Sufficiency and safety of 2-cm excision margin for stage IIA through stage IIC cutaneous melanoma.

Question: In patients with clinical stage IIA through IIC cutaneous melanoma thicker than 2 mm, is survival different for a 2-cm local excision margin compared with a 4-cm excision margin? Design: Randomized controlled trial. The trial was not masked at any stage. Setting: Multicenter trial in 53 hospitals in 9 European centers in Sweden, Denmark, Estonia, and Norway. Patients: Patients 75 years or younger with primary cutaneous melanoma thicker than 2 mm and with clinically localized disease (clinical stage IIA-C), on the trunk or upper or lower extremities. Intervention: Wide 2-cm local excision margin compared with a 4-cm excision margin. Main Outcome Measures: The primary outcome was overall survival. Secondary outcomes were recurrence-free survival and the number of local recurrences. Adverse events were not systematically recorded. Results: A total of 936 patients were enrolled from January 22, 1992, to May 19, 2004; 465 were randomly allocated to treatment with a 2-cm resection margin, and 471 received treatment with a 4-cm margin. After a median follow-up of 6.7 years, 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=.64). Five-year overall survival was 65% (95% CI, 60%-69%) in the 2-cm group and 65% (95% CI, 60%-70%) in the 4-cm group (P=.69). Recurrencefree survival did not differ between the 2 groups (P=.82). The proportion of relapse-free patients at 5 years was 56% (95% CI, 51%-61%) in both treatment groups. Conclusions: Findings suggest that a 2-cm resection margin is sufficient and safe for patients with cutaneous melanoma thicker than 2 mm.