STARS wars.

Top Line: The phase 3 STARS and ROSEL trials were closed due to poor accrual and their pooled analysis included just 58 patients.

The Study: After closure of the original STARS, a revised STARS trial was opened at MDACC as a prospective, single-arm trial of SBRT for operable, stage I NSCLC. Here we have 5-year outcomes from the revised, single-arm version of STARS that doesn’t include patients from the original trial. Everyone underwent PFT’s and thoracic surgeon eval to determine operability. Peripheral tumors received 54 Gy in 3 fractions and central tumors (but not those overlapping central structures) received 50 Gy in 4 fractions to the PTV with a simultaneous integrated boost of 60 Gy to the GTV. Radiation was delivered on sequential days. At total of 80 patients were enrolled and treated and most had peripherally located adenocarcinomas. Overall survival at 3 and 5 years was 91% and 87% with SBRT compared to 91% and 84% with surgery. Progression-free survival at 3 and 5 years was 80% and 77% with SBRT compared to 88% and 80% with surgery. Cancer-specific survival at 3 and 5 years was 95% and 92% with SBRT compared to 97% and 93% with surgery. All survival comparisons were deemed non-inferior. There were differences in recurrence, though. At 5 years, the cumulative incidence of any recurrence verged on being significantly higher with SBRT (17.6% vs 8%). This was driven by an increase in regional recurrences with SBRT (12.5% vs 2.7%). Although, 10% of patients in the surgery cohort had occult mediastinal disease. Local recurrence (6.3% vs 1.3%) and distant recurrence (8.8 vs 4%) were numerically higher in the SBRT cohort. Importantly, many local and regional recurrences were salvageable.

TBL: SBRT is a good treatment option for patients with operable early-stage NSCLC with comparable survival outcomes to surgery at a high-volume center. | Chang, Lancet Oncol 2021