Abstract

Tumor Treating Fields (TTFields) are a noninvasive, antineoplastic treatment delivered locoregionally to tumor bed via low intensity (1-3 V/cm), intermediate frequency (100-500 kHz), alternating electric fields. This treatment modality has been shown to be cytotoxic to rapidly dividing cells, with highest efficacy demonstrated at different optimal frequencies depending on tumor cell-type. TTFields therapy has extended survival of patients with newly diagnosed glioblastoma (GBM) and is FDA approved for the treatment of newly diagnosed and recurrent GBM. The overall tolerable safety profile of TTFields in patients (EF-11 and EF-14 clinical trials) is attributed to the low rate of mitotic events in normal, quiescent brain cells. Further evaluation of the safety profile is needed to treat various solid tumor cancer types at the torso region in which there are high rates of cellular proliferation. Hence, we investigated the safety of TTFields delivery to the torso of rats at conditions deemed effective for treating the aforementioned cancer cell types. TTFields were applied to torsos of Sprague Dawley (SD) female rats for 2 weeks using the Novo-TTF100L system at frequencies of 150 or 200 kHz and intensities of 1-2 V/cm RMS. Throughout the treatment period, animals underwent daily clinical examinations. At treatment cessation, blood samples were analyzed and comparative histological evaluation of major internal organs was performed. Animals from the TTFields treatment groups showed no significant differences in comparison to control groups for the following parameters: activity level, food and water intake, stools, motor neurological status, respiration, weight, complete blood count, blood biochemistry, and pathological findings. Safety of TTFields at frequencies of 150 and 200 kHz was demonstrated in healthy rats when delivered to the torso, where there are normal tissues that exhibit high rates of cellular proliferation. Results further suggest that TTFields is a feasibly safe and tolerable treatment modality for treating thoracic as well as other abdominal and pelvic cancers within the torso. Clinical studies investigating TTFields for the treatment of solid malignant tumors located in the torso are currently underway, including locally advanced pancreatic cancer (PANOVA-3 Study, NCT03377491), ovarian cancer (INNOVATE-3 Study, NCT03940196), lung cancer (LUNAR Study, NCT02973789), hepatocellular carcinoma (HEPANOVA Study, NCT03606590), and gastric cancer.

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