Abstract
BACKGROUND: Tumor Treating Fields (TTFields) are a non-invasive, anti-mitotic treatment modality, based on low intensity alternating electric fields. During mitosis, TTFields interfere with the formation of the mitotic spindle and physically translocate polarizable organelles. TTFields inhibit proliferation of non-small cell lung cancer (NSCLC) in vitro and in vivo, and have been demonstrated to prolonged survival when combined with maintenance temozolomide in GBM. METHODS: The COMET trial (NCT01755624) will enroll 60 patients with 1-5 NSCLC brain metastases who initially received definitive local treatment to all metastases. Patients are randomized (1:1) to either 150kHz TTFields applied to the entire brain or supportive care alone arms. Patients are followed-up monthly (brain MRI every 3 months). The trial is designed to study the safety, tolerability and efficacy of TTFields in this patient population. Median time to local and distant progression in the brain is the primary endpoint. Eligibility criteria include stable systemic disease and optimal systemic therapy for NSCLC. RESULTS: Seventeen patients have been enrolled in the trial to date (6 in the TTFields and 11 in the control arm of the study). The average follow-up time was 3.4 months. To date, 8 adverse events (AEs) have been reported in the TTFields arm and 18 in the control arm. Most adverse events were related to the underlying lung cancer. A single event (mild dermatitis) was related to TTFields. Two patients had a total of 4 Serious AEs (SAEs), 1 in the BSC and 1 in the TTFields arm (lower limb infection, pulmonary embolism, dyspnea and extra-cranial tumor progression). No SAE was related to TTFields. CONCLUSIONS: To date, TTFields demonstrate a high safety profile in patients suffering from brain metastases from NSCLC. The study continues to collect safety, neurocognitive and efficacy data.
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