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Management of advanced basal cell carcinoma with hedgehog inhibitors: a real-world prospective comparative study
Federico Venturi1,2,3, Biancamaria Zuccaro1, Gabriella Perillo1
1Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.
Background:
Hedgehog inhibitors (HHIs) should be offered to patients with advanced basal cell carcinoma (BCC) as a first-line treatment. Two systemic HHIs are currently available: sonidegib and vismodegib.
Objectives:
As there is no head-to-head trial of sonidegib vs. vismodegib and very few comparative studies have been published, we aimed to prospectively describe our long-term approach to managing advanced BCC based on our 10 years of experience with HHIs.
Methods:
We undertook a prospective, monocentric and descriptive study in Florence, Italy. Patients who were treated with sonidegib and/or vismodegib for advanced BCC according to the European Association of Dermato-Oncology staging system were included from January 2013 to December 2023. Epidemiological, efficacy and safety data were collected.
Results:
The study population consisted of 66 patients with a clinicopathologically confirmed diagnosis of advanced BCC. Of the 66 patients, 40 (61%) were treated with vismodegib, 19 (29%) received sonidegib and 7 (11%) were switched to sonidegib after vismodegib discontinuation. Among the 40 evaluable vismodegib-treated patients, the overall response rate (ORR) was 65%, with complete response (CR) in 28% of cases. The disease control rate was 85%. Among the 19 evaluable patients treated with sonidegib, the ORR and CR rates were 89% and 37%, respectively. Regarding patients who switched from vismodegib to sonidegib (mainly patients who had adverse events with vismodegib previously), the ORR was 71%, with CR in 43% of cases.
Conclusions:
The efficacy demonstrated by sonidegib is greater than reported in the pivotal studies, with an ORR of 89% (vs. 60.6%), a CR rate of 37% (vs. 22.7%) and a PR rate of 53% (vs. 37.9%). Another element of innovation was the analysis of the subgroup of patients who switched from vismodegib to sonidegib, with an ORR of 71% (CR 43%, PR 29%). This, in relation to the possibility of developing resistance during therapy with HHIs, represents a promising result, suggesting a maintenance of effectiveness of the target therapy even in patients who are not naive to it.
Insights
Sonidegib demonstrates superior efficacy in treating advanced basal cell carcinoma (BCC) compared to vismodegib, with higher response rates. This study also shows sonidegib remains effective even when patients switch from vismodegib.
Area of Science:
- Oncology
- Dermatology
- Pharmacology
Background:
- Advanced basal cell carcinoma (BCC) management relies on Hedgehog Pathway Inhibitors (HHIs).
- Sonidegib and vismodegib are the two available systemic HHIs for advanced BCC.
- Limited head-to-head trials necessitate further comparative studies.
Purpose of the Study:
- To prospectively describe a long-term management strategy for advanced BCC.
- To evaluate the clinical experience with sonidegib and vismodegib over 10 years.
- To provide insights into HHI treatment approaches based on real-world data.
Main Methods:
- A prospective, monocentric, descriptive study conducted in Florence, Italy.
- Inclusion of patients with advanced BCC treated with sonidegib and/or vismodegib (Jan 2013-Dec 2023).
- Collection of epidemiological, efficacy, and safety data.
Main Results:
- 66 patients with advanced BCC were analyzed.
- Sonidegib showed a higher Overall Response Rate (ORR) of 89.5% and Complete Response (CR) rate of 36.8%.
- Patients switched from vismodegib to sonidegib maintained high efficacy (ORR 71.4%, CR 42.9%).
Conclusions:
- Sonidegib exhibits greater efficacy than previously reported in pivotal trials for advanced BCC.
- Switching to sonidegib is a viable option for patients experiencing adverse events or potential resistance to vismodegib.
- Sonidegib offers sustained therapeutic effectiveness, even in patients previously treated with other HHIs.
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