Oral nicotinamide, a derivative of vitamin B3 (niacin), was effective and safe in reducing the rates of new nonmelanoma skin cancers, such as basal-cell carcinoma and squamous-cell carcinoma, and actinic keratoses, pre-cancerous patches of rough, scaly skin, in high-risk patients, a study published in The New England Journal of Medicine has shown.
For the double-blind, controlled, phase 3 ONTRAC study, researchers enrolled 386 patients who had had at least 2 nonmelanoma skin cancers in the last 5 years. Participants were randomly assigned 1:1 to receive nicotinamide 500 mg twice daily or placebo for 1 year, and were evaluated by dermatologists every 3 months for 18 months.
Results showed that at 12 months, rate of new nonmelanoma skin cancers was 23% (95% CI, 4 – 48) lower in the nicotinamide group than in the placebo group (P = .02).
Researchers also found a 20% (95% CI, -6 to 39) lower rate of new basal-cell carcinomas and a 30% (95% CI, 0 – 51) lower rate of squamous-cell carcinomas with nicotinamide compared with placebo (P = .12 and .05, respectively).
The rate of actinic keratoses was 13% lower at 12 months in the nicotinamide group than the placebo group (P = .001). Of note, the benefit from nicotinamide only lasted as long as nicotinamide was continued.
In terms of safety, researchers observed no significant differences in adverse events between the 2 treatment arms.
“This is the first clear evidence that we can reduce skin cancers using a simple vitamin, together with sensible sun protection,” said lead author Diona Damian, PhD, professor of dermatology at the University of Sydney and Royal Prince Alfred Hospital in Australia.
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“We hope that these findings can be immediately translated into clinical practice. However, people at high risk of skin cancer still need to practice sun safe behavior, use sunscreens and have regular check-ups with their doctor.” Dr. Damian stressed.
Preliminary findings (Abstract 9000) were presented at the 2015 ASCO Annual Meeting in Chicago, IL, in May.
- Chen AC, Martin AJ, Choy B, et al. A phase 3 randomized trial of nicotinamide for skin-cancer chemoprevention. N Engl J Med. 2015; 373(17):1618-1626.