NEOPLASM study: Real-life use of lacosamide in patients with brain tumor-related epilepsy

Epilepsy Behav. 2016 Dec:65:25-32. doi: 10.1016/j.yebeh.2016.09.033. Epub 2016 Nov 16.

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.

Keywords: Antiepileptic drugs; Brain tumor; Epilepsy; Lacosamide.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Acetamides / therapeutic use*
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticonvulsants / therapeutic use*
  • Brain Neoplasms / complications*
  • Brain Neoplasms / diagnosis
  • Brain Neoplasms / drug therapy*
  • Epilepsy / diagnosis
  • Epilepsy / drug therapy*
  • Epilepsy / etiology*
  • Female
  • Follow-Up Studies
  • Humans
  • Lacosamide
  • Male
  • Middle Aged
  • Retrospective Studies
  • Seizures / diagnosis
  • Seizures / drug therapy
  • Seizures / epidemiology
  • Treatment Outcome
  • Young Adult

Substances

  • Acetamides
  • Anticonvulsants
  • Lacosamide