Vicente Villanueva1, Rosana Saiz-Diaz2, Manuel Toledo3, Ana Piera4, Jose Angel Mauri5, Juan Jesús Rodriguez-Uranga6, Francisco Javier López-González7, Asier Gómez-Ibáñez8, Mercedes Garcés8, Jesús González de la Aleja2, Xiana Rodríguez-Osorio7, Susana Palao-Duarte9, Ascensión Castillo10, Macarena Bonet11, Jesús Ruiz-Giménez12, Juan Palau13, Alberto Arcediano14, Maria Toledo15, Ana Gago15. 1. Hospital Universitario y Politécnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026 Valencia, Spain. Electronic address: vevillanuevah@yahoo.es. 2. Hospital Universitario 12 de Octubre, Avda de Córdoba, s/n, 28041 Madrid, Spain. 3. Hospital Universitario Vall d'Hebron, Passeig de la Vall d'Hebron, 119-129, 08035 Barcelona, Spain. 4. Hospital Clínico Universitario Valencia, Spain. 5. Hospital Clínico Universitario Lozano Blesa, Calle de San Juan Bosco, 15, 50009 Zaragoza, Spain. 6. Instituto de Especialidades Neurológicas, Hospital Quirón, Av Manuel Siurot, 57, 41013 Sevilla, Spain. 7. Hospital Clínico Universitario Santiago, Spain. 8. Hospital Universitario y Politécnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026 Valencia, Spain. 9. Hospital General Universitario Alicante, Spain. 10. Consorcio Hospital General Universitario de Valencia, Av Tres Cruces, 2, 46014, Valencia, Spain. 11. Hospital Arnau de Vilanova, Calle San Clemente, 12, 46015, Valencia, Spain. 12. Hospital Universitario Virgen de las Nieves, Avenida de las Fuerzas Armadas, 2, 18014 Granada, Spain. 13. Hospital Manises Avenidad Generalitat Valenciana, 46940 Manises, Spain. 14. Hospital Universitario Guadalajara, Guadalajara, Spain. 15. Hospital Universitario La Princesa Madrid, Calle Diego de León, Madrid, Spain.
Abstract
BACKGROUND: The choice of antiepileptic drug (AED) therapy in patients with brain tumor-related epilepsy (BTRE) is complicated, and there are a lack of robust clinical trial data to date. METHODS: The NEOPLASM (Neuroncologic Patients treated with LAcoSaMide) study was a 6-month, multicenter, retrospective, observational study in patients with BTRE treated with lacosamide. Patients were started on lacosamide because of a lack of efficacy or adverse events (AEs) with prior AEDs or suitability versus other AEDs, according to clinical practice. The primary efficacy variable was the seizure-free rate at 6months. Safety variables included the proportion of patients with an AE and the proportion with an AE that led to discontinuation. RESULTS: Overall, 105 patients from 14 hospital centers were included in the analysis. Treatment with lacosamide for 6months resulted in a 30.8% seizure-free rate, and 66.3% of patients had a ≥50% seizure reduction (responders). In the subset of patients included because of a lack of efficacy with prior AEDs, seizure-free rates were 28.0%, and 66.7% of patients were responders. No statistically significant differences in efficacy were observed according to the mechanism of action or enzyme-inducing properties of concomitant AEDs. Adverse events were reported by 41.9% of patients at 6months, and 4.7% of them led to discontinuation. The most common AEs were somnolence/fatigue and dizziness. Notably, 57.1% of the patients who were switched to lacosamide because of AEs with their previous therapy did not report any AE at 6-month follow-up. CONCLUSIONS: In this open-label, observational study, lacosamide appeared to be effective and well tolerated in a large population of patients with BTRE. Lacosamide may therefore be a promising option for the treatment of patients with BTRE.
BACKGROUND: The choice of antiepileptic drug (AED) therapy in patients with brain tumor-related epilepsy (BTRE) is complicated, and there are a lack of robust clinical trial data to date. METHODS: The NEOPLASM (Neuroncologic Patients treated with LAcoSaMide) study was a 6-month, multicenter, retrospective, observational study in patients with BTRE treated with lacosamide. Patients were started on lacosamide because of a lack of efficacy or adverse events (AEs) with prior AEDs or suitability versus other AEDs, according to clinical practice. The primary efficacy variable was the seizure-free rate at 6months. Safety variables included the proportion of patients with an AE and the proportion with an AE that led to discontinuation. RESULTS: Overall, 105 patients from 14 hospital centers were included in the analysis. Treatment with lacosamide for 6months resulted in a 30.8% seizure-free rate, and 66.3% of patients had a ≥50% seizure reduction (responders). In the subset of patients included because of a lack of efficacy with prior AEDs, seizure-free rates were 28.0%, and 66.7% of patients were responders. No statistically significant differences in efficacy were observed according to the mechanism of action or enzyme-inducing properties of concomitant AEDs. Adverse events were reported by 41.9% of patients at 6months, and 4.7% of them led to discontinuation. The most common AEs were somnolence/fatigue and dizziness. Notably, 57.1% of the patients who were switched to lacosamide because of AEs with their previous therapy did not report any AE at 6-month follow-up. CONCLUSIONS: In this open-label, observational study, lacosamide appeared to be effective and well tolerated in a large population of patients with BTRE. Lacosamide may therefore be a promising option for the treatment of patients with BTRE.
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