Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients

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#humans #australia #basal-cell-carcinoma #carcinoma-squamous-cell #chemoprevention

Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients

Allen et al., 2023 | N Engl J Med | Rct

Citation

Allen Nicholas C, Martin Andrew J, ... Damian Diona L. Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients. N Engl J Med. 2023-Mar-02;388(9):804-812. doi:10.1056/NEJMoa2203086

Abstract

BACKGROUND: Immunosuppressed organ-transplant recipients have an increased incidence of, and mortality from, skin cancer. Nicotinamide (vitamin B3) enhances the repair of ultraviolet (UV) radiation-induced DNA damage, reduces the cutaneous immunosuppressive effects of UV radiation, and reduces the incidence of keratinocyte cancers (including squamous-cell and basal-cell carcinomas) and actinic keratoses among high-risk immunocompetent patients. Whether oral nicotinamide is useful for skin-cancer chemoprevention in organ-transplant recipients is unclear. 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.).

Key Findings

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 observe

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 158
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Australia
  • Basal Cell Carcinoma
  • Carcinoma, Squamous Cell
  • Chemoprevention
  • Keratosis, Actinic
  • Niacinamide
  • Quality of Life
  • Skin Neoplasms
  • Transplant Recipients
  • Immunocompromised Host
  • Organ Transplantation
  • Antineoplastic Agents
  • Ultraviolet Rays

Evidence Classification

  • Level: Rct
  • Publication Types: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: niacin-skin

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09