Follow-up Schedule for Patients With Sentinel Node-negative Cutaneous Melanoma (The MELFO Study): An International Phase III Randomized Clinical Trial.

Autor:	Moncrieff MD; Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK., Bastiaannet E; Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland., Underwood B; Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK., Francken AB; Department of Surgical Oncology, Isala Clinics, Zwolle, The Netherlands., Garioch J; Department of Dermatology, Norfolk & Norwich University Hospital, Norwich, UK., Damude S; Department of Surgical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Heaton M; Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK., Deckers EA; Department of Surgical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Patel N; Department of Plastic & Reconstructive Surgery, Norfolk & Norwich University Hospital, Norwich, UK., Hoekstra-Weebers JE; University Medical Centre Groningen, Wenckebach Institute, University of Groningen, Groningen, The Netherlands., Hoekstra HJ; Department of Surgical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2022 Oct 01; Vol. 276 (4), pp. e208-e216. Date of Electronic Publication: 2022 Jul 22.
DOI:	10.1097/SLA.0000000000005621
Abstrakt:	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. Competing Interests: The authors report no conflicts of interest. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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