Safety and Feasibility of Pulsed Electric Field Ablation for Early‐Stage Non‐Small Cell Lung Cancer Prior to Surgical Resection
Marcelo F. Jiménez, Javier Flandes, Erik H.F.M. van der Heijden, Calvin S.H. Ng, Jeffrey Iding, José Fernández García-Hierro, Borja Recalde‐Zamacona, Roel L.J. Verhoeven, Rainbow W. H. Lau, Alicia Moreno‐Gonzalez, Beryl A. Hatton, Partha Seshaiah, Maria B. Plentl, William Krimsky
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.