Abstracts

Rationale: Seizure is the most common symptom of brain tumors. Brain tumor-related epilepsy (BTRE) and treatment with anti-epileptic drugs (AEDs) are significant causes of morbidity in this population as they negatively affect quality of life and contribute to cognitive impairment. The aim of this study is to examine the safety and efficacy of pharmaceutical grade Cannabidiol (CBD; Epidiolex, GW Pharmaceuticals) in patients with BTRE enrolled in the Alabama CBD Program. Methods: Of the 82 patients with refractory epilepsy enrolled in the program, 3 had history of a primary brain tumor. Two patients were enrolled at the University of Alabama at Birmingham and 1 at the Children's of Alabama since 4/1/15. Demographic information was collected for each patient. Seizure severity was assessed using the Chalfont Seizure Severity Scale (CSSS), seizure frequency using self-reported data, and adverse event data were collected for each patient. Results: Of the 3 patients examined, all were white males ages from 16-38 years. The average age of seizure onset was 5.4 years. Patient A had a history of a left temporal anaplastic astrocytoma (World Health Organization (WHO) Grade III) treated with surgical resection, radiation, and chemotherapy, Patient B had a history of a left temporal oligodendroglioma (WHO Grade II) treated with surgical resection, and Patient C had a history of a right temporal ganglioglioma (WHO Grade I) treated with surgical resection. All 3 patients had complex partial seizures (CPS) with and without secondary generalization (SG). The average number of AEDs at time of enrollment was 3.7 and the average number of previously failed AEDs was 8. Seizure frequency per month at time of enrollment as compared to mean seizure frequency over each patient's last 3 visits was as follows: 4 CPS without SG vs 1.7 CPS without SG for patient A (58% decrease), 0 CPS without SG and 3 CPS with SG vs 1.5 CPS without SG and 0.5 seizures with SG for patient B (overall decrease of 33%), and 9 CPS without SG and 2 CPS with SG vs 12 CPS without SG and 1.3 CPS with SG for patient C (overall 21% increase). CSSS at time of enrollment was 24, 118, and 118 and CSSS averaged over the last 3 visits was 8, 9, and 98 for patients A, B, and C, respectively reflecting an improvement in all patients including the last patient who had worsening in seizure frequency. Profile of Mood States (POMS) data were available for adult patients only (patients A and B) and Total Mood Disturbance Scores were 16 and 36 at time of enrollment and 9 and 10 at last visit for patients A and B, respectively (lower score better). Currently, Patient A remains on treatment, Patient B is deceased secondary to Sudden Unexplained Death in Epilepsy, and Patient C withdrew from the study secondary to diarrhea. No other side effects were reported in these patients. Conclusions: These data suggest that CBD may be safe and effective in some patients with BTRE and point to the need for further investigation of CBD oil as a treatment option in this unique population of refractory epilepsy patients. Funding: State of Alabama