Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial

Williams, Hywel C.; Bath-Hextall, Fiona; Ozolins, Mara; Armstrong, Sarah J.; Colver, Graham B.; Perkins, William; Miller, Paul S.J.; Surgery versus Imiquimod forNodular and Superficial basal cell carcinoma (SINS) study group

Abstract

Background: We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma (sBCC, nBCC) at low risk sites in our non-inferiority randomised controlled SINS trial. Here we report 5-year data. Methods: Participants were randomised to imiquimod 5% cream once daily (sBCC, 6 weeks; nBCC, 12 weeks) or excisional surgery (4 mm margin). Primary outcome was clinical absence of initial failure or signs of recurrence at 3 year dermatology review. Five year success was defined as 3 year success plus absence of recurrences identified through hospital, histopathology and general practitioner records.
Results: Of 501 participants randomised, 401 contributed to the modified intention-to-treat analyses at year 3 (primary outcome), 383 (96%) of whom had data at year 5. Five year success rates for imiquimod were 82·5% (170/206) compared to 97·7% (173/177) for surgery (relative risk of imiquimod success 0·84, 95% CI 0·77 to 0·91, p<0.001). These were comparable to year 3 success rates of 83·6% (178/213) and 98.4% (185/188), for imiquimod and surgery, respectively. Most imiquimod treatment failures occurred in year one.
Interpretation: Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod.

Citation

Williams, H. C., Bath-Hextall, F., Ozolins, M., Armstrong, S. J., Colver, G. B., Perkins, W., Miller, P. S., & Surgery versus Imiquimod forNodular and Superficial basal cell carcinoma (SINS) study group. (2017). Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial. Journal of Investigative Dermatology, 137(3), 614-619. https://doi.org/10.1016/j.jid.2016.10.019

• Journal Article Type: Article
• Acceptance Date: Oct 6, 2016
• Online Publication Date: Dec 5, 2016
• Publication Date: Mar 1, 2017
• Deposit Date: Oct 19, 2016
• Publicly Available Date: Dec 5, 2016
• Journal: Journal of Investigative Dermatology
• Print ISSN: 0022-202X
• Electronic ISSN: 1523-1747
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 137
• Issue: 3
• Pages: 614-619
• DOI: https://doi.org/10.1016/j.jid.2016.10.019
• Keywords: Basal cell carcinoma; BCC; imiquimod; surgery; non-inferiority study; randomised controlled trial
• Public URL: https://nottingham-repository.worktribe.com/output/836613
• Publisher URL: http://www.sciencedirect.com/science/article/pii/S0022202X16325386
• Additional Information: This article is maintained by: Elsevier; Article Title: Surgery Versus 5% Imiquimod for Nodularand Superficial Basal Cell Carcinoma: 5-Year Results of the SINSRandomized Controlled Trial; Journal Title: Journal of Investigative Dermatology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.jid.2016.10.019; Content Type: article; Copyright: © 2016 The Authors. Published by Elsevier, Inc. on behalf of the Society for Investigative Dermatology.
• Contract Date: Oct 19, 2016