Fax: (507) 284-1803
Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251)
Article first published online: 31 AUG 2011
Copyright © 2011 American Cancer Society
Volume 118, Issue 8, pages 2128–2137, 15 April 2012
How to Cite
Kadakia, K. C., Barton, D. L., Loprinzi, C. L., Sloan, J. A., Otley, C. C., Diekmann, B. B., Novotny, P. J., Alberts, S. R., Limburg, P. J. and Pittelkow, M. R. (2012), Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251). Cancer, 118: 2128–2137. doi: 10.1002/cncr.26374
- Issue published online: 6 APR 2012
- Article first published online: 31 AUG 2011
- Manuscript Accepted: 31 MAY 2011
- Manuscript Revised: 28 MAY 2011
- Manuscript Received: 15 APR 2011
- basal cell carcinoma;
- squamous cell carcinoma;
- clinical trials
Chemoprevention with systemic retinoids has demonstrated promise in decreasing the incidence of new primary nonmelanoma skin cancers (NMSCs) in immunocompromised post-transplantation recipients. There is limited evidence for the use of systemic retinoids in the nontransplantation patient. To the authors' knowledge, this is the first randomized controlled trial to assess the efficacy of acitretin as a chemopreventive agent in nontransplantation patients at high-risk for NMSC.
The study was designed as a prospective, randomized, double-blind, placebo-controlled clinical trial. To test the possible skin cancer-preventing effect of a 2-year treatment with acitretin, 70 nontransplantation patients aged ≥18 years who had a history of ≥2 NMSCs within 5 years of trial onset were randomized to receive either placebo or acitretin 25 mg orally 5 days per week. The primary outcome measure was the rate of new NMSC development.
Seventy patients were randomized to receive either acitretin alone (N = 35) or placebo (N = 35). During the 2-year treatment period, the patients who received acitretin did not have a statistically significant reduction in the rate of new primary NMSCs (odds ratio, 0.41; 95% confidence interval, 0.15-1.13; 54% vs 74%; P = .13). However, using the incidence of new NMSC, the time to new NMSC, and total NMSC counts, an umbrella test indicated a significant trend that favored the use of acitretin (chi-square statistic, 3.94; P = .047). The patients who received acitretin reported significantly more mucositis and skin toxicities compared with the patients who received placebo.
Although there was not a statistically significant benefit observed with the use of acitretin, this may have been the result of low statistical power. Cancer 2012;. © 2011 American Cancer Society.