HYWEL WILLIAMS HYWEL.WILLIAMS@NOTTINGHAM.AC.UK
Professor of Dermato-Epidemiology
HYWEL WILLIAMS HYWEL.WILLIAMS@NOTTINGHAM.AC.UK
Professor of Dermato-Epidemiology
Fiona Bath-Hextall
Mara Ozolins
Sarah J. Armstrong
Graham B. Colver
William Perkins
Paul S.J. Miller
Surgery versus Imiquimod forNodular and Superficial basal cell carcinoma (SINS) study group
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.
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 |
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Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0
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