THE DEVICE — Optune Pax consists of an electric field generator (the device) and insulated transducer arrays (adhesive patches). The device delivers tumor treating fields (150 kHz) to the abdominal cavity through non-invasive, electrically-insulated transducer arrays for at least 12 hours daily. The tumor treating fields disrupt cancer cell proliferation and induce apoptosis. Unlike chemotherapy, tumor treating fields do not effect non-dividing cells or rapidly proliferating cells in other areas of the body, which minimizes adverse effects.

CLINICAL STUDIES — FDA approval of the device was based on the results of an open-label trial (PANOVA-3) in 571 patients with newly-diagnosed locally advanced pancreatic cancer who were randomized to receive GnP with tumor treating fields or GnP alone. Median overall survival was statistically significantly longer in patients in the tumor treating fields arm compared to the standard treatment arm (16.2 months vs 14.2 months). Pain-free survival was also significantly longer (15.2 months vs 9.1 months with GnP alone). The device did not prolong progression-free survival or improve overall response rates.1

ADVERSE EFFECTS — Skin irritation under the transducer arrays occurred in ≥75% of patients in the clinical trial. Other adverse effects included abdominal pain, diarrhea, anemia, and infection.

CONCLUSION — The portable Optune Pax device plus standard chemotherapy extended median overall survival by 2 months compared to standard chemotherapy alone in patients with locally advanced pancreatic cancer.