Williams, Hywel C., Bath-Hextall, Fiona, Ozolins, Mara, Armstrong, Sarah J., Colver, Graham B., 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
Full text not available from this repository.
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
|
| RIS ID: |
https://nottingham-repository.worktribe.com/output/836613 |
| 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: |
10.1016/j.jid.2016.10.019 |
| Depositing User: |
Eprints, Support
|
| Date Deposited: |
19 Oct 2016 08:50 |
| Last Modified: |
15 Aug 2024 15:21 |
| URI: |
https://eprints.nottingham.ac.uk/id/eprint/37715 |
Actions (Archive Staff Only)
 |
Edit View |
Tools
Tools
