2-cm and 4-cm surgical excision margins did not differ for survival in cutaneous melanoma > 2 mm thick

摘要

Does surgery with 2-cm excision margins differ from surgery with 4-cm excision margins for survival in patients with cutaneous melanoma > 2 mm thick?Methods Design: Randomized, controlled, equivalency trial. ClinicalTrials. govNCT01183936.Allocation: Concealed. Blinding: Unblinded.Follow-up period: Median 6.7 years. Trial was stopped early because of changing clinical practice and decreasing enrollment.Setting: 53 hospitals in Sweden, Denmark, Estonia, and Norway.Patients: 936 patients < 75 years of age (median age 59 to 60 y,64% men) who had a primary, clinically localized cutaneous melanoma > 2 mm thick on the trunk, arms, or legs. Exclusion criteria were cutaneous melanoma on hands, feet, head and neck, or anogenital region; past cutaneous melanoma; or other malignant disease (except basal cell carcinoma or in situ cervical cancer).Intervention: Radical surgery with a 2-cm (n = 465) or 4-cm (n = 471) excision margin.Outcomes: Overall survival and recurrence-free survival. 1000 patients were needed to detect a reduction in 5-year survival from 60% to 50% (90% power, a = 0.05) at interim analysis. 2000 patients were planned to evaluate treatment equivalency.Patient follow-up: > 99% (intention-to-treat analysis).