Carlos Garcia, MD
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?
Randomized, controlled, equivalency trial. ClinicalTrials.gov NCT01183936.
Median 6.7 years. Trial was stopped early because of changing clinical practice and decreasing enrollment.
53 hospitals in Sweden, Denmark, Estonia, and Norway.
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).
Radical surgery with a 2-cm (n = 465) or 4-cm (n = 471) excision margin.
Overall survival and recurrence-free survival. 1000 patients were needed to detect a reduction in 5-year survival from 60% to 50% (90% power, α = 0.05) at interim analysis. 2000 patients were planned to evaluate treatment equivalency.
> 99% (intention-to-treat analysis).
At 5 years, overall survival was 65% in each group (P = 0.69), and recurrence-free survival was 56% in each group (P = 0.82). Results for mortality and recurrence at a median 6.7 years of follow-up are reported in the Table.
Radical surgery with 2-cm excision margins did not differ from that with 4-cm margins for survival in patients with cutaneous melanoma > 2 mm thick.
Radical surgery with 2-cm vs 4-cm excision margins in cutaneous melanoma > 2 mm thick†
†Abbreviations defined in Glossary. RRI, RRR, and CI calculated from hazard ratios and event rates in the 4-cm group reported in article.
Garcia C. 2-cm and 4-cm surgical excision margins did not differ for survival in cutaneous melanoma > 2 mm thick. Ann Intern Med. ;156:JC5–7. doi: 10.7326/0003-4819-156-10-201205150-02007
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Published: Ann Intern Med. 2012;156(10):JC5-7.
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