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Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients.
Allen, Nicholas C; Martin, Andrew J; Snaidr, Victoria A; Eggins, Renee; Chong, Alvin H; Fernandéz-Peñas, Pablo; Gin, Douglas; Sidhu, Shireen; Paddon, Vanessa L; Banney, Leith A; Lim, Adrian; Upjohn, Edward; Schaider, Helmut; Ganhewa, Aparna D; Nguyen, Jennifer; McKenzie, Catriona A; Prakash, Saurabh; McLean, Catriona; Lochhead, Alistair; Ibbetson, Jan; Dettrick, Andrew; Landgren, Anthony; Allnutt, Katherine J; Allison, Clare; Davenport, Rachael B; Mumford, Blake P; Wong, Brittany; Stagg, Brendan; Tedman, Alexander; Gribbin, Hannah; Edwards, Harrison A; De Rosa, Nicholas; Stewart, Thomas; Doolan, Brent J; Kok, Yonatan; Simpson, Kate; Low, Zhi M; Kovitwanichkanont, Tom; Scolyer, Richard A; Dhillon, Haryana M; Vardy, Janette L; Chadban, Steven J; Bowen, David G; Chen, Andrew C; Damian, Diona L.
Affiliation
  • Allen NC; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Martin AJ; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Snaidr VA; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Eggins R; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Chong AH; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Fernandéz-Peñas P; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Gin D; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Sidhu S; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Paddon VL; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Banney LA; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Lim A; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Upjohn E; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Schaider H; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Ganhewa AD; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Nguyen J; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • McKenzie CA; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Prakash S; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • McLean C; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Lochhead A; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Ibbetson J; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Dettrick A; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Landgren A; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Allnutt KJ; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Allison C; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Davenport RB; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Mumford BP; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Wong B; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Stagg B; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Tedman A; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Gribbin H; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Edwards HA; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • De Rosa N; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Stewart T; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Doolan BJ; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Kok Y; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Simpson K; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Low ZM; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Kovitwanichkanont T; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Scolyer RA; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Dhillon HM; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Vardy JL; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Chadban SJ; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Bowen DG; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Chen AC; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
  • Damian DL; From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and t
N Engl J Med ; 388(9): 804-812, 2023 Mar 02.
Article in En | MEDLINE | ID: mdl-36856616
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 11 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.).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Skin Neoplasms / Niacinamide / Transplant Recipients / Antineoplastic Agents Type of study: Clinical_trials / Etiology_studies Aspects: Patient_preference Limits: Humans Country/Region as subject: Oceania Language: En Journal: N Engl J Med Year: 2023 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Skin Neoplasms / Niacinamide / Transplant Recipients / Antineoplastic Agents Type of study: Clinical_trials / Etiology_studies Aspects: Patient_preference Limits: Humans Country/Region as subject: Oceania Language: En Journal: N Engl J Med Year: 2023 Document type: Article