25981812
BACKGROUND	The standard of care for operable , stage I , non-small-cell lung cancer ( NSCLC ) is lobectomy with mediastinal lymph node dissection or sampling .
BACKGROUND	Stereotactic ablative radiotherapy ( SABR ) for inoperable stage I NSCLC has shown promising results , but two independent , randomised , phase 3 trials of SABR in patients with operable stage I NSCLC ( STARS and ROSEL ) closed early due to slow accrual .
BACKGROUND	We aimed to assess overall survival for SABR versus surgery by pooling data from these trials .
METHODS	Eligible patients in the STARS and ROSEL studies were those with clinical T1-2a ( < 4 cm ) , N0M0 , operable NSCLC .
METHODS	Patients were randomly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling .
METHODS	We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint .
METHODS	Both trials are registered with ClinicalTrials.gov ( STARS : NCT00840749 ; ROSEL : NCT00687986 ) .
RESULTS	58 patients were enrolled and randomly assigned ( 31 to SABR and 27 to surgery ) .
RESULTS	Median follow-up was 402 months ( IQR 230-473 ) for the SABR group and 354 months ( 189-407 ) for the surgery group .
RESULTS	Six patients in the surgery group died compared with one patient in the SABR group .
RESULTS	Estimated overall survival at 3 years was 95 % ( 95 % CI 85-100 ) in the SABR group compared with 79 % ( 64-97 ) in the surgery group ( hazard ratio [ HR ] 014 [ 95 % CI 0017-1190 ] , log-rank p = 0037 ) .
RESULTS	Recurrence-free survival at 3 years was 86 % ( 95 % CI 74-100 ) in the SABR group and 80 % ( 65-97 ) in the surgery group ( HR 069 [ 95 % CI 021-229 ] , log-rank p = 054 ) .
RESULTS	In the surgery group , one patient had regional nodal recurrence and two had distant metastases ; in the SABR group , one patient had local recurrence , four had regional nodal recurrence , and one had distant metastases .
RESULTS	Three ( 10 % ) patients in the SABR group had grade 3 treatment-related adverse events ( three [ 10 % ] chest wall pain , two [ 6 % ] dyspnoea or cough , and one [ 3 % ] fatigue and rib fracture ) .
RESULTS	No patients given SABR had grade 4 events or treatment-related death .
RESULTS	In the surgery group , one ( 4 % ) patient died of surgical complications and 12 ( 44 % ) patients had grade 3-4 treatment-related adverse events .
RESULTS	Grade 3 events occurring in more than one patient in the surgery group were dyspnoea ( four [ 15 % ] patients ) , chest pain ( four [ 15 % ] patients ) , and lung infections ( two [ 7 % ] ) .
CONCLUSIONS	SABR could be an option for treating operable stage I NSCLC .
CONCLUSIONS	Because of the small patient sample size and short follow-up , additional randomised studies comparing SABR with surgery in operable patients are warranted .
BACKGROUND	Accuray Inc , Netherlands Organisation for Health Research and Development , NCI Cancer Center Support , NCI Clinical and Translational Science Award .

