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

Williams, Hywel C. and Bath-Hextall, Fiona and Ozolins, Mara and Armstrong, Sarah J. and Colver, Graham B. and Perkins, William and Miller, Paul S.J. (2016) 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). pp. 614-619. ISSN 1523-1747

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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.

Item Type: Article
Additional Information: Written on behalf of the Surgery versus Imiquimod for Nodular and Superficial basal cell carcinoma (SINS) study group.
Keywords: Basal cell carcinoma; BCC; imiquimod; surgery; non-inferiority study; randomised controlled trial
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Health Sciences
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine
Identification Number: https://doi.org/10.1016/j.jid.2016.10.019
Depositing User: Eprints, Support
Date Deposited: 19 Oct 2016 08:50
Last Modified: 24 Feb 2017 20:30
URI: http://eprints.nottingham.ac.uk/id/eprint/37715

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