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

Abstract

<jats:sec><jats:title>Objectives</jats:title><jats:p>Stereotactic Ablative Radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I non-small cell lung cancer (NSCLC). Previous non-randomised 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.</jats:p></jats:sec><jats:sec><jats:title>Design and Methods</jats:title><jats:p>SABRTooth was a UK multi-centre, randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications. Fifty-four patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible. Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10). A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of 3. Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>We conclude that a phase III RCT randomising higher-risk patients between SABR and surgery is not feasible in the National Health Service (NHS). 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 non-surgical approach.</jats:p></jats:sec>

The US Preventive Services Task Force Recommendation on Lung Cancer Screening

“…Although a large randomized trial directly comparing SABR with surgery (either lobectomy or limited resection) would be ideal, differences in complication or mortality profiles and patient or physician biases make randomization to invasive vs noninvasive therapies difficult, and planned studies have failed to accrue patients (STARS [NCT00840749], ROSEL [NCT00687986], and ACOSOG [NCT01336894]). A UK feasibility study concluded that a phase 3 trial of surgery vs SABR was not possible due to patient preferences to undergo SABR when presented both options . Nevertheless, 2 studies, STABLE-MATES (NCT02468024) and VALOR (NCT02984761), are ongoing to address this question.…”

Stereotaktisch ablative Strahlentherapie für operable nichtkleinzellige Bronchialkarzinome in Stadium I (überarbeitete STARS-Studie): Langzeitergebnisse einer einarmigen, prospektiven Studie mit Vergleich zur Operation

“…Eine relevante Limitation bei der Erhebung von randomisierten Daten zum Vergleich der SBRT und der operativen Therapie stellt die mangelnde Rekrutierung aufgrund des Patienten- oder Behandlerwunschs dar (RTOG 1021, STARS: NCT00840749; ROSEL: NCT00687986, SABRTooth [ 3 ]). Nichtsdestotrotz konnten Chang et al.…”

Stereotactic Ablative Radiotherapy versus Video-Assisted Lobectomy for Operable Stage I Non-small-cell Lung Cancer: Study Protocol for an Emulated Target Trial

“…Several attempts to conduct randomized controlled trials (RCT) to directly compare SABR with VATS in treating operable early stage NSCLC patients have been unsuccessful. The UK-based SABRTooth trial, for example, was found to be infeasible, while slow accrual hindered the progress of the STARS and ROESEL trials (12). Despite these challenges, a pooled analysis of the 58 patients recruited from the STARS and ROESEL trials was conducted (13).…”