PMID- 27863278 OWN - NLM STAT- MEDLINE DCOM- 20170816 LR - 20181202 IS - 1525-5069 (Electronic) IS - 1525-5050 (Linking) VI - 65 DP - 2016 Dec TI - NEOPLASM study: Real-life use of lacosamide in patients with brain tumor-related epilepsy. PG - 25-32 LID - S1525-5050(16)30158-5 [pii] LID - 10.1016/j.yebeh.2016.09.033 [doi] AB - 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. CI - Copyright (c) 2016 Elsevier Inc. All rights reserved. FAU - Villanueva, Vicente AU - Villanueva V AD - Hospital Universitario y Politecnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026 Valencia, Spain. Electronic address: vevillanuevah@yahoo.es. FAU - Saiz-Diaz, Rosana AU - Saiz-Diaz R AD - Hospital Universitario 12 de Octubre, Avda de Cordoba, s/n, 28041 Madrid, Spain. FAU - Toledo, Manuel AU - Toledo M AD - Hospital Universitario Vall d'Hebron, Passeig de la Vall d'Hebron, 119-129, 08035 Barcelona, Spain. FAU - Piera, Ana AU - Piera A AD - Hospital Clinico Universitario Valencia, Spain. FAU - Mauri, Jose Angel AU - Mauri JA AD - Hospital Clinico Universitario Lozano Blesa, Calle de San Juan Bosco, 15, 50009 Zaragoza, Spain. FAU - Rodriguez-Uranga, Juan Jesus AU - Rodriguez-Uranga JJ AD - Instituto de Especialidades Neurologicas, Hospital Quiron, Av Manuel Siurot, 57, 41013 Sevilla, Spain. FAU - Lopez-Gonzalez, Francisco Javier AU - Lopez-Gonzalez FJ AD - Hospital Clinico Universitario Santiago, Spain. FAU - Gomez-Ibanez, Asier AU - Gomez-Ibanez A AD - Hospital Universitario y Politecnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026 Valencia, Spain. FAU - Garces, Mercedes AU - Garces M AD - Hospital Universitario y Politecnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026 Valencia, Spain. FAU - Gonzalez de la Aleja, Jesus AU - Gonzalez de la Aleja J AD - Hospital Universitario 12 de Octubre, Avda de Cordoba, s/n, 28041 Madrid, Spain. FAU - Rodriguez-Osorio, Xiana AU - Rodriguez-Osorio X AD - Hospital Clinico Universitario Santiago, Spain. FAU - Palao-Duarte, Susana AU - Palao-Duarte S AD - Hospital General Universitario Alicante, Spain. FAU - Castillo, Ascension AU - Castillo A AD - Consorcio Hospital General Universitario de Valencia, Av Tres Cruces, 2, 46014, Valencia, Spain. FAU - Bonet, Macarena AU - Bonet M AD - Hospital Arnau de Vilanova, Calle San Clemente, 12, 46015, Valencia, Spain. FAU - Ruiz-Gimenez, Jesus AU - Ruiz-Gimenez J AD - Hospital Universitario Virgen de las Nieves, Avenida de las Fuerzas Armadas, 2, 18014 Granada, Spain. FAU - Palau, Juan AU - Palau J AD - Hospital Manises Avenidad Generalitat Valenciana, 46940 Manises, Spain. FAU - Arcediano, Alberto AU - Arcediano A AD - Hospital Universitario Guadalajara, Guadalajara, Spain. FAU - Toledo, Maria AU - Toledo M AD - Hospital Universitario La Princesa Madrid, Calle Diego de Leon, Madrid, Spain. FAU - Gago, Ana AU - Gago A AD - Hospital Universitario La Princesa Madrid, Calle Diego de Leon, Madrid, Spain. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20161116 PL - United States TA - Epilepsy Behav JT - Epilepsy & behavior : E&B JID - 100892858 RN - 0 (Acetamides) RN - 0 (Anticonvulsants) RN - 563KS2PQY5 (Lacosamide) SB - IM MH - Acetamides/*therapeutic use MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anticonvulsants/*therapeutic use MH - Brain Neoplasms/*complications/diagnosis/*drug therapy MH - Epilepsy/diagnosis/*drug therapy/*etiology MH - Female MH - Follow-Up Studies MH - Humans MH - Lacosamide MH - Male MH - Middle Aged MH - Retrospective Studies MH - Seizures/diagnosis/drug therapy/epidemiology MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Antiepileptic drugs OT - Brain tumor OT - Epilepsy OT - Lacosamide EDAT- 2016/11/20 06:00 MHDA- 2017/08/17 06:00 CRDT- 2016/11/19 06:00 PHST- 2016/06/14 00:00 [received] PHST- 2016/09/02 00:00 [revised] PHST- 2016/09/19 00:00 [accepted] PHST- 2016/11/20 06:00 [pubmed] PHST- 2017/08/17 06:00 [medline] PHST- 2016/11/19 06:00 [entrez] AID - S1525-5050(16)30158-5 [pii] AID - 10.1016/j.yebeh.2016.09.033 [doi] PST - ppublish SO - Epilepsy Behav. 2016 Dec;65:25-32. doi: 10.1016/j.yebeh.2016.09.033. Epub 2016 Nov 16.