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Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients

Among 158 immunosuppressed solid-organ transplant recipients, oral nicotinamide therapy did not lower the numbers of keratinocyte cancers or actinic keratoses over a 1-year period.

In a 12-month, placebo-controlled trial, participants who had had at least 2 keratinocyte cancers in the past 5 years received nicotinamide 500 mg or placebo twice daily for 12 months. Based on a primary endpoint of the number of new keratinocyte cancers during the 12-month intervention period, the study showed the following: “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.”

Editorial: “Emphasizing the importance of lifelong sun-protective practices for persons with sun-sensitive phenotypes is imperative in reducing pretransplantation risk,” editorialists write. “Immunopreventive strategies with immune checkpoint inhibitors before transplantation in the highest-risk patients have yet to be explored; nevertheless, given the activity of immunotherapy in nonmelanoma skin cancers, such approaches should be thoughtfully considered in a stepwise fashion. For example, an initial investigation, similar in design to the ONTRAC trial, could evaluate the effectiveness of immune checkpoint inhibitors in decreasing the development of new keratinocyte carcinomas in patients with a history of multiple nonmelanoma skin cancers. If an efficacy signal was established, especially if such an approach decreased the further development of skin cancers after the cessation of immunotherapy, a follow-up study to evaluate an immunopreventive strategy in patients before transplantation would be warranted. Finally, innovative regimens that are designed to minimize or even completely abrogate the need for immunosuppression in the allograft recipient (known as transplant-organ tolerance) may preserve antitumor immunity and dramatically decrease the risk of skin cancer in this population.”

Source: New England Journal of Medicine