1. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial
- Author
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Ahmady, Shima, Jansen, Maud H E, Nelemans, Patty J, Kessels, Janneke P H M, Arits, Aimee H M M, de Rooij, Michette J M, Essers, Brigitte A B, Quaedvlieg, Patricia J F, Kelleners-Smeets, Nicole W J, Mosterd, Klara, Ahmady, Shima, Jansen, Maud H E, Nelemans, Patty J, Kessels, Janneke P H M, Arits, Aimee H M M, de Rooij, Michette J M, Essers, Brigitte A B, Quaedvlieg, Patricia J F, Kelleners-Smeets, Nicole W J, and Mosterd, Klara
- Abstract
Importance: Treatment of actinic keratosis (AK) aims to prevent cutaneous squamous cell carcinoma (cSCC). However, whether AK can progress into invasive cSCC is a matter of debate, and little is known about the effect of treatment on preventing cSCC.Objectives: To evaluate the risk of invasive cSCC and factors that may contribute to increased risk in patients with multiple AKs.Design, Setting, and Participants: In this secondary analysis of a multicenter randomized clinical trial, 624 patients with a minimum of 5 AKs within an area of 25 to 100 cm2 on the head were recruited from the Department of Dermatology of 4 hospitals in the Netherlands. Long-term follow-up was performed from July 1, 2019, to December 31, 2020.Interventions: Patients were randomized to treatment with 5% fluorouracil, 5% imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015% ingenol mebutate gel.Main Outcomes and Measures: The primary outcome was the proportion of patients with invasive cSCC in the target area during follow-up. Secondary outcomes were the associations between risk of invasive cSCC and a priori defined potential prognostic factors, including type of treatment, severity of AK (Olsen grade), history of nonmelanoma skin cancer, and additional treatment.Results: Of the 624 patients (558 [89.4%] male; median age, 73 years [range, 48-94 years]) in the study, 26 were diagnosed with a histologically proven invasive cSCC in the target area during follow-up. The total 4-year risk of developing cSCC in a previously treated area of AK was 3.7% (95% CI, 2.4%-5.7%), varying from 2.2% (95% CI, 0.7%-6.6%) in patients treated with fluorouracil to 5.8% (95% CI, 2.9%-11.3%) in patients treated with imiquimod. In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment.Conclusions and Relevan
- Published
- 2022