Adjuvant dabrafenib and trametinib for patients with resected BRAF -mutated melanoma: DESCRIBE-AD real-world retrospective observational study
Por:
Manzano J.L., Martin-Liberal J., Fernández-Morales L.A., Benítez G., Medina Martínez J., Quindós M., García-Castaño A., Fernández O., Simo R.V., Majem M., Bellido L., Ayala de Miguel P., Campos B., Espinosa E., Macías Cerrolaza J.A., Gil-Arnaiz I., Lorente D., Rodriguez-Lescure A., Perez V.N., López Castro R., Gramaje M.G., Puértolas T., Rodriguez Moreno J.F., Espasa Font L., Belaustegui Ferrández G., Cerezuela-Fuentes P.
Publicada:
1 ene 2023
Ahead of Print:
28 mar 2023
Resumen:
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.
Filiaciones:
Manzano J.L.:
Medical Oncology, Instituto Catalán de Oncología, ICO-Badalona, H. Germans Trias i Pujol, Badalona, Spain
Martin-Liberal J.:
Medical Oncology, Catalan Institute of Oncology (ICO) L'Hospitalet
Fernández-Morales L.A.:
Medical Oncology, Parc Taulí Sabadell Hospital Universitari, Sabadell, Barcelona
Benítez G.:
Medical Oncology, Hospital Universitario Insular de Gran Canaria, Las Palmas, Mexico
Medina Martínez J.:
Medical Oncology, Hospital Universitario ToledoToledo, Belize
Quindós M.:
Medical Oncology, Complejo Hospitalario Universitario A Coruña
García-Castaño A.:
Medical Oncology, Hospital Universitario Marqués de ValdecillaSantander, Colombia
Fernández O.:
Medical Oncology, Complejo Hospitalario Universitario de Ourense
Simo R.V.:
Medical Oncology, Hospital Arquitecto Marcide, Ferrol, Philippines
Majem M.:
Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Philippines
Bellido L.:
Medical Oncology, Complejo Asistencial Universitario de Salamanca, Salamanca, Mexico
Ayala de Miguel P.:
Medical Oncology, Hospital San Pedro Alcántara, Cáceres
Campos B.:
Medical Oncology, Hospital Universitario Lucus Augusti de Lugo, Lugo, Italy
Espinosa E.:
Medical Oncology, Hospital Universitario La Paz - CIBERONCMadrid, Spain
Macías Cerrolaza J.A.:
Medical Oncology, Hospital General Universitario Morales MeseguerMurcia, Spain
Gil-Arnaiz I.:
Medical Oncology, Hospital Reina Sofía de Tudela, Navarra, Mexico
Lorente D.:
Medical Oncology, Hospital Provincial de Castellón, Castellón de la Plana
Rodriguez-Lescure A.:
Medical Oncology, Hospital General Universitario de Elche, Alicante, Philippines
Perez V.N.:
Medical Oncology, Hospital Costa del Sol, Málaga
López Castro R.:
Medical Oncology, Hospital Clínico Universitario de Valladolid, Valladolid, Mexico
Gramaje M.G.:
Medical Oncology, Hospital Universitario Son Llàtzer, Mallorca
Puértolas T.:
Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Mexico
Rodriguez Moreno J.F.:
Medical Oncology, Centro Integral Oncologico HM Clara CampalMadrid, Spain
Espasa Font L.:
Solid Tumours Medical Department, Novartis Farmacéutica S.A., Barcelona, Philippines
Belaustegui Ferrández G.:
Market Access Department, Novartis Farmacéutica S.A, Barcelona, Philippines
Cerezuela-Fuentes P.:
Medical Oncology, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Ciudad de Murcia, Spain
Green Published, hybrid, All Open Access; Hybrid Gold
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