Surgical margins in cutaneous melanoma (2 cm versus 5 cm for lesions measuring less than 2.1-mm thick).
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.
Khayat
David
D
Service d'Oncologie Médicale, Hôpital Pitié-Salpêtrière, Paris, France. david.khayat@psl.ap-hop-paris.fr
Rixe
Olivier
O
Martin
Ginette
G
Soubrane
Claude
C
Banzet
Martine
M
Bazex
Jacques-André
JA
Lauret
Philippe
P
Vérola
Olivier
O
Auclerc
Gérard
G
Harper
Peter
P
Banzet
Pierre
P
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