D. Nold1, J. M. Mammen1 1University Of Kansas,Surgery,Kansas City, KS, USA
Introduction:
The primary treatment of localized malignant melanoma is wide local excision in which a predetermined margin of skin and subcutaneous tissue is removed around the pigmented lesion. The margins for thin (1mm or less) and thick (greater than 2mm) melanoma are well known and validated. The standard of care margin for intermediate thickness (1.01mm to 2mm Breslow thickness) melanomas by NCCN and other treatment guidelines is 1cm or 2cm. While retrospective studies have attempted to settle the issue of margins for intermediate thickness melanomas, no randomized clinical trial is available for guidance. Currently, the MelmarT clinical trial is accruing patients in New Zealand and Australia and is scheduled to complete accrual in 2029 with a total of 400 subjects planned. The authors have started an clinical trial to determine the feasibility of randomizing eligible melanoma patients in the United States
Methods:
Institutional Review Board permission was obtained for a feasibility trial that randomizes 1:1 eligible intermediate thickness (1.01mm to 2mm Breslow thickness) melanoma patients to 1cm or 2cm margins. Total accrual goal for this 2 year study is 60 patients. Exclusion criteria include location of the melanoma (head and neck, hands, feet), residual pigmentation suggesting additional thickness, and a positive deep margin.
Results:
The "Pilot Study of 1cm versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma" was opened at the University of Kansas on January 30, 2017. All eligible patients who presented to the Melanoma Surgical Oncology clinic were evaluated for this trial. A total of 146 new localized melanoma patients were seen from January 30, 2017 to October 30, 2017. During that time period, 41 (28%) of the new patients had cT2N0M0 melanomas. Of that group, 12 (29.2%) of the patients had melanomas at sites excluded by the study. Ultimately, 9 patients enrolled in the study during this time period (one enrollee monthly on average). A variety of patient preferences and physician preferences (for example, avoiding a skin graft in locations like the distal anterior leg) led to additional eligible patients not enrolling.
Conclusion:
A clinical trial to randomize intermediate thickness melanoma patients to 1cm or 2cm margins appears to be feasible in the United States. Currently, a single institution feasibility trial is accruing one patient monthly, though two additional patients monthly appear to be eligible