Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: Results of a prospective multicenter phase II trial

Background: A prospective multicenter phase II trial to evaluate the survival outcomes of percutaneous radiofrequency ablation (RFA) for patients with stage IA non-small cell lung cancer (NSCLC), ineligible for surgery. Methods: Patients with a biopsy-proven stage IA NSCLC, staging established by a positron emission tomography-computed tomography (PET-CT), were eligible. The primary objective was to evaluate the local control of RFA at 1-year. Secondary objectives were 1- and 3-year overall survival (OS), 3-year local control, lung function (prior to and 3months after RFA) and quality of life (prior to and 1month after RFA). Results: Of the 42 patients (mean age 71.7 y) that were enrolled at six French cancer centers, 32 were eligible and assessable. Twenty-seven patients did not recur at 1 year corresponding to a local control rate of 84.38% (95% CI, [67.21-95.72]). The local control rate at 3years was 81.25% (95% CI, [54.35-95.95]). The OS rate was 91.67% (95% CI, [77.53-98.25]) at 1year and 58.33% (95% CI, [40.76-74.49]) at 3years. The forced expiratory volume was stable in most patients apart from two, in whom we observed a 10% decrease. There was no significant change in the global health status or in the quality of life following RFA. Conclusion: RFA is an efficient treatment for medically inoperable stage IA NSCLC patients. RFA is well tolerated, does not adversely affect pulmonary function and the 3-year OS rate is comparable to that of stereotactic body radiotherapy, in similar patients.