Abstract
BackgroundThe appropriateness of lobectomy for all elderly patients is controversial. Meanwhile, sublobar resection is associated with reduced operative risk, better preservation of pulmonary function, and a better quality of life, constituting a potential alternative to standard lobectomy for elderly patients with early-stage non-small cell lung cancer (NSCLC). To date, no randomized trial comparing sublobar resection and lobectomy focusing on elderly patients has been reported. We hypothesized that for patients at least 70 years old with clinical stage T1N0M0 NSCLC, sublobar resection is non-inferior to lobectomy for 3-year disease-free survival (DFS).Methods/designThis is a prospective, randomized, controlled multicenter non-inferiority trial with two study arms: sublobar resection and lobectomy groups. Comprehensive geriatric assessments will be acquired for each patient. A total of 339 subjects will be enrolled on the basis of power calculations, and participants followed up every 6 months post-operation for 3 years. In case of relapse, survival follow-up will be continued until 5 years or death. Pulmonary function testing will be performed at 6, 12, and 36 months post-operation. The primary outcome is 3-year DFS; secondary endpoints include peri-operative complications and mortality, hospitalization time, post-operative ventilator time, overall survival, 3-year recurrence rates, post-operative pulmonary function, quality of life, geriatric assessment data, and 4-year mortality index.DiscussionThe present study is the only prospective, multicenter, randomized controlled trial comparing sublobar resection and lobectomy for elderly patients. The therapeutic outcomes of sublobar resection will be evaluated in comparison with lobectomy for elderly patients (≥70 years) with early-stage NSCLC.Trial registration numberNCT02360761: 01/24/2015 (ClinicalTrials.gov)
Highlights
The appropriateness of lobectomy for all elderly patients is controversial
The therapeutic outcomes of sublobar resection will be evaluated in comparison with lobectomy for elderly patients (≥70 years) with early-stage non-small cell lung cancer (NSCLC)
The history of lung cancer operation began with pneumonectomy, which was first performed by Gramham in 1933 [35] and regarded as a standard procedure
Summary
The development course of the surgical procedure for NSCLC has been quite similar to that of breast cancer, going through a revolution from extensive resection to better organ preservation. The present study is so far the only prospective, multicenter, randomized controlled trial comparing sublobar resection and lobectomy for elderly patients that aims to identify the most appropriate surgical approach for NSCLC at an early stage, to find the balance between radical effect and operation risk, and to assess survival period and life quality. If the proposed study hypothesis is verified in the current trial, sublobar resection will be demonstrated to achieve equivalent therapeutic outcomes compared with lobectomy for elderly patients (≥70 years) with NSCLC at an early stage, with respect to DFS time, hospital stay, intubation time, peri-operative complication, death rate, overall survival rate, recurrence and metastasis rates within post-operative 3 and 5 years, and pulmonary function 6, 12, and 36 months after operation, respectively.
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