Author:
Moncrieff Marc D.,Gyorki David,Saw Robyn,Spillane Andrew J.,Peach Howard,Oudit Deemesh,Geh Jenny,Dziewulski Peter,Wilson Ewan,Matteucci Paolo,Pritchard-Jones Rowan,Olofsson Bagge Roger,Wright Frances C.,Crampton Nic,Cassell Oliver,Jallali Navid,Berger Adam,Kelly John,Hamilton Stephen,Durrani Amer,Lo Serigne,Paton Elizabeth,Henderson Michael A.
Abstract
Abstract
Background
There 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.
Methods
This 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.
Results
Between 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.
Discussion
This 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.
Publisher
Springer Science and Business Media LLC
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