KEY TAKEAWAYS
- The study aimed to assess clinical factors influencing complete response in Sonidegib-treated patients with laBCC.
- The primary endpoint was ORR.
- The study found no significant association between clinical response and Sonidegib alternate dose regimen in ORR analysis.
G Spallone and the team aimed to assess clinical factors influencing complete response in Sonidegib-treated locally advanced basal cell carcinoma (laBCC). Hedgehog pathway inhibitors, including Vismodegib and Sonidegib, are approved for systemic laBCC treatment. The primary endpoint in trials for both drugs was objective response rate (ORR).
The study included adult patients with laBCC treated with Sonidegib at the Dermato-Oncology Unit of IFO San Gallicano from June 2020 to September 2022. Data on patient, tumor, and treatment characteristics were collected.
The primary outcome was the complete response rate, with secondary outcomes including median time to the best response and complete response. Treatment-related adverse events (TRAEs) and dose adjustments were also documented.
The results revealed that, among the 19 patients analyzed, 8 (42.1%) achieved a complete response, 7 (36.8%) experienced a partial response, and 4 (21%) encountered progressive disease. The median time to the best response was 3 months for patients with a partial response (range 2.0-4.0, with 3 patients not evaluable) and 3.5 months for those with a complete response (range 2-5).
TRAEs were observed in 14 (73.6%) patients, with 8 (57.1%) reporting ≤2 TRAE categories and 6 (42.8%) reporting >2. Approximately 78.9% of patients underwent a modified treatment schedule. Furthermore, 12.5% of patients who achieved a complete response received the full dosage throughout treatment, compared to 27.3% of those with a partial response.
The study found no statistically significant association between the clinical outcome of interest, ORR, and clinicopathological or treatment characteristics. The analysis confirmed no statistically significant correlation between clinical response and Sonidegib alternate dose regimen.
Research was funded by the Italian Ministry of Health.
Source: https://pubmed.ncbi.nlm.nih.gov/38639529/
Spallone G, Carbone A, Sperati F, et al. (2024) “Clinical determinants of clinical response to Sonidegib in advanced basal cell carcinoma: a monocenter experience.” Eur Rev Med Pharmacol Sci. 2024 Apr;28(7):2923-2928. doi: 10.26355/eurrev_202404_35923. PMID: 38639529.
