Martin et al recently presented a study at the 2015 American Society of Clinical Oncology Annual Meeting (J Clin Oncol. 2015;33[suppl]:9000) that reported on a phase 3 double-blind randomized trial to assess the use of oral nicotinamide to reduce actinic skin cancers, namely basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
This study was conducted in 2 tertiary treatment centers in Sydney, Australia, from 2012 to 2014, and it included 386 immunocompetent participants with 2 or more histologically confirmed nonmelanoma skin cancers (NMSCs) in the last 5 years. Two groups were randomized (1:1 ratio) to either receive oral nicotinamide 500 mg twice daily or matched placebo for 12 months. The primary end point measured was the number of new NMSCs to 12 months. Other secondary end points included number of SCCs, BCCs, and actinic keratoses to 12 months. Dermatologists performed skin checks every 3 months on the participants.
The results of the study showed that the average NMSC rate was significantly lower for the oral nicotinamide group (1.77) compared to the placebo group (2.42). The estimated relative rate reduction (RRR) was 0.23 (95% confidence interval [CI], 0.04-0.38; P=.02) adjusting for center and NMSC history, and 0.27 (95% CI, 0.05-0.44; P=.02) with no adjustment. The effects for BCC were comparable to SCC: BCC (RRR, 0.20; 95% CI, -0.06 to 0.39; P=.1) and SCC (RRR, 0.30; 95% CI, 0-0.51; P=.05). Additionally, actinic keratosis counts were reduced by 11% at 3 months (P=.01), 14% at 6 months (P<.001), 20% at 9 months (P<.0001), and 13% at 12 months (P<.005) for the oral nicotinamide group compared to the placebo group. There was no difference in the adverse event rates between the 2 groups.
What’s the issue?
This study reported the results of a double-blind randomized study of nicotinamide (vitamin B3) to reduce actinic cancer, called the ONTRAC (Oral Nicotinamide to Reduce Actinic Cancer) study, with favorable results for the use of oral nicotinamide, an inexpensive vitamin. There was a 20% reduction in BCC and a 30% reduction in SCC in the nicotinamide group compared to the group taking a placebo with no active ingredients. This study was conducted in a heavily sun-damaged group and it is postulated that nicotinamide helps cells repair DNA damage.
The thought of using a vitamin to reduce skin cancer rates is exciting; however, this study is singular, and while it did show promising results, the number of participants is not very large. There also was no evidence that nicotinamide prevents melanoma formation. Also, there was no protective effect seen once the vitamin B3 treatment was stopped. One must be cognizant that nicotinamide is not interchangeable with other forms of vitamin B3 such as niacin.
Although this study is promising, more research is needed to determine nicotinamide’s preventative effects. Of course, strict sun protection and skin checks are the first line in the prevention of skin cancer. Will you be prescribing oral nicotinamide to your patients to prevent NMSC?
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