Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial
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...
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| Format: | Article |
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Elsevier
2016
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| Online Access: | https://eprints.nottingham.ac.uk/37715/ |
| _version_ | 1848795518031888384 |
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| author | Williams, Hywel C. Bath-Hextall, Fiona Ozolins, Mara Armstrong, Sarah J. Colver, Graham B. Perkins, William Miller, Paul S.J. |
| author_facet | Williams, Hywel C. Bath-Hextall, Fiona Ozolins, Mara Armstrong, Sarah J. Colver, Graham B. Perkins, William Miller, Paul S.J. |
| author_sort | Williams, Hywel C. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T19:33:21Z |
| format | Article |
| id | nottingham-37715 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:33:21Z |
| publishDate | 2016 |
| publisher | Elsevier |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-377152024-08-15T15:21:20Z https://eprints.nottingham.ac.uk/37715/ 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. 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. Elsevier 2016-12-05 Article PeerReviewed 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 Basal cell carcinoma; BCC; imiquimod; surgery; non-inferiority study; randomised controlled trial http://www.sciencedirect.com/science/article/pii/S0022202X16325386 doi:10.1016/j.jid.2016.10.019 doi:10.1016/j.jid.2016.10.019 |
| spellingShingle | Basal cell carcinoma; BCC; imiquimod; surgery; non-inferiority study; 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 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title | Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title_full | Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title_fullStr | Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title_full_unstemmed | Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title_short | Surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the SINS randomised controlled trial |
| title_sort | surgery versus 5% imiquimod for nodular and superficial basal-cell carcinoma: five year results of the sins randomised controlled trial |
| topic | Basal cell carcinoma; BCC; imiquimod; surgery; non-inferiority study; randomised controlled trial |
| url | https://eprints.nottingham.ac.uk/37715/ https://eprints.nottingham.ac.uk/37715/ https://eprints.nottingham.ac.uk/37715/ |