José L Manzano, Juan Martin-Liberal, Luis A Fernández-Morales, Gretel Benítez, Javier Medina Martínez, María Quindós, Almudena García-Castaño, Ovidio Fernández, Rocío V Simo, Margarita Majem, Lorena Bellido, Pablo Ayala de Miguel, Begoña Campos, Enrique Espinosa, José A Macías Cerrolaza, Irene Gil-Arnaiz, David Lorente, Alvaro Rodriguez-Lescure, Victor N Perez, Rafael López Castro, María G Gramaje, Teresa Puértolas, Juan F Rodriguez Moreno, Laia Espasa Font, Guillermo Belaustegui Ferrández, Pablo Cerezuela-Fuentes
{"title":"达非尼和曲美替尼佐剂治疗BRAF突变黑色素瘤切除患者:DESCRIBE-AD真实世界回顾性观察研究。","authors":"José L Manzano, Juan Martin-Liberal, Luis A Fernández-Morales, Gretel Benítez, Javier Medina Martínez, María Quindós, Almudena García-Castaño, Ovidio Fernández, Rocío V Simo, Margarita Majem, Lorena Bellido, Pablo Ayala de Miguel, Begoña Campos, Enrique Espinosa, José A Macías Cerrolaza, Irene Gil-Arnaiz, David Lorente, Alvaro Rodriguez-Lescure, Victor N Perez, Rafael López Castro, María G Gramaje, Teresa Puértolas, Juan F Rodriguez Moreno, Laia Espasa Font, Guillermo Belaustegui Ferrández, Pablo Cerezuela-Fuentes","doi":"10.1097/CMR.0000000000000888","DOIUrl":null,"url":null,"abstract":"<p><p>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 ≥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.</p>","PeriodicalId":18550,"journal":{"name":"Melanoma Research","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3f/11/mr-33-388.PMC10470432.pdf","citationCount":"0","resultStr":"{\"title\":\"Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study.\",\"authors\":\"José L Manzano, Juan Martin-Liberal, Luis A Fernández-Morales, Gretel Benítez, Javier Medina Martínez, María Quindós, Almudena García-Castaño, Ovidio Fernández, Rocío V Simo, Margarita Majem, Lorena Bellido, Pablo Ayala de Miguel, Begoña Campos, Enrique Espinosa, José A Macías Cerrolaza, Irene Gil-Arnaiz, David Lorente, Alvaro Rodriguez-Lescure, Victor N Perez, Rafael López Castro, María G Gramaje, Teresa Puértolas, Juan F Rodriguez Moreno, Laia Espasa Font, Guillermo Belaustegui Ferrández, Pablo Cerezuela-Fuentes\",\"doi\":\"10.1097/CMR.0000000000000888\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>BRAF and MEK inhibitor, dabrafenib plus trametinib, adjuvant therapy is effective for high-risk resected melanoma patients with BRAF - V600 mutations. 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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. 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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 retrospective observational study, collected real-world data from 25 hospitals in Spain. Histologically confirmed and resected BRAF -mutated melanoma patients aged ≥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.
期刊介绍:
Melanoma Research is a well established international forum for the dissemination of new findings relating to melanoma. The aim of the Journal is to promote the level of informational exchange between those engaged in the field. Melanoma Research aims to encourage an informed and balanced view of experimental and clinical research and extend and stimulate communication and exchange of knowledge between investigators with differing areas of expertise. This will foster the development of translational research. The reporting of new clinical results and the effect and toxicity of new therapeutic agents and immunotherapy will be given emphasis by rapid publication of Short Communications. Thus, Melanoma Research seeks to present a coherent and up-to-date account of all aspects of investigations pertinent to melanoma. Consequently the scope of the Journal is broad, embracing the entire range of studies from fundamental and applied research in such subject areas as genetics, molecular biology, biochemistry, cell biology, photobiology, pathology, immunology, and advances in clinical oncology influencing the prevention, diagnosis and treatment of melanoma.