High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial).

Autor:	De Smedt J; Laboratory of Dermatology, Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium., Van Kelst S; Laboratory of Dermatology, Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium., Janssen L; Laboratory of Dermatology, Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium., Marasigan V; Department of Surgery, South Infirmary Victoria University Hospital, Cork, Ireland., Boecxstaens V; Oncological Surgery, Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium., Bogaerts K; Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven, Belgium., Belmans A; Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven, Belgium., Vanderschueren D; Clinical and Experimental Endocrinology, Department of Chronical Illness and Metabolism, KU Leuven, UZ Leuven, Leuven, Belgium., Vandenberghe K; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium., Bechter O; Laboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium., Aura C; Conway Institute of Biomolecular and Biomedical Research, Pathology, University College Dublin, Ireland., Lambrechts D; Laboratory for Translational Genetics, Department of Human Genetics, VIB-KU Leuven, Leuven, Belgium., Strobbe T; Department of Dermatology, Imeldaziekenhuis, Bonheiden, Belgium., Emri G; Department of Dermatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary., Nikkels A; CHU Sart Tilman, University of Liège, Department of Dermatology, Liège, Belgium., Garmyn M; Laboratory of Dermatology, Department of Oncology, KU Leuven, UZ Leuven, Leuven, Belgium.
Jazyk:	angličtina
Zdroj:	The British journal of dermatology [Br J Dermatol] 2024 Nov 18; Vol. 191 (6), pp. 886-896.
DOI:	10.1093/bjd/ljae257
Abstrakt:	Background: Observational studies in cutaneous melanoma (CM) have indicated an inverse relationship between levels of 25-hydroxyvitamin D and Breslow thickness, in addition to a protective effect of high 25-hydroxyvitamin D levels on clinical outcome. Objectives: To evaluate whether high-dose vitamin D supplementation in curatively resected CM reduces melanoma relapse. Methods: In a prospective randomized double-blind placebo-controlled trial, 436 patients with resected CM stage IA to III (8th American Joint Committee on Cancer staging) were randomized. Among them, 218 received a placebo while 218 received monthly 100 000 IU cholecalciferol for a minimum of 6 months and a maximum of 42 months (treatment arm). Following randomization, patients were followed for a median of 52 months, with a maximum follow-up of 116 months. The primary endpoint was relapse-free survival. Secondary endpoints were melanoma-related mortality, overall survival, and the evolution of 25-hydroxyvitamin D serum levels over time. Results: In our population (mean age 55 years, 54% female sex) vitamin D supplementation increased 25-hydroxyvitamin D serum levels after 6 months of supplementation in the treatment arm by a median 17 ng mL-1 [95% confidence interval (CI) 9-26] compared with 0 ng mL-1 (95% CI 6-8) in the placebo arm (P < 0.001, Wilcoxon test) and remained at a steady state during the whole treatment period. The estimated event rate for relapse-free survival at 72 months after inclusion was 26.51% in the vitamin D supplemented arm (95% CI 19.37-35.64) vs. 20.70% (95% CI 14.26-29.52) in the placebo arm (hazard ratio 1.27, 95% CI 0.79-2.03; P = 0.32). After adjusting for confounding factors (including baseline stage, body mass index, age, sex and baseline season), the hazard ratio was 1.20 (95% CI 0.74-1.94, P = 0.46). The number of deaths from progression of CM and nonmelanoma-related deaths was similar in both the vitamin D supplemented and placebo groups (deaths from progression of CM, n = 10 and n = 11, respectively; nonmelanoma-related deaths, n = 3 and n = 2, respectively). No major adverse events were observed during the study. Conclusions: In patients with CM, monthly high-dose vitamin D supplementation was safe, resulted in a sustained increase in 25-hydroxyvitamin D levels during the treatment period, but did not improve relapse-free survival, melanoma-related death or overall survival. Competing Interests: Conflicts of interest The authors declare they have no conflicts of interest. (© The Author(s) 2024. Published by Oxford University Press on behalf of British Association of Dermatologists. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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