Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial

Abstract

Abbreviations BCC = basal cell carcinoma; nBCC = nodular basal cell carcinoma sBCC = superficial basal cell carcinoma; PDT = photodynamic therapy RCT = randomised controlled trial Abstract -200 words Main text -2600 words Tables -1 Figures -1 References -23 2 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.

Five-Year Results of a Randomized Controlled Trial Comparing Effectiveness of Photodynamic Therapy, Topical Imiquimod, and Topical 5-Fluorouracil in Patients with Superficial Basal Cell Carcinoma

“…Basal cell carcinoma (BCC), the most common nonmelanoma skin cancer among the white population, is an important health problem worldwide and has a rapidly increasing incidence (Flohil et al, 2013;Lomas et al, 2012) As a result, BCC causes high medical consumption and health care costs (Housman et al, 2003). Although surgical excision is the gold standard for treatment of BCCs, different studies suggest that noninvasive therapies are useful alternatives to surgery for treatment of superficial BCC (sBCC) (Szeimies et al, 2008;Williams et al, 2017). Besides being less invasive, topical therapies also have other advantages like good cosmetic outcome, according to evaluation by physicians (Bath-Hextall et al, 2014;Cosgarea et al, 2013;Szeimies et al, 2008).…”

“…Only a few studies on long-term effectiveness of noninvasive treatment of sBCC have been published. Head-to-head studies are pivotal to reach consensus in international BCC guidelines on the first choice noninvasive treatment to compare effectiveness (Roozeboom et al, 2012;Williams et al, 2017). We previously showed that the efficacy of 5% imiquimod cream is superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in the treatment of sBCC at 3-year follow-up (Roozeboom et al, 2016).…”

Comparing treatments for basal cell carcinoma in terms of long‐term treatment‐failure: a network meta‐analysis

“…1. 11,[35][36][37][38][39][40][41][42][43][44][45][46][47] All 14 studies were written in the English language. The articles were published from 1986 to 2018.…”

Diagnosis and management of nonmelanoma skin cancer

“…There were similar cosmetic outcomes. 31 The main side-effects of the treatment are erythema, crusting, pain, flu-like symptoms and ulceration, which can be severe. Topical imiquimod is not recommended for high-risk BCC or SCC as recurrence rates are too high.…”