Follow-up Schedule for Patients With Sentinel Node-negative Cutaneous Melanoma (The MELFO Study) An International Phase III Randomized 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, Harald J. Hoekstra

*Corresponding author for this work

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Objectives and Design: The MELFO (MELanoma FOllow-up) study is an international phase III randomized controlled trial comparing an experimental low-intensity schedule against current national guidelines. Background: Evidence-based guidelines for the follow-up of sentinel node-negative melanoma patients are lacking. Methods: Overall, 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. Results: At 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). Conclusions: A 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.

Original languageEnglish
Pages (from-to)E208-E216
Number of pages9
JournalAnnals of Surgery
Issue number4
Publication statusPublished - Oct-2022


  • cancer follow-up
  • detection rates
  • follow-up
  • melanoma
  • patient-reported outcome measures
  • self-examination
  • sentinel node biopsy
  • survival

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