauret
authors.forename: Olivier
authors.initials: O
authors.lastname: Vérola
authors.forename: Gérard
authors.initials: G
authors.lastname: Auclerc
authors.forename: Peter
authors.initials: P
authors.lastname: Harper
authors.forename: Pierre
authors.initials: P
authors.lastname: Banzet
mesh_terms: D000328:Adult; D001706:Biopsy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D008297:Male; D008545:Melanoma / Q000473:pathology* / Q000601:surgery*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000473:pathology* / Q000601:surgery*; D015996:Survival Rate