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Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice

Introduction: Locally advanced basal cell carcinoma (LA-BCC) is defined as that BCC in which there is radiological confirmation of invasion of certain neighboring structures in depth and also, usually, a BCC that is of a sufficient size and invasion (although there is no radiological demonstration o...

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Autores principales: Ruiz-Villaverde, Ricardo, Herrera-Acosta, Enrique, Ruiz de Casas, Andres, Villegas-Romero, Isabel M., Moreno-Suárez, Fátima G., Vílchez-Márquez, Francisco, Galán-Gutiérrez, Manuel, Vázquez-Bayo, Maria Carmen, Cases-Mérida, Sandra, Almazán-Fernández, Francisco M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10488851/
https://www.ncbi.nlm.nih.gov/pubmed/37685698
http://dx.doi.org/10.3390/jcm12175631
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author Ruiz-Villaverde, Ricardo
Herrera-Acosta, Enrique
Ruiz de Casas, Andres
Villegas-Romero, Isabel M.
Moreno-Suárez, Fátima G.
Vílchez-Márquez, Francisco
Galán-Gutiérrez, Manuel
Vázquez-Bayo, Maria Carmen
Cases-Mérida, Sandra
Almazán-Fernández, Francisco M.
author_facet Ruiz-Villaverde, Ricardo
Herrera-Acosta, Enrique
Ruiz de Casas, Andres
Villegas-Romero, Isabel M.
Moreno-Suárez, Fátima G.
Vílchez-Márquez, Francisco
Galán-Gutiérrez, Manuel
Vázquez-Bayo, Maria Carmen
Cases-Mérida, Sandra
Almazán-Fernández, Francisco M.
author_sort Ruiz-Villaverde, Ricardo
collection PubMed
description Introduction: Locally advanced basal cell carcinoma (LA-BCC) is defined as that BCC in which there is radiological confirmation of invasion of certain neighboring structures in depth and also, usually, a BCC that is of a sufficient size and invasion (although there is no radiological demonstration of deep invasion) in which surgery and radiotherapy are not adequate, are insufficient or are contraindicated to achieve the cure of the tumor, either due to characteristics of the tumor itself or of the patient. Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that is not amenable to curative surgery or radiotherapy. Material and methods: This is a retrospective, multicenter and descriptive study in nine centers in Andalusia, Spain. Patients treated with sonidegib for >3 months for locally advanced BCC were included from 1 January 2021 to 1 January 2023. Epidemiological, efficacy and safety data were collected. Results: In the present study, a total of 38 patients were included, with a median age of 76.23 years (range 40–101). Prior treatment was surgery (31.57%; n = 25), radiotherapy (15.78%; n = 6), vismodegib (31.57%; n = 12). Eleven patients had not received prior treatment. LA-BCC were located in the cephalic pole, face or scalp. There was a total response in 9/38 patients (23.7%), partial response in 25/38 patients (65.8%) and no response in 4 patients (10.52%). In 6/34 patients, the dose was reduced to 200 mg every other day until it was discontinued due to adverse effects. The main adverse effects reported were dysgeusia (n = 8), asthenia (n = 8), = 6), muscle spasms (n = 6), alopecia (n = 4) and gastrointestinal intolerance (n = 4). Discussion: Sonidegib is the second iHh authorized for the treatment of adult patients with locally advanced BCC who are not amenable to curative surgery or radiotherapy, based on the results of the phase II clinical trial, BOLT. Sonidegib shows good effectiveness and an acceptable safety profile in routine clinical practice in the sample presented.
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spelling pubmed-104888512023-09-09 Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice Ruiz-Villaverde, Ricardo Herrera-Acosta, Enrique Ruiz de Casas, Andres Villegas-Romero, Isabel M. Moreno-Suárez, Fátima G. Vílchez-Márquez, Francisco Galán-Gutiérrez, Manuel Vázquez-Bayo, Maria Carmen Cases-Mérida, Sandra Almazán-Fernández, Francisco M. J Clin Med Article Introduction: Locally advanced basal cell carcinoma (LA-BCC) is defined as that BCC in which there is radiological confirmation of invasion of certain neighboring structures in depth and also, usually, a BCC that is of a sufficient size and invasion (although there is no radiological demonstration of deep invasion) in which surgery and radiotherapy are not adequate, are insufficient or are contraindicated to achieve the cure of the tumor, either due to characteristics of the tumor itself or of the patient. Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that is not amenable to curative surgery or radiotherapy. Material and methods: This is a retrospective, multicenter and descriptive study in nine centers in Andalusia, Spain. Patients treated with sonidegib for >3 months for locally advanced BCC were included from 1 January 2021 to 1 January 2023. Epidemiological, efficacy and safety data were collected. Results: In the present study, a total of 38 patients were included, with a median age of 76.23 years (range 40–101). Prior treatment was surgery (31.57%; n = 25), radiotherapy (15.78%; n = 6), vismodegib (31.57%; n = 12). Eleven patients had not received prior treatment. LA-BCC were located in the cephalic pole, face or scalp. There was a total response in 9/38 patients (23.7%), partial response in 25/38 patients (65.8%) and no response in 4 patients (10.52%). In 6/34 patients, the dose was reduced to 200 mg every other day until it was discontinued due to adverse effects. The main adverse effects reported were dysgeusia (n = 8), asthenia (n = 8), = 6), muscle spasms (n = 6), alopecia (n = 4) and gastrointestinal intolerance (n = 4). Discussion: Sonidegib is the second iHh authorized for the treatment of adult patients with locally advanced BCC who are not amenable to curative surgery or radiotherapy, based on the results of the phase II clinical trial, BOLT. Sonidegib shows good effectiveness and an acceptable safety profile in routine clinical practice in the sample presented. MDPI 2023-08-29 /pmc/articles/PMC10488851/ /pubmed/37685698 http://dx.doi.org/10.3390/jcm12175631 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ruiz-Villaverde, Ricardo
Herrera-Acosta, Enrique
Ruiz de Casas, Andres
Villegas-Romero, Isabel M.
Moreno-Suárez, Fátima G.
Vílchez-Márquez, Francisco
Galán-Gutiérrez, Manuel
Vázquez-Bayo, Maria Carmen
Cases-Mérida, Sandra
Almazán-Fernández, Francisco M.
Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title_full Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title_fullStr Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title_full_unstemmed Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title_short Multicenter Retrospective Andalusian Study of the Use of Sonidegib for the Treatment of Local Advanced Basal Cell Carcinoma in Real Clinical Practice
title_sort multicenter retrospective andalusian study of the use of sonidegib for the treatment of local advanced basal cell carcinoma in real clinical practice
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10488851/
https://www.ncbi.nlm.nih.gov/pubmed/37685698
http://dx.doi.org/10.3390/jcm12175631
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