OA13.02 Video-Assisted Thoracoscopic Surgery vs. Thoracotomy for Non-Small Cell Lung Cancer: Survival Outcome of a Randomized Trial

Abstract

Video-assisted thoracoscopic surgery (VATS) has been widely used in the treatment of early-stage non–small cell lung cancer (NSCLC). However, there has not been a robust randomized control trial (RCT) to confirm the non-inferiority of VATS to open lobectomy in term of oncologic efficacy. Therefore, a large multicenter RCT in China was designed and initiated to verify the role of VATS. A phase 3 RCT was undertaken at five thoracic surgery tertiary centers in China. Patients aged 18-75 years old who were diagnosed of clinically early-stage NSCLCs were randomized in a 1:1 ratio into VATS and thoracotomy groups. Radical lobectomy plus hilar and mediastinal lymph node dissection was the standard surgical intervention. The primary end-point of study was 5-year overall survival (OS). The secondary end-points including 5-year disease-free survival (DFS) and cancer relapse rates would also be reported here. Analysis was by intention to treat. This study is registered with the ClinicalTrials.gov, number NCT01102517. A total of 508 patients were recruited between January 2008 and March 2014. The final follow-up for 5-year survival analysis was completed in March 2019. And 432 patients were eligible for analysis (222 cases in VATS group and 210 cases in thoracotomy group). The cancer relapse (recurrence and metastasis) rates were 39.2% in VATS group and 36.7% in thoracotomy group respectively (P=0.621). Patients who received VATS lobectomies had a similar 5-year DFS to those who underwent open surgery (58% versus 62%, P=0.686). Finally, the 5-year OS rates were of no significant difference between VATS and thoracotomy groups (74% versus 71%, P=0.497). The non-inferiority of VATS to thoracotomy lobectomy was confirmed in our RCT in terms of oncologic efficacy for clinically early-stage NSCLCs.