P16.03 Efficacy and tolerability of lacosamide in patients with glioma: final results of a mono-institutional prospective study

Abstract

AbstractBackground:Lacosamide (LCM) has been suggested in few retrospective studies to improve seizure control as an add-on treatment in brain tumor patients. We present the final results of a prospective study on a cohort of patients with low grade (LGG) and high grade gliomas (HGG) and medically intractable epilepsy who received LCM.Patients and methods:Eligibility criteria were as follows: 1) biopsy-proven grade II or III or IV gliomas according to WHO 2007; 2) persisting seizures (seizure frequency > 1 per month) despite a treatment with 1 or more antiepileptic drugs (AEDs) for at least 3 months and adequate serum concentration; 3) stable steroid dose; 4) available information on tumor response on MRI according to RANO criteria following chemotherapy or radiotherapy; 5) age > 18 years. LCM was given at 50 mg daily for one week with an increase of 50 mg twice daily every week to a target dose of 200–400 mg/day. The endpoints were > 50% decrease of seizure frequency and seizure freedom at 6 and 9 months.Results:Since January 2012 71 patients were evaluable. There were 26 grade II gliomas, 20 grade III and 25 glioblastomas. Eleven patients (15.5%) had generalized seizures and 32 (95.7%) partial seizures. Forty-four patients (61.8%) were or on AED monotherapy while 27 (38.2%) on polytherapy. Reasons for introduction of LCM were lack of efficacy of previous AEDs associated with (46.5%) or without (53.5%) progressive disease on MRI or unacceptable side effects of traditional AEDs in 11 patients (15.5%). Median duration of follow up was 9 months (range 3–24 months).Among LGG at 6 months from start of LCM 11/26 patients (42.3%) had a reduction of >50% of seizure frequency while seizure freedom was obtained in 11/26 (42.3%); at 9 months a reduction of >50% of seizure frequency was observed in 9/24 (37.5%) while seizure freedom was obtained in other 13 (54.2%). Moreover, 11/26 patients (42.3%) at 6 months and 10/26 (38.5%) at 9 months were seizure responders respectively, without concurrent antineoplastic therapies. As for HGG at 6 months 10/39 patients (25.6%) had a reduction of >50% of seizure frequency while seizure freedom was obtained in 18/39 (46.1%); at 9 months a reduction of >50% of seizure frequency was observed in 7/32 (21.8%) and seizure freedom in other 17 (53.1%). A resolution of an epileptic status was obtained in 6 patients of whom one receiving LCM alone. Secondary generalized seizures disappeared in 14 patients. Two responding patients were able to reduce the doses of previous AEDs. Most patients (87.3%) did not report significant toxicities: in 2 cases only LCM was withdrawn due to dizziness and fatigue and resistant epilepsy, respectively.Conclusion:At our knowledge this is the first prospective study on patients with both LGG and HGG with LCM as an add-on treatment showing a significant activity, even regardless of tumor response to antineoplastic treatment. LCM did not have interactions with AEDs.