Franks Kevin N, McParland Lucy, Webster Joanne, Baldwin David R, Sebag-Montefiore David, Evison Matthew, Booton Richard, Faivre-Finn Corinne, Naidu Babu, Ferguson Jonathan, Peedell Clive, Callister Matthew E J, Kennedy Martyn, Hewison Jenny, Bestall Janine, Gregory Walter M, Hall Peter, Collinson Fiona, Olivier Catherine, Naylor Rachel, Bell Sue, Allen Peter, Sloss Andrew, Snee Michael
Leeds Cancer Centre, St James's University Hospital, Leeds, UK
Leeds Institute of Medical Research, University of Leeds, Leeds, UK.
Eur Respir J. 2020 Nov 12;56(5). doi: 10.1183/13993003.00118-2020. Print 2020 Nov.
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.
立体定向消融放疗（SABR）是治疗医学上无法手术的外周I期非小细胞肺癌（NSCLC）的一种成熟疗法。以往的非随机证据支持SABR可作为手术的替代方案，但缺乏高质量的随机对照试验（RCT）证据。SABRTooth研究旨在确定英国的一项III期RCT是否可行。
SABRTooth是一项英国多中心随机对照可行性研究，针对被认为手术并发症风险较高的外周I期NSCLC患者。计划将54例患者按1:1随机分为SABR组或手术组。主要结局是每月平均入组率。
2015年7月至2017年1月期间，318例患者被纳入研究，其中205例（64.5%）被判定不符合条件。在106例（33.3%）被评估为符合条件的患者中，24例（22.6%）患者被随机分为SABR组（n = 14）或手术组（n = 亦或10）。不参与的一个关键原因是治疗偏好，43例（41%）患者更喜欢非手术治疗，19例（18%）患者更喜欢手术治疗。每月平均入组率为1.7例患者，而目标是3例。15例患者接受了分配的治疗：SABR组n = 12，手术组n = 3。
我们得出结论，在国民医疗服务体系中，对高风险患者进行SABR与手术之间的III期RCT是不可行的。患者已有既定的治疗偏好，这是招募患者的一个障碍。相当一部分被随机分配到手术组的患者拒绝并选择了SABR。SABR仍然是手术的替代方案，需要新的研究方法来确定哪些患者能从非手术方法中获益。
