Safety and Feasibility of Pulsed Electric Field Ablation for Early-Stage Non-Small Cell Lung Cancer Prior to Surgical Resection.

Abstract

Background and methods: Surgery remains the standard of care for non-small cell lung cancer (NSCLC) but is applicable to ≤ 30% of patients. Pulsed Electric Fields (PEF) ablation uses short-duration, high-voltage electrical pulses to induce cell death without relying on thermal mechanisms. Safety findings are reported from a two-arm, non-randomized, study evaluating the use of PEF in patients with early-stage NSCLC.

Methods: PEF energy was delivered bronchoscopically or percutaneously to 36 patients with suspected or confirmed early-stage NSCLC approximately 20 days before resection; 8 control patients had biopsy only. The primary safety analysis was the device and/or procedure related serious adverse events (AEs) rate from PEF procedure through resection. Immunohistochemical evaluation of resected tissue was also assessed.

Results: PEF was delivered to all patients in the treatment group after biopsy of targeted tumor. No device or procedure-related AE were observed. Histopathological assessment of resected tumors demonstrated a cellular depletion zone characterized by decrease or absence of tumor cellularity and a variable degree of inflammation. Tertiary lymphoid structures were observed within PEF-treated tumors.

Conclusions: These clinical observations and histopathologic tissue alterations, indicate that PEF energy delivery is feasible and safe in NSCLC, with potential signals of immune system activation.