1 Versus 2-cm Excision Margins for pT2-pT4 Primary Cutaneous Melanoma (MelMarT): A Feasibility Study

Abstract

BackgroundThere is a lack of consensus regarding optimal surgical excision margins for primary cutaneous melanoma > 1 mm in Breslow thickness (BT). A narrower surgical margin is expected to be associated with lower morbidity, improved quality of life (QoL), and reduced cost. We report the results of a pilot international study (MelMarT) comparing a 1 versus 2-cm surgical margin for patients with primary melanoma > 1 mm in BT.MethodsThis phase III, multicentre trial [NCT02385214] administered by the Australia & New Zealand Medical Trials Group (ANZMTG 03.12) randomised patients with a primary cutaneous melanoma > 1 mm in BT to a 1 versus 2-cm wide excision margin to be performed with sentinel lymph node biopsy. Surgical closure technique was at the discretion of the treating surgeon. Patients’ QoL was measured (FACT-M questionnaire) at baseline, 3, 6, and 12 months after randomisation.ResultsBetween January 2015 and June 2016, 400 patients were randomised from 17 centres in 5 countries. A total of 377 patients were available for analysis. Primary melanomas were located on the trunk (56.9%), extremities (35.6%), and head and neck (7.4%). More patients in the 2-cm margin group required reconstruction (34.9 vs. 13.6%; p < 0.0001). There was an increased wound necrosis rate in the 2-cm arm (0.5 vs. 3.6%; p = 0.036). After 12 months’ follow-up, no differences were noted in QoL between groups.DiscussionThis pilot study demonstrates the feasibility of a large international RCT to provide a definitive answer to the optimal excision margin for patients with intermediate- to high-risk primary cutaneous melanoma.

Health-related quality of life using the FACT-M questionnaire in patients with malignant melanoma: A systematic review

“…The median number of participants of each in the 14 patient cohorts was 319 (range 8e1245). The design differed between the reported patient cohorts, three randomized controlled trials [5,39,42], one phase I clinical trial [40], four prospective cohorts [6,10,34,36,38,40], five cross-sectional cohorts [37,41,43e45] and one retrospective cohort [46]. Seven of the studies reported a specific intervention, three systemic [5,39,43], three loco-regional Fig.…”

“…Chart of information through different phases of the systematic review in accordance with PRISMA [27]. [36,40,46] and one surgical [42]. There were nine studies from single centres ([6,34e37,43e46]) and seven multicentre studies [5,10,38e42].…”

Updates in the evidence‐based management of cutaneous melanoma

“…Extent of resection margin in patients with melanoma is the subject of a number of trials, with comparisons mostly ranging from 1 vs 3 cm or 2 vs 4 cm 17‐19 . In general, regardless of anatomic site, wider margins may translate to decreased risk of local recurrence but increase the chances of requiring complex closure and/or result in wound complications 20,21 . Some of these trials do not include patients with primary tumors in the head and neck though the same logic applies with the exception that wider margins may simply not be possible without removing a critical structure.…”

Experiences when irradiating grafts and flaps for skin cancer

“…16,17 The currently accruing MelMarT trial is assessing one versus two cm margins. 18 The margin is also influenced by the position of the lesion on the body e.g., nose versus back. Deep margin is taken to the deep fascia for melanoma.…”