Abstract
Optune® is an FDA-approved portable medical device that delivers continuous treatment with Tumor-Treating Fields (TTFields) to the supratentorial region of the brain and is indicated for the treatment of newly diagnosed glioblastoma multiforme (GBM) in combination with temozolomide and for recurrent GBM as a monotherapy. TTFields are alternating electric fields that disrupt charged proteins involved in cell division thereby serving as an anti-mitotic therapy. The delivery of TTFields to the brain is achieved with externally applied transducer arrays that are attached to the shaved scalp and powered by the TTFields generator. There is no half-life associated with TTFields, meaning that once the device is powered off, therapy immediately halts. The device maintains an internal log reflecting the time on and off and thereby provides an objective measure of daily duration of therapy – termed compliance. Subset analyses from two phase 3 pivotal trials; EF-14 and EF-11, as well as a commercial patient registry dataset (PRiDe) have consistently demonstrated that patient compliance on Optune of ≥75%, which equates to a monthly average of ≥18 hours per day, correlates with a statistically significant increase in overall survival compared to patients with ˂75% compliance. The duration of therapy, i.e. the number of months of active treatment, also positively correlates with survival and tumor response. Due to the survival benefit conferred by compliance and duration of therapy, strategies that increase the safe use and integration of Optune into the activities of daily living of GBM patients, will maximize the chance for patients to respond to therapy and should be part of the medical oversight of Optune-treated patients. Optune is an innovative regional therapy and standard treatment option for GBM whose efficacy relies on informed healthcare practitioners and effective patient self-management to remain compliant while managing practical issues and skin irritation associated with this therapy.