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 (laBCC) or multiple (mBCC) basal cell carcinomas, characterized by complex surgical histories and comorbidities. The objective response was that 53% of patients achieved complete response, 29% partial response and 18% stable disease, with no documented progression during treatment (mean 7.3 months). Sonidegib showed significant efficacy in mBCC, with a mean reduction of 3.89 lesions per patient. Key findings indicate that prior surgery correlates with poorer response, while sonidegib effectively 'clears the field' of subclinical lesions. The safety profile was favourable, with predominantly mild and manageable adverse events. Despite the limited sample size, our findings confirm the significant efficacy of sonidegib in a frail pretreated population with multiple comorbidities. This study supports the use of sonidegib as a valuable therapeutic strategy for complex patients with high tumour burden or those ineligible for further surgery.