Real-world efficacy and safety of Sonidegib in Locally Advanced and Multiple Basal Cell Carcinomas: A Monocentric Prospective Observational Study

This monocentric study evaluated the real-world efficacy and safety of Sonidegib in 17 patients with locally advanced or multiple basal cell carcinomas (laBCC/mBCC), characterized by complex surgical histories and comorbidities. The objective response rate was 52.9% of patients achieved Complete Response, 29.4% Partial Response, and 17.7% Stable Disease, with no documented progression during treatment (mean 7.3 months). Sonidegib showed significant efficacy in multiple BCCs, with a mean reduction of 3.89 lesions per patient. Key findings indicate prior surgery correlates with poorer response, while Sonidegib effectively 'clears the field' of subclinical lesions. The safety profile was favorable, with predominantly mild and manageable adverse events. Despite the limited sample size, our findings confirm the significant efficacy of Sonidegib in a frail, pre-treated population with multiple comorbidities. This study supports its use as a valuable therapeutic strategy for complex patients with high tumor burden or those ineligible for further surgery.