Comparison between sublobar resection and lobectomy for the surgical treatment of elderly patients with early stage non-small-cell lung cancer (STEPS): an open label, multicentre, non-inferiority, randomised, phase 3 clinical trial

Background Sublobar resection is a potential alternative to lobectomy for elderly patients with early-stage non-small-cell lung cancer, with better short term outcomes and similar oncological outcomes. We aimed to compare sublobar resection and lobectomy in patients with clinical stage T1N0M0 non-small-cell lung cancer aged 70 years or older. Methods We did this prospective, open label, randomised, controlled, multicentre, non-inferiority, phase 3 trial (STEPS; registered with the Chinese Thoracic Oncology Group, number CTON1504) comparing sublobar resection and lobectomy for treatment of elderly patients with early-stage non-small-cell lung cancer. Patients were aged 70 years or older, with preoperative thoracic CT showing suspected peripheral non-small-cell lung cancer, clinical stage IA, consolidation to maximum tumour diameter ratio of 0·5 or higher, and were eligible for sublobar resection with sufficient margin. Intraoperative eligibility criteria included histologically confirmed invasive non-small-cell lung cancer, pathological exclusion of suspected lymph node involvement, and feasibility of sublobar resection in terms of surgical margin requirement. Patients gave informed consent, completed 4-year mortality index and comprehensive geriatric assessment if necessary, and had both forced expiratory volume in 1 s and diffusing capacity of the lungs for carbon monoxide of 50% or more in pulmonary function tests. Patients were excluded if they had a previous history of thoracic surgery and malignant tumour history within the past 5 years. We expect a total of 339 patients to be randomly assigned to the two treatment groups and participants will be followed-up every 6 months for 3 years. The primary outcome is 3-year disease-free survival (with a non-inferiority margin of 15%). The study will develop in accordance to the Declaration of Helsinki. Ethical Committee approval (Peking University Institutional Review Board) was obtained on Oct 30, 2014, before registration (reference number IRB00001052-13053). This trial is registered with ClinicalTrials, number NCT02360761. Findings As of Jan 29, 2016, 66 patients have been registered to the study; the accrual is slower than anticipated. One patient receiving sublobar resection died of a surgical complication. Interpretation To our knowledge, the present study is the only prospective, multicentre, randomised, controlled trial to compare sublobar resection and lobectomy for elderly patients (≥70 years) with early-stage non-small-cell lung cancer. Funding Medtronic Inc.