| Autor: |
Smedt, Julie De, Kelst, Sofie Van, Janssen, Laudine, Marasigan, Vivien, Boecxstaens, Veerle, Bogaerts, Kris, Belmans, Ann, Vanderschueren, Dirk, Vandenberghe, Katleen, Bechter, Oliver, Aura, Claudia, Lambrechts, Diether, Strobbe, Tinne, Emri, Gabriella, Nikkels, Arjen, Garmyn, Marjan |
| Předmět: |
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| Zdroj: |
British Journal of Dermatology; Dec2024, Vol. 191 Issue 6, p886-896, 11p |
| 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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