Premium
Risk of basal cell carcinoma in a randomized clinical trial of aspirin and folic acid for the prevention of colorectal adenomas
Author(s) -
Passarelli M.N.,
Barry E.L.,
Zhang D.,
Gangar P.,
Rees J.R.,
Bresalier R.S.,
McKeownEyssen G.,
Karagas M.R.,
Baron J.A.
Publication year - 2018
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.16571
Subject(s) - aspirin , medicine , folic acid , colorectal cancer , randomized controlled trial , oncology , gastroenterology , cancer
Summary Background Aspirin may reduce the risk of several types of cancer. Objectives To evaluate if folic acid is associated with risk of basal cell carcinoma ( BCC ). Methods BCC incidence was evaluated in a randomized, double‐blind, placebo‐controlled clinical trial of aspirin (81 mg daily or 325 mg daily for ~3 years) and/or folic acid (1 mg daily for ~6 years) for the prevention of colorectal adenomas among 1121 participants with a previous adenoma. BCC was confirmed by blinded review of pathology reports. Results One hundred and four of 958 non‐Hispanic white participants were diagnosed with BCC over a median follow‐up of 13·5 years. Cumulative incidence of BCC was 12% [95% confidence interval ( CI ) 7–17] for placebo, 16% (95% CI 11–21) for 81 mg aspirin daily and 15% (95% CI 10–20) for 325 mg aspirin daily [hazard ratio ( HR ) for any aspirin 1·45 (95% CI 0·93–2·26); HR for 81 mg daily 1·57 (95% CI 0·96–2·56); HR for 325 mg daily 1·33 (95% CI 0·80–2·20)]. BCC risk was higher with aspirin use in those without previous skin cancer but lower with aspirin use in those with previous skin cancer ( P interaction = 0·02 for 81 mg aspirin daily; P interaction = 0·03 for 325 mg aspirin daily). Folic acid supplementation was unrelated to BCC incidence ( HR 0·85; 95% CI 0·57–1·27). Conclusions Neither aspirin nor folic acid treatment had a statistically significant effect on risk of BCC . Subgroup analysis suggested that chemopreventive effects of nonsteroidal anti‐inflammatory drugs may be specific to those at high risk for BCC .