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Nicotinamide reduces rate of new nonmelanoma skin cancers in high-risk patients
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Nicotinamide, a form of vitamin B3, conferred a 23% reduction in the rate of new, nonmelanoma skin cancers in high-risk patients who previously had skin cancer, according to results from the Australian ONTRAC clinical trial.
Nicotinamide — a water-soluble vitamin in the vitamin B group — is affordable and available as an over-the-counter drug in most countries, according to study background.
“Nicotinamide significantly reduced nonmelanoma skin cancers and keratosis in just 12 months in a group of pretty high-risk patients,” study researcher Diona Damian, MBBS, PhD, a professor of dermatology at the Dermatology University of Sydney, said during a press conference. “It’s safe, it’s almost obscenely inexpensive and it’s already widely, commercially available. This one is ready to go straight into the clinic.”
The analysis included 386 patients (mean age, 66 years) who had at least two nonmelanoma skin cancers in the previous 5 years and were treated at one of two treatment facilities in Sydney between 2012 and 2014. The patients had a mean of 8 nonmelanoma skin cancers in the past 5 years, and 63% of the patients were male.
Researchers randomly assigned patients 1:1 to a 500 mg nicotinamide twice daily or placebo for 12 months.
The primary endpoint was the number of new nonmelanoma skin cancers within 12 months. Secondary endpoints included number of squamous cell carcinomas, basal cell carcinomas and actinic keratoses.
The average new nonmelanoma skin cancer rate was 1.77 in the nicotinamide arm and 2.42 in the placebo arm. The estimated relative rate of reduction (RRR) with nicotinamide was 0.23 (95% CI, 0.04-0.38) when adjusted for treatment center and the patient’s history of nonmelanoma skin cancer and 0.27 (95% CI, 0.05-0.44) when unadjusted.
Nicotinamide also was associated with a reduced incidence of basal cell carcinomas (RRR = 0.2; 95% CI, –0.06 to 0.39) and squamous cell carcinomas (RRR = 0.3; 95% CI, 0-0.51).
The number of actinic keratosis was 11% lower in the nicotinamide arm than in the placebo arm at 3 months (P = .01). This reduction increased to 14% at 6 months (P < .001), 20% at 9 months (P < .0001) and 13% at 12 months (P < .005).
“Interestingly, this reduction in skin cancers seemed to start as early as the first 3-month visit,” Damian said. “And when they stop taking their tablets after 12 months, the benefit was no longer seen. In other words, you need to continue to take the tablets in order for them to be effective.”
Damian added that the researchers followed-up with the patients for 6 months at the conclusion of their intervention and indicated that the number of skin cancers were the same in both arms.
The researchers also noted that although nicotinic acid — a different form of vitamin B3 — has previously been associated with headaches, flushing and low blood pressure, these adverse events were not observed with nicotinamide in this study.
“This is the first clear evidence that we can reduce skin cancers using a simple vitamin, together with sensible sun protection,” Damian said in a press release. “However, people at high risk of skin cancer will still need regular checkups with their doctor.” – by Anthony SanFilippo
Reference:
Martin AJ, et al. Abstract 9000. Scheduled for presentation at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.
Disclosure: The researchers report employment and consultant/advisory roles with, stock ownership in, and research funding from AbbVie, Amgen, Celgene, GlaxoSmithKline, Janssen, Kyowa Hakko Kirin, LEO Pharma, Lilly, Meda Pharmaceuticals, Montrose Medical, Merck, Novartis, Ramsay Health, Roche Pharma and Xoma.
Perspective
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Laura Y. McGirt, MD
Given its anti-inflammatory properties, nicotinamide (vitamin B3) has long been used across a variety of dermatologic diseases. This newest study not only effectively demonstrates reduction of nonmelanoma skin cancers in high-risk patients through the use of an oral medication, but it is also accomplished with nicotinamide, a widely available, well-tolerated and inexpensive vitamin. As skin cancer and its medical and economic toll continue to increase, it is exciting that a simple vitamin — along with continued sun protection and routine dermatologic examination — can significantly reduce the development of premalignant actinic keratoses, as well as basal cell and squamous cell carcinomas.
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