Purpose
This study evaluates the two-year overall survival (OS), adverse event rate, local control rate and impact on pulmonary function tests (PFTs) in medically inoperable patients with stage IA NSCLC undergoing CT-guided RFA in a prospective multi-center trial.
Methods
54 patients M:F=25:29, median age/range= 76/60–89 were enrolled from 16 US centers 51 patients were eligible (biopsy proven stage IA NSCLC and deemed medically inoperable by board certified thoracic surgeon) for evaluation. PFTs were obtained within 60 days of RFA, 3 and 24 months after RFA. Adverse events were recorded and categorized. Patients were followed by CT and FDG PET. Local control rate and recurrence patterns were analyzed.
RESULTS
The OS rate was 86.3% at one year and 69.8% at two years. Local tumor recurrence free rate was 68.9% at one year and 59.8% at two years and was worse for tumors >2 cm. In the 19 patients with local recurrence, 11 had retreatment with RFA, nine had radiation and three had chemotherapy. There were 21 grade 3, two grade 4 and one grade 5 AEs in 12 patients within the first 90 days after RFA. None of the grade 4 and 5 AEs were attributed to the RFA. There was no significant change in the FEV1 or DLCO after RFA. Tumor size less than 2.0 cm and performance status of 0–1 were associated with a statistically significant improved survival of 83% and 78% respectively, at two years.
CONCLUSIONS
RFA is a single minimally invasive procedure, that is well tolerated in medically inoperable patients, does not adversely affect PFTs and gives two year OS that is comparable to that reported following SBRT in similar patients.