Posted: Friday, February 4, 2022
A recent article published in the Journal of the American Academy of Dermatology reported findings from a study examining the efficacy and tolerability of sonidegib, a Hedgehog pathway inhibitor used to treat advanced basal cell carcinoma. Massimiliano Scalvenzi, MD, of the University of Naples Federico II, Italy, and colleagues examined whether patients achieved a complete, partial, or no response following sonidegib treatment. Their findings revealed that after 5.6 months of follow-up, at least 89.6% patients who achieved a complete response were free of recurrence. They also noted that their real-life data reported a higher therapeutic response than previous clinical trials.
A total of 54 patients (38 men and 16 women) with basal cell carcinoma were treated with sonidegib at the approved dosage of 200 mg daily. The diameter, localization, and histologic subtype of the largest (target) lesion were recorded, and patients were visited every month for laboratory tests and recording of any adverse events. The primary objective was to examine the therapeutic response, defined as complete response, clinical absence of all lesions; partial response, greater than 30% clinical reduction of the target lesion; and no response, less than 30% clinical reduction of the target lesion. Secondary objectives were the time to complete response and recurrence-free survival.
Findings revealed that 29 patients (53.7%) achieved a complete response, 21 (38.9%) achieved a partial response, and 4 had no response. Patients with a complete response were treated for a median of 7 months, with a median follow-up of 5.6 months. During follow-up, 26 patients (89.6%) remained free of recurrence, whereas 3 patients (10.4%) experienced recurrence.
Based on these results, Dr. Scalvenzi and colleagues concluded that their findings indicate the long-term efficacy and tolerability of sonidegib. However, they also acknowledged that several limitations of their retrospective design warrant further research.
Disclosure: The study authors reported no conflicts of interest.
Journal of the American Academy of Dermatology