Surgery Versus 5% Imiquimod for Nodularand Superficial Basal Cell Carcinoma: 5-Year Results of the SINSRandomized 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

© 2016 The Authors We previously reported modest clinical 3-year benefit for topical imiquimod compared with surgery for superficial or nodular basal cell carcinoma at low-risk sites in our noninferiority randomized controlled SINS trial. Here we report 5-year data. Participants were randomized to imiquimod 5% cream once daily (superficial basal cell carcinoma, 6 weeks; nodular basal cell carcinoma, 12 weeks) or excisional surgery (4-mm margin). The primary outcome was clinical absence of initial failure or signs of recurrence at the 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. Of 501 participants randomized, 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 with 97.7% (173/177) for surgery (relative risk of imiquimod success= 0.84, 95% confidence interval= 0.77–0.91, 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 1. Although surgery is clearly superior to imiquimod, this study shows sustained benefit for lesions that respond early to topical imiquimod.

• 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.