Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study

BRAF and MEK inhibitor, dabrafenib plus trametinib, adjuvant therapy is effective for high-risk resected melanoma patients with BRAF-V600 mutations. However, real-world evidence is limited. We aimed to determine the feasibility of this therapy in routine clinical practice. DESCRIBE-AD, a retrospecti...

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Autores: Manzano, José L., Martin Liberal, Juan, Fernández Morales, Luis A., Benítez, Gretel, Medina Martínez, Javier, Quindós, María, García Castaño, Almudena, Fernández, Ovidio, Simo, Rocío V., Majem, Margarita, Bellido, Lorena, Ayala de Miguel, Pablo, Campos Bonilla, Begoña, Espinosa, Enrique, Macías Cerrolaza, José A., Gil Arnaiz, Irene, Lorente, David, Rodriguez Lescure, Alvaro, Perez, Victor N., López Castro, Rafael, Gramaje, María G., Puértolas, Teresa, Rodriguez Moreno, Juan F., Espasa Font, Laia, Belaustegui Ferrández, Guillermo, Cerezuela Fuentes, Pablo
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/205363
Acesso em linha:https://hdl.handle.net/2445/205363
Access Level:acceso abierto
Palavra-chave:Tractament adjuvant del càncer
Melanoma
Adjuvant treatment of cancer
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spelling Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational studyManzano, José L.Martin Liberal, JuanFernández Morales, Luis A.Benítez, GretelMedina Martínez, JavierQuindós, MaríaGarcía Castaño, AlmudenaFernández, OvidioSimo, Rocío V.Majem, MargaritaBellido, LorenaAyala de Miguel, PabloCampos Bonilla, BegoñaEspinosa, EnriqueMacías Cerrolaza, José A.Gil Arnaiz, IreneLorente, DavidRodriguez Lescure, AlvaroPerez, Victor N.López Castro, RafaelGramaje, María G.Puértolas, TeresaRodriguez Moreno, Juan F.Espasa Font, LaiaBelaustegui Ferrández, GuillermoCerezuela Fuentes, PabloTractament adjuvant del càncerMelanomaAdjuvant treatment of cancerMelanomaBRAF and MEK inhibitor, dabrafenib plus trametinib, adjuvant therapy is effective for high-risk resected melanoma patients with BRAF-V600 mutations. However, real-world evidence is limited. We aimed to determine the feasibility of this therapy in routine clinical practice. DESCRIBE-AD, a retrospective observational study, collected real-world data from 25 hospitals in Spain. Histologically confirmed and resected BRAF-mutated melanoma patients aged & GE;18 years who were previously treated with dabrafenib plus trametinib adjuvant therapy, were included. The primary objectives were treatment discontinuation rate and time to discontinuation. The secondary objectives included safety and efficacy. From October 2020 to March 2021, 65 patients were included. Dabrafenib and trametinib discontinuation rate due to treatment-related adverse events (TRAEs) of any grade was 9%. Other reasons for discontinuation included patients' decisions (6%), physician decisions (6%), unrelated adverse events (3%), disease progression (5%), and others (5%). The median time to treatment discontinuation was 9 months [95% confidence interval (CI), 5-11]. G3-4 TRAEs occurred in 21.5% of patients, the most common being pyrexia (3%), asthenia (3%), and diarrhoea (3%). Unscheduled hospitalisations and clinical tests occurred in 6 and 22% of patients, respectively. After 20-month median follow-up (95% CI, 18-22), 9% of patients had exitus due to disease progression, with a 12-month relapse-free survival and overall survival rates of 95.3% and 100%, respectively. Dabrafenib and trametinib adjuvant therapy proved effective for melanoma patients in a real-world setting, with a manageable toxicity profile. Toxicity frequencies were low leading to low incidence of unscheduled medical visits, tests, and treatment discontinuations.Ovid Technologies (Wolters Kluwer Health)2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/205363Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1097/CMR.0000000000000888Melanoma Research, 2023, vol. 33, num. 5, p. 388-397https://doi.org/10.1097/CMR.0000000000000888cc by-nc-nd (c) Manzano, José L. et al., 2023http://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2053632026-05-27T06:46:51Z
dc.title.none.fl_str_mv Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
title Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
spellingShingle Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
Manzano, José L.
Tractament adjuvant del càncer
Melanoma
Adjuvant treatment of cancer
Melanoma
title_short Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
title_full Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
title_fullStr Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
title_full_unstemmed Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
title_sort Adjuvant dabrafenib and trametinib for patients with resected BRAF-mutated melanoma: DESCRIBE-AD real-world retrospective observational study
dc.creator.none.fl_str_mv Manzano, José L.
Martin Liberal, Juan
Fernández Morales, Luis A.
Benítez, Gretel
Medina Martínez, Javier
Quindós, María
García Castaño, Almudena
Fernández, Ovidio
Simo, Rocío V.
Majem, Margarita
Bellido, Lorena
Ayala de Miguel, Pablo
Campos Bonilla, Begoña
Espinosa, Enrique
Macías Cerrolaza, José A.
Gil Arnaiz, Irene
Lorente, David
Rodriguez Lescure, Alvaro
Perez, Victor N.
López Castro, Rafael
Gramaje, María G.
Puértolas, Teresa
Rodriguez Moreno, Juan F.
Espasa Font, Laia
Belaustegui Ferrández, Guillermo
Cerezuela Fuentes, Pablo
author Manzano, José L.
author_facet Manzano, José L.
Martin Liberal, Juan
Fernández Morales, Luis A.
Benítez, Gretel
Medina Martínez, Javier
Quindós, María
García Castaño, Almudena
Fernández, Ovidio
Simo, Rocío V.
Majem, Margarita
Bellido, Lorena
Ayala de Miguel, Pablo
Campos Bonilla, Begoña
Espinosa, Enrique
Macías Cerrolaza, José A.
Gil Arnaiz, Irene
Lorente, David
Rodriguez Lescure, Alvaro
Perez, Victor N.
López Castro, Rafael
Gramaje, María G.
Puértolas, Teresa
Rodriguez Moreno, Juan F.
Espasa Font, Laia
Belaustegui Ferrández, Guillermo
Cerezuela Fuentes, Pablo
author_role author
author2 Martin Liberal, Juan
Fernández Morales, Luis A.
Benítez, Gretel
Medina Martínez, Javier
Quindós, María
García Castaño, Almudena
Fernández, Ovidio
Simo, Rocío V.
Majem, Margarita
Bellido, Lorena
Ayala de Miguel, Pablo
Campos Bonilla, Begoña
Espinosa, Enrique
Macías Cerrolaza, José A.
Gil Arnaiz, Irene
Lorente, David
Rodriguez Lescure, Alvaro
Perez, Victor N.
López Castro, Rafael
Gramaje, María G.
Puértolas, Teresa
Rodriguez Moreno, Juan F.
Espasa Font, Laia
Belaustegui Ferrández, Guillermo
Cerezuela Fuentes, Pablo
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Tractament adjuvant del càncer
Melanoma
Adjuvant treatment of cancer
Melanoma
topic Tractament adjuvant del càncer
Melanoma
Adjuvant treatment of cancer
Melanoma
description BRAF and MEK inhibitor, dabrafenib plus trametinib, adjuvant therapy is effective for high-risk resected melanoma patients with BRAF-V600 mutations. However, real-world evidence is limited. We aimed to determine the feasibility of this therapy in routine clinical practice. DESCRIBE-AD, a retrospective observational study, collected real-world data from 25 hospitals in Spain. Histologically confirmed and resected BRAF-mutated melanoma patients aged & GE;18 years who were previously treated with dabrafenib plus trametinib adjuvant therapy, were included. The primary objectives were treatment discontinuation rate and time to discontinuation. The secondary objectives included safety and efficacy. From October 2020 to March 2021, 65 patients were included. Dabrafenib and trametinib discontinuation rate due to treatment-related adverse events (TRAEs) of any grade was 9%. Other reasons for discontinuation included patients' decisions (6%), physician decisions (6%), unrelated adverse events (3%), disease progression (5%), and others (5%). The median time to treatment discontinuation was 9 months [95% confidence interval (CI), 5-11]. G3-4 TRAEs occurred in 21.5% of patients, the most common being pyrexia (3%), asthenia (3%), and diarrhoea (3%). Unscheduled hospitalisations and clinical tests occurred in 6 and 22% of patients, respectively. After 20-month median follow-up (95% CI, 18-22), 9% of patients had exitus due to disease progression, with a 12-month relapse-free survival and overall survival rates of 95.3% and 100%, respectively. Dabrafenib and trametinib adjuvant therapy proved effective for melanoma patients in a real-world setting, with a manageable toxicity profile. Toxicity frequencies were low leading to low incidence of unscheduled medical visits, tests, and treatment discontinuations.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/205363
url https://hdl.handle.net/2445/205363
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1097/CMR.0000000000000888
Melanoma Research, 2023, vol. 33, num. 5, p. 388-397
https://doi.org/10.1097/CMR.0000000000000888
dc.rights.none.fl_str_mv cc by-nc-nd (c) Manzano, José L. et al., 2023
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by-nc-nd (c) Manzano, José L. et al., 2023
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Ovid Technologies (Wolters Kluwer Health)
publisher.none.fl_str_mv Ovid Technologies (Wolters Kluwer Health)
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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