Nutrients (Jun 2021)
Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial
- Harriet Johansson,
- Giuseppe Spadola,
- Giulio Tosti,
- Mario Mandalà,
- Alessandro M. Minisini,
- Paola Queirolo,
- Valentina Aristarco,
- Federica Baldini,
- Emilia Cocorocchio,
- Elena Albertazzi,
- Leonardo Zichichi,
- Saverio Cinieri,
- Costantino Jemos,
- Giovanni Mazzarol,
- Patrizia Gnagnarella,
- Debora Macis,
- Ines Tedeschi,
- Emanuela Omodeo Salè,
- Luigia Stefania Stucci,
- Bernardo Bonanni,
- Alessandro Testori,
- Elisabetta Pennacchioli,
- Pier Francesco Ferrucci,
- Sara Gandini,
- on behalf of the Italian Melanoma Intergroup (IMI)
Affiliations
- Harriet Johansson
- Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Giuseppe Spadola
- Divisione di Chirurgia del Melanoma, IRCCS Fondazione Istituto Nazionale per lo Studio e la Cura dei Tumori, 20133 Milan, Italy
- Giulio Tosti
- Division of Surgery for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Mario Mandalà
- Unit of Medical Oncology, Department of Oncology and Haematology, Papa Giovanni XXIII Cancer Center Hospital, 24127 Bergamo, Italy
- Alessandro M. Minisini
- Department of Oncology, Azienda Sanitaria Universitaria del Friuli Centrale, 33100 Udine, Italy
- Paola Queirolo
- Department of Medical Oncology, IRCCS Ospedale Policlinico San Martino—IST-Istituto Nazionale per la Ricerca sul Cancro, 16132 Genoa, Italy
- Valentina Aristarco
- Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Federica Baldini
- Division of Surgery for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Emilia Cocorocchio
- Division of Medical Oncology for Melanoma, Sarcoma and Rare Tumors, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Elena Albertazzi
- San Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy
- Leonardo Zichichi
- Dermatology Unit, Ospedale S.A. Abate, 91016 Erice, Italy
- Saverio Cinieri
- Medical Oncology & Breast Unit, Department of Oncology, “Antonio Perrino” Hospital, 72100 Brindisi, Italy
- Costantino Jemos
- Division of Pharmacy, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Giovanni Mazzarol
- Division of Pathology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Patrizia Gnagnarella
- Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy
- Debora Macis
- Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Ines Tedeschi
- Division of Surgery for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Emanuela Omodeo Salè
- Division of Pharmacy, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Luigia Stefania Stucci
- Section of Medical Oncology, Department of Biomedical Sciences and Clinical Oncology (DIMO), University of Bari ‘Aldo Moro’, 70124 Bari, Italy
- Bernardo Bonanni
- Division of Cancer Prevention and Genetics, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Alessandro Testori
- EORTC Melanoma Group, 1200 Brussel, Belgium
- Elisabetta Pennacchioli
- Division of Surgery for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- Pier Francesco Ferrucci
- Biotherapy of Tumors Unit, IEO, Department of Experimental Oncology, European Institute of Oncology, IRCCS, 20141 Milan, Italy
- Sara Gandini
- Department of Experimental Oncology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy
- on behalf of the Italian Melanoma Intergroup (IMI)
- DOI
- https://doi.org/10.3390/nu13061931
- Journal volume & issue
-
Vol. 13,
no. 6
p. 1931
Abstract
Patients with newly resected stage II melanoma (n = 104) were randomized to receive adjuvant vitamin D3 (100,000 IU every 50 days) or placebo for 3 years to investigate vitamin D3 protective effects on developing a recurrent disease. Median age at diagnosis was 50 years, and 43% of the patients were female. Median serum 25-hydroxy vitamin D (25OHD) level at baseline was 18 ng/mL, interquartile range (IQ) was 13–24 ng/mL, and 80% of the patients had insufficient vitamin D levels. We observed pronounced increases in 25OHD levels after 4 months in the active arm (median 32.9 ng/mL; IQ range 25.9–38.4) against placebo (median 19.05 ng/mL; IQ range 13.0–25.9), constantly rising during treatment. Remarkably, patients with low Breslow score (p = 0.02) compared to those with Breslow score p = 0.011). Despite the evidence of a role of 25OHD in melanoma prognosis, larger trials with vitamin D supplementation involving subjects with melanoma are needed.
Keywords