Percutaneous radiofrequency ablation of stage IA non-small cell lung cancer: A prospective multicenter clinical trial

Abstract

7175 Background: This study is designed to determine feasibility, safety, and effectiveness of percutaneous computed tomography (CT)-guided radiofrequency ablation (RFA) of stage IA non-small cell lung cancer (NSCLC). Methods: Fourteen patients (12 males and 2 females; age range, 50–74 years; mean, 66.1 years ± 6.9; median, 67.5 years) with stage IA, biopsy-proven NSCLC were enrolled in a prospective, multicenter clinical trial. Lesion diameter ranged 1.0–3.0 cm (mean, 2.2 cm ± 0.7). All patients were considered unfit for surgery and radical radiotherapy. CT-guided RFA was performed under conscious sedation by using a 150-W generator and expandable multi-array needles (RITA Medical Systems, Mountain View, CA). Follow-up period ranged 1–14.5 months (mean, 8.2 months ± 4.9) and included CT examinations performed 1 and 3 months after the procedure and at 3-month intervals thereafter. Results: RFA was technically feasible in all 14 patients. CT obtained 1 month after RFA showed a round, ground-glass density area encompassing the treated lesion in all cases. Nine (82%) of 11 patients who were followed up for at least 6 months after RFA showed progressive shrinkage of the treated lesion on CT scans, with no signs of local recurrence. Complete ablation of treated tumors was confirmed by the absence of tumor re-growth over a follow-up period of 1 year or more in 7 patients. Two patients with local tumor progression on follow-up CT scans required repeated RFA. Major complications consisted of pneumothorax (n=3) and pleural effusion (n=1) requiring drainage. Pulmonary function tests and quality of life questionnaires did not show any significant decline with respect to baseline. At the time of the analysis, 12 patients were alive, and 2 patients were dead. Preliminary survival analysis showed a 1-year overall survival rate of 81%, and a 1-year cause-specific survival rate of 100%. Conclusions: Percutaneous RFA yields high local tumor control rates in patients with stage IA NSCLC, and is associated with acceptable morbidity. RFA might prove a viable alternate or complementary treatment method for stage IA NSCLC in patients without surgical prospects. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration RITA Medical Systems