Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma
Authors: Sinx K et al.
Summary: This report presents the one-year results of a phase 3, noninferiority, randomized, controlled trial assessing surgery compared to curettage/imiquimod for nodular BCC (ClinicalTrials.gov identifier NCT02242929). A total of 145 patients with primary histologically proven nodular BCC with a diameter ≥ 4mm and ≤ 20mm were enrolled and randomised to treatment at the Maastricht University Medical Centre, Maastricht, The Netherlands, with either standard surgical elliptical excision including a 3 mm clinically tumour-free margin (n=72) or partial tumour debulking under local anaesthesia with a blunt curette followed by a six-week period of topical imiquimod 5% (n=73) administered five days a week. At 12 months curettage/ imiquimod failed to meet the primary endpoint prespecified non-inferiority margin of -8% compared to surgery (recurrence-free rates, 86.3% vs 100%; treatment difference, -13.7%; 95% confidence interval, -21.6% to-5.8; 1-sided p=0.0004) and surgery therefore remains the gold standard for the treatment of nodular BC. The authors commented that while curettage and imiquimod cannot replace surgical excision for nodular BCC it provides a high efficacy treatment and is an option to prevent surgery overuse.
Comment: Imiquimod cream is a useful option for superficial BCC and has been shown in small studies to have a significant cure rate in thin nodular BCCs. This study compared nodular BCCs treated with combined curettage and imiquimod versus excision. Imiquimod was started one week after curettage and used for the traditional five days per week for a six-week regimen. At 12-months the combination of cream and curettage was inferior to surgery (not shown to be non-inferior). Patients and observers reported improved cosmesis particularly on the head and neck. Whilst surgery was shown to be superior for clearance at 12- months imiquimod after curettage may be a useful technique in selected cases.
Reference: J Am Acad Dermatol 2020;83(2):469-76
Summary: This report presents the one-year results of a phase 3, noninferiority, randomized, controlled trial assessing surgery compared to curettage/imiquimod for nodular BCC (ClinicalTrials.gov identifier NCT02242929). A total of 145 patients with primary histologically proven nodular BCC with a diameter ≥ 4mm and ≤ 20mm were enrolled and randomised to treatment at the Maastricht University Medical Centre, Maastricht, The Netherlands, with either standard surgical elliptical excision including a 3 mm clinically tumour-free margin (n=72) or partial tumour debulking under local anaesthesia with a blunt curette followed by a six-week period of topical imiquimod 5% (n=73) administered five days a week. At 12 months curettage/ imiquimod failed to meet the primary endpoint prespecified non-inferiority margin of -8% compared to surgery (recurrence-free rates, 86.3% vs 100%; treatment difference, -13.7%; 95% confidence interval, -21.6% to-5.8; 1-sided p=0.0004) and surgery therefore remains the gold standard for the treatment of nodular BC. The authors commented that while curettage and imiquimod cannot replace surgical excision for nodular BCC it provides a high efficacy treatment and is an option to prevent surgery overuse.
Comment: Imiquimod cream is a useful option for superficial BCC and has been shown in small studies to have a significant cure rate in thin nodular BCCs. This study compared nodular BCCs treated with combined curettage and imiquimod versus excision. Imiquimod was started one week after curettage and used for the traditional five days per week for a six-week regimen. At 12-months the combination of cream and curettage was inferior to surgery (not shown to be non-inferior). Patients and observers reported improved cosmesis particularly on the head and neck. Whilst surgery was shown to be superior for clearance at 12- months imiquimod after curettage may be a useful technique in selected cases.
Reference: J Am Acad Dermatol 2020;83(2):469-76