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Dabrafenib plus trametinib for compassionate use in metastatic melanoma: A STROBE-compliant retrospective

Salvador Martín Algarra¹, Virtudes Soriano, Luis Fernández-Morales

¹Medical Oncology, Clínica Universidad de Navarra, Pamplona Instituto Valenciano de Oncología, Valencia Medical Oncology, Parc Taulí Sabadell Hospital Universitario, Sabadell Oncología Intercentros, Hospitales Universitarios Regional y Virgen de la Victoria (HURyVV) and Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga Onkologikoa, Instituto Oncológico de Kutxa, San Sebastian Instituto Catalán de Oncología, ICO-Badalona, Hospital Germans Trías I Pujol, Barcelona Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid Medical Oncology, Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria, Las Palmas de Gran Canaria Medical Oncology, Hospital Universitario La Paz, Madrid Medical Oncology, Hospital Virgen de la Salud, Toledo Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid Instituto Catalán de Oncología Girona, Girona Medical Oncology, Hospital Universitario Arnau de Vilanova, Lleida Medical Oncology, Hospital Universitario San Cecilio, Granada Medical Oncology, Complejo Hospitalario de Navarra, Pamplona Medical Oncology, Hospital Universitario Central de Asturias, Oviedo Medical Oncology, Hospital Universitario Nuestra Señora de Valme, Sevilla Medical Oncology, Hospital General Universitario de Elche, Alicante Medical Oncology, Complejo Hospitalario Torrecárdenas de Almería, Almería Medical Oncology, Hospital Marqués de Valdecilla, Santander Medical Oncology, Hospital Universitario Son Espases, Palma de Mallorca Medical Oncology, Hospital Universitario La Princesa, Madrid Medical Oncology, Complejo Hospitalario Universitario Ourense, Ourense Medical Oncology, Hospital Universitario 12 de Octubre, Madrid Medical Oncology, Hospital General Universitario de Valencia, Valencia Medical Oncology, Hospital Clínic Barcelona, Barcelona, Spain.

|February 1, 2018

Abstract:

The main objective of the study was to evaluate the efficacy and safety of dabrafenib alone or combined with trametinib for compassionate use in patients with metastatic melanoma.This retrospective, observational study involved 135 patients with unresectable stage IIIC or stage IV melanoma from an expanded-access program at 30 Spanish centers.Forty-eight patients received dabrafenib monotherapy and 87 received combination dabrafenib and trametinib; 4.4% and 95.6% of the patients had stage IIIC and IV melanoma, respectively. All patients showed BRAF mutations in their primary or metastatic lesions; 3 were positive for V600K while the remainder had V600E or V600+. A positive response to treatment was reported in 89.3% of the patients. Overall survival rates at 12 and 24 months were 59.6% (95% confidence interval [CI], 52.5-68.9%) and 36.4% (95% CI, 27.8-45%), respectively. Progression-free survival rates at 12 and 24 months were 39.3% (95% CI, 31.1-47.5%) and 21.6% (95% CI, 14.5-28.7%), respectively. Fifty-seven patients (42.2%) reported cutaneous toxicity of any type, mainly hyperkeratosis (14.8%) and rash (11.9%). The most frequent adverse events were pyrexia (27.4%), asthenia (19.3%), arthralgia (16.9%), and diarrhoea (13.2%).Our results suggest that both dabrafenib alone or in combination with trametinib are effective for compassionate use in terms of response and/or survival rates. However, differences in patients' prognostic features ought to be considered. No new findings were revealed regarding the safety profiles of either regimen. This is the first study to evaluate the efficacy of these 2 selective BRAF and mitogen-activated extracellular signal-regulated kinase inhibitors in a real-world setting in Spain.

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