• Nicholas C Allen, Andrew J Martin, Victoria A Snaidr, Renee Eggins, Alvin H Chong, Pablo Fernandéz-Peñas, Douglas Gin, Shireen Sidhu, Vanessa L Paddon, Leith A Banney, Adrian Lim, Edward Upjohn, Helmut Schaider, Aparna D Ganhewa, Jennifer Nguyen, Catriona A McKenzie, Saurabh Prakash, Catriona McLean, Alistair Lochhead, Jan Ibbetson, Andrew Dettrick, Anthony Landgren, Katherine J Allnutt, Clare Allison, Rachael B Davenport, Blake P Mumford, Brittany Wong, Brendan Stagg, Alexander Tedman, Hannah Gribbin, Harrison A Edwards, Nicholas De Rosa, Thomas Stewart, Brent J Doolan, Yonatan Kok, Kate Simpson, Zhi M Low, Tom Kovitwanichkanont, Richard A Scolyer, Haryana M Dhillon, Janette L Vardy, Steven J Chadban, David G Bowen, Andrew C Chen, and Diona L Damian.
• From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and the A.W. Morrow Gastroenterology and Liver Centre (D.G.B.), Royal Prince Alfred Hospital, Camperdown, NSW, the Skin Health Institute, Carlton, VIC (A.H.C., K.J.A., R.B.D., B.P.M., T.K.), the Department of Dermatology, University of Sydney at Westmead Hospital, Westmead, NSW (P.F.-P.), the Department of Dermatology, the Alfred Hospital (D.G., A.D.G., J.N.), the Department of Anatomical Pathology, Alfred Health (C.M.), and the Department of Anatomical Pathology, Royal Melbourne Hospital (A. Landgren), Melbourne, VIC, the Department of Dermatology, Royal Adelaide Hospital (S.S., C.A., B.W., B.S.), and South Australia Pathology (J.I.), Adelaide, SA, the Department of Dermatology, University of New South Wales at St. Vincent's Hospital (V.L.P., N.D.R., T.S.), NSW Health Pathology (C.A.M., R.A.S.), the Department of Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital (C.A.M., R.A.S.), Faculty of Medicine and Health (R.A.S., J.L.V., D.G.B.), Melanoma Institute Australia (R.A.S., D.L.D.), Charles Perkins Centre (R.A.S., S.J.C.), and the Centre for Medical Psychology and Evidence-Based Decision-Making (H.M.D., J.L.V.), University of Sydney, and the Liver Immunology Program, the Centenary Institute, University of Sydney and Royal Prince Alfred Hospital (D.G.B.), Sydney, the Departments of Dermatology (L.A.B., H.S., A.D., A.T., H.G., H.A.E.) and Pathology (A.D.), Sunshine Coast University Hospital, Griffith University Medical School (L.A.B.), and the School of Health and Behavioural Sciences, University of the Sunshine Coast (A.D.), Birtinya, QLD, the Department of Dermatology, University of Sydney at Royal North Shore Hospital, St. Leonards, NSW (A. Lim), the Department of Dermatology, Royal Melbourne Hospital, Parkville, VIC (E.U., B.J.D., Y.K., K.S., Z.M.L.), the Dermatology Research Centre, Diamantina Institute, the University of Queensland (H.S., H.A.E.), and the Department of Dermatology, Princess Alexandra Hospital (H.A.E.), Woolloongabba, QLD, Melbourne Pathology, Sonic Healthcare, Collingwood, VIC (S.P.), Southern.IML Pathology, Sonic Healthcare, Coniston, NSW (A. Lochhead), Wollongong Hospital, Wollongong, NSW (A. Lochhead), the School of Medicine, University of Queensland, Herston (A.T.), and the Department of Medicine, Concord Clinical School, University of Sydney, and Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (J.L.V.) - all in Australia.
• N. Engl. J. Med. 2023 Mar 2; 388 (9): 804812804-812.

BackgroundImmunosuppressed organ-transplant recipients have an increased incidence of, and mortality from, skin cancer. Nicotinamide (vitamin B3) enhances the repair of ultraviolet (UV) radiation-induced DNA damage, reduces the cutaneous immunosuppressive effects of UV radiation, and reduces the incidence of keratinocyte cancers (including squamous-cell and basal-cell carcinomas) and actinic keratoses among high-risk immunocompetent patients. Whether oral nicotinamide is useful for skin-cancer chemoprevention in organ-transplant recipients is unclear.MethodsIn this phase 3 trial, we randomly assigned, in a 1:1 ratio, organ-transplant recipients who had had at least two keratinocyte cancers in the past 5 years to receive 500 mg of nicotinamide or placebo twice daily for 12 months. Participants were examined for skin lesions by dermatologists at 3-month intervals for 12 months. The primary end point was the number of new keratinocyte cancers during the 12-month intervention period. Secondary end points included the numbers of squamous-cell and basal-cell carcinomas during the 12-month intervention period, the number of actinic keratoses until 6 months after randomization, safety, and quality of life.ResultsA total of 158 participants were enrolled, with 79 assigned to the nicotinamide group and 79 to the placebo group. The trial was stopped early owing to poor recruitment. At 12 months, there were 207 new keratinocyte cancers in the nicotinamide group and 210 in the placebo group (rate ratio, 1.0; 95% confidence interval, 0.8 to 1.3; P = 0.96). No significant between-group differences in squamous-cell and basal-cell carcinoma counts, actinic keratosis counts, or quality-of-life scores were observed. Adverse events and changes in blood or urine laboratory variables were similar in the two groups.ConclusionsIn this 12-month, placebo-controlled trial, oral nicotinamide therapy did not lead to lower numbers of keratinocyte cancers or actinic keratoses in immunosuppressed solid-organ transplant recipients. (Funded by the National Health and Medical Research Council; ONTRANS Australian New Zealand Clinical Trials Registry number, ACTRN12617000599370.).Copyright © 2023 Massachusetts Medical Society.

28 keywords...

hide…