title: Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial.
abstract: 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.
authors.affiliation: Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK. Electronic address: Hywel.williams@nottingham.ac.uk.
authors.forename: Hywel C
authors.initials: HC
authors.lastname: Williams
authors.affiliation: Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK; School of Health Sciences University of Nottingham, Nottingham, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Bath-Hextall
authors.affiliation: Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK; NIHR Nottingham Hearing Biomedical Research Unit, University of Nottingham, Nottingham, UK.
authors.forename: Mara
authors.initials: M
authors.lastname: Ozolins
authors.affiliation: School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Armstrong
authors.affiliation: Department of Dermatology, Chesterfield Royal Hospital NHS Foundation Trust, Chesterfield, UK.
authors.forename: Graham B
authors.initials: GB
authors.lastname: Colver
authors.affiliation: Department of Dermatology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
authors.forename: William
authors.initials: W
authors.lastname: Perkins
authors.affiliation: School of Medicine, University of Nottingham, Nottingham, UK.
authors.forename: Paul S J
authors.initials: PSJ
authors.lastname: Miller
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000188:drug therapy* / Q000601:surgery*; D002648:Child; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D055815:Young Adult
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod