ACTR-15. THERAPEUTIC KETOGENIC DIET (KD) WITH RADIATION AND CHEMOTHERAPY FOR NEWLY DIAGNOSED GLIOBLASTOMA – PRELIMINARY RESULTS FROM NCT02046187

Abstract

INTRODUCTION: The KD shows promise as a treatment for glio-blastoma (GB). Pre-clinical studies show potentitation of radiation and chemotherapy, enhanced anti-tumor immune-reactivity and a reduction in peri-tumoral edema, angiogenesis and hypoxia. It appears safe and tolerable, based on its use in the treatment of epilepsy and increasingly, by athletes/body-builders. METHODS: This was a single-institution trial. Under supervision of a Registered Dietician Nutritionist (RDN), patients followed a classic 4/1 (energy ratio, fat/ protein + carbohydrates) KD during radiation (RT, 6 weeks) and temozolomide (TMZ). Ketosis was verified by measurements of ketones and glucose. Thereafter, they were encouraged to follow a modified Atkins diet (1/1). We also include results from a number of patients who underwent identical treatment, but were not enrolled on the trial. RESULTS: 30 patients were approached and 14 patients enrolled on the trial; 2 stopped treatment prior to completion of RT due to tolerability. No weight loss of >10% base-line occurred. Nausea was reported by 4/14. There were no other significant adverse events. On an intention-to-treat basis, median time-to-progression (TTP) was 7 months and overall survival (OS) 29.3 months. In the 20 patients in total using the regimen, TTP and OS were 6.6 and 22 months. Additional analyses including comparisons with matched historic controls and molecular prognostic factors are in progress. CONCLUSION. The therapeutic KD appears safe. It is generally tolerable for the duration of radiotherapy. It is not practical for every patient and longer-term use is likely to be challenging. Close support from clinical personnel, particularly the RDN, is crucial. Preliminary results are encouraging. A trial of the KD in recurrent GB is planned.