The goal of this clinical trial is to evaluate the safety, tolerability, and clinical outcomes of a dose-modulation strategy of Sonidegib in adult patients with locally advanced periocular basal cell carcinoma (laBCC) who are not candidates for surgery or radiotherapy. The main questions it aims to answer are: * Can dose-adjusted Sonidegib treatment preserve ocular function and avoid disfiguring surgery in laBCC patients? * What is the rate of tumor response, recurrence, and adverse events during dose-modulated treatment? Researchers will compare different dosing regimens based on treatment response, tolerability, and toxicity profiles to assess whether intermittent dosing or dose reductions can maintain clinical benefits while minimizing adverse effects. This monocentric retrospective observational real-world evidence (RWE) study included 12 patients (8 male, 4 female; aged between 67 and 92 years; mean 83.25 years) with histologically confirmed periocular laBCC (staged T3-T4b) treated with sonidegib between 2021-2023 at the Oculoplasty Unit of the University of Naples Federico II. Eligible patients were those for whom conventional surgery or radiotherapy would result in loss of vision or unacceptable cosmetic outcomes. Participants: * Took Sonidegib orally, starting at 200 mg daily, with possible dose interruptions or reductions based on individual tolerance and tumor response. * Underwent clinical and ophthalmologic evaluations every 4-6 weeks. * Had imaging and dermatologic assessments to monitor tumor regression. * Completed follow-up visits after treatment completion to assess long-term control and safety. The results of this study aim to support an eye-sparing, patient-centered approach for complex periocular tumors.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Tumor Control Rate
Timeframe: From baseline to end of follow-up (ranging from 12 to 33 months)