• Annals of surgery · Oct 2022

    Randomized Controlled Trial

    Follow-up Schedule for Patients with Sentinel Node Negative Cutaneous Melanoma: an International Phase III Randomised Clinical Trial.

    • Marc D Moncrieff, Esther Bastiaannet, Beverly Underwood, Anne Brecht Francken, Jennifer Garioch, Samantha Damude, Martin Heaton, Eric A Deckers, Nakul Patel, Josette E Hoekstra-Weebers, and Harald J Hoekstra.
    • Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK.
    • Ann. Surg. 2022 Oct 1; 276 (4): e208-e216.

    Objectives And DesignThe MELFO (MELanoma FOllow-up) study is an international phase III randomized controlled trial comparing an experimental low-intensity schedule against current national guidelines.BackgroundEvidence-based guidelines for the follow-up of sentinel node-negative melanoma patients are lacking.MethodsOverall, 388 adult patients diagnosed with sentinel node-negative primary melanoma patients were randomized in cancer centers in the Netherlands and United Kingdom between 2006 and 2016. The conventional schedule group (control: n=196) was reviewed as per current national guidelines. The experimental schedule group (n=192) was reviewed in a reduced-frequency schedule. Quality of life was the primary outcome measurement. Detection rates and survival outcomes were recorded. Patient satisfaction rates and compliance with allocated schedules were compared.ResultsAt 5 years, both arms expressed high satisfaction with their regimens (>97%). This study found no significant group effect on any patient-reported outcome measure scores between the follow-up protocols. In total, 75/388 (19.4%) patients recurred, with no difference in incidence found between the 2 arms (hazard ratio=0.87, 95% confidence interval: 0.54-1.39, P =0.57). Self-examination was the method of detection for 25 experimental patients and 32 control patients (75.8% vs. 76.2%; P =0.41). This study found no difference in any survival outcomes between the 2 study arms (disease-free survival: hazard ratio=1.00, 95% confidence interval: 0.49-2.07, P =0.99).ConclusionsA reduced-intensity, American Joint Committee on Cancer (AJCC) stage-adjusted follow-up schedule for sentinel node-negative melanoma patients is a safe strategy, and patient self-examination is effective for recurrence detection with no evidence of diagnostic delay. Patients' acceptance is very high.Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

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