Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients.
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Allen Nicholas C, Martin Andrew J, Snaidr Victoria A, Eggins Renee, Chong Alvin H, Fernandéz-Peñas Pablo, Gin Douglas, Sidhu Shireen, Paddon Vanessa L, Banney Leith A, Lim Adrian, Upjohn Edward, Schaider Helmut, Ganhewa Aparna D, Nguyen Jennifer, McKenzie Catriona A, Prakash Saurabh, McLean Catriona, Lochhead Alistair, Ibbetson Jan, Dettrick Andrew, Landgren Anthony, Allnutt Katherine J, Allison Clare, Davenport Rachael B, Mumford Blake P, Wong Brittany, Stagg Brendan, Tedman Alexander, Gribbin Hannah, Edwards Harrison A, De Rosa Nicholas, Stewart Thomas, Doolan Brent J, Kok Yonatan, Simpson Kate, Low Zhi M, Kovitwanichkanont Tom, Scolyer Richard A, Dhillon Haryana M, Vardy Janette L, Chadban Steven J, Bowen David G, Chen Andrew C, Damian Diona L
Аннотация
METHODS: In 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.
RESULTS: A 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.
CONCLUSIONS: In 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.).