title: Oxcarbazepine monotherapy in patients with brain tumor-related epilepsy: open-label pilot study for assessing the efficacy, tolerability and impact on quality of life.
abstract: We conducted a prospective, observational study to verify the efficacy, tolerability and impact on quality of life, mood and global neurocognitive performances of oxcarbazepine monotherapy in patients with brain tumor-related epilepsy (BTRE). Patients were followed for 12 months. We recruited 25 patients (11 females 14 males; mean age 49.7) affected with BTRE (17 de novo patients and 7 in monotherapy with other antiepileptics) and introduced oxcarbazepine monotherapy because of uncontrolled seizures and/or side effects. At first visit, patients underwent neurological examination, Qolie 31P V2, EORTC QLQC30, Zung self-depression rating scale (ZSDRS) and adverse events profile. A seizure diary was given to each patient. Follow-up duration was 1-12 months (mean 7.1 months, 5 patients died and 10 dropped out). Totals of 16 patients underwent both chemotherapy and radiotherapy, 4 chemotherapy only, 1 radiotherapy only, and 4 did not undergo any systemic therapy. Mean dosage of oxcarbazepine was 1,230 mg/day (min 600, max 2,100 mg/day). McNemar's test showed a significant difference in seizure freedom rate (P = 0.002) between baseline and final follow-up in the intent-to-treat population. Six patients (24%) had serious side effects and one patient (4%) mild. Logistic regression revealed that, in our study, chemotherapy and radiotherapy did not affect the efficacy of OXC in seizure outcome (P = 0.658). The test evaluation at final follow-up showed a significant improvement in ZSDRS (P = 0.011) and no change over time. Oxcarbazepine seems to be efficacious in controlling seizures and in improving mood in patients with BTRE, but special caution should be taken when it is administered during radiotherapy.
authors.affiliation: Department of Neuroscience and Cervical-Facial Pathology, Center for Tumor-related Epilepsy, National Institute for Cancer, Regina Elena, Via Elio Chianesi 53, 00144, Rome, Italy. maschio@ifo.it
authors.forename: M
authors.initials: M
authors.lastname: Maschio
authors.forename: L
authors.initials: L
authors.lastname: Dinapoli
authors.forename: F
authors.initials: F
authors.lastname: Sperati
authors.forename: A
authors.initials: A
authors.lastname: Fabi
authors.forename: A
authors.initials: A
authors.lastname: Pace
authors.forename: A
authors.initials: A
authors.lastname: Vidiri
authors.forename: P
authors.initials: P
authors.lastname: Muti
mesh_terms: D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000150:complications; D002220:Carbamazepine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004827:Epilepsy / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology*; D005260:Female; D005910:Glioma / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D009483:Neuropsychological Tests; D000078330:Oxcarbazepine; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine