SABRTooth: a randomised controlled feasibility study of stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I nonsmall cell lung cancer considered to be at higher risk of complications from surgical resection.

Stereotactic ablative radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I nonsmall cell lung cancer (NSCLC). Previous nonrandomised evidence supports SABR as an alternative to surgery, but high-quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible. SABRTooth was a UK multicentre randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher risk of surgical complications. 54 patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates. Between July 2015 and January 2017, 318 patients were considered for the study and 205 (64.5%) were deemed ineligible. Out of 106 (33.3%) assessed as eligible, 24 (22.6%) patients were randomised to SABR (n=14) or surgery (n=10). A key theme for nonparticipation was treatment preference, with 43 (41%) preferring nonsurgical treatment and 19 (18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of three. 15 patients underwent their allocated treatment: SABR n=12, surgery n=3. We conclude that a phase III RCT randomising higher risk patients between SABR and surgery is not feasible in the National Health Service. Patients have pre-existing treatment preferences, which was a barrier to recruitment. A significant proportion of patients randomised to the surgical group declined and chose SABR. SABR remains an alternative to surgery and novel study approaches are needed to define which patients benefit from a nonsurgical approach.

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Copyright ©ERS 2020.

Déclaration de conflit d'intérêts

Conflict of interest: K.N. Franks has nothing to disclose. Conflict of interest: L. McParland has nothing to disclose. Conflict of interest: J. Webster has nothing to disclose. Conflict of interest: D.R. Baldwin has nothing to disclose. Conflict of interest: D. Sebag-Montefiore has nothing to disclose. Conflict of interest: M. Evison has nothing to disclose. Conflict of interest: R. Booton has nothing to disclose. Conflict of interest: C. Faivre-Finn has nothing to disclose. Conflict of interest: B. Naidu has nothing to disclose. Conflict of interest: J. Ferguson has nothing to disclose. Conflict of interest: C. Peedell has nothing to disclose. Conflict of interest: M.E.J. Callister has nothing to disclose. Conflict of interest: M. Kennedy has nothing to disclose. Conflict of interest: J. Hewison has nothing to disclose. Conflict of interest: J. Bestall has nothing to disclose. Conflict of interest: W.M. Gregory has nothing to disclose. Conflict of interest: P. Hall has nothing to disclose. Conflict of interest: F. Collinson has nothing to disclose. Conflict of interest: C. Olivier has nothing to disclose. Conflict of interest: R. Naylor has nothing to disclose. Conflict of interest: S. Bell has nothing to disclose. Conflict of interest: P. Allen has nothing to disclose. Conflict of interest: A. Sloss has nothing to disclose. Conflict of interest: M. Snee has nothing to disclose.