Laparoscopic-assisted vs open surgery for low rectal cancer: 5-year outcomes of the LASRE randomized clinical trial.

Abstract

e15630 Background: The long-term efficacy of laparoscopic versus open surgery for low rectal cancer has not yet been established. The primary outcome of 3-year disease free survival (DFS) have been published (Chi et al., ASCO GI 2024). Here, we presented the data of 5-year outcomes, including DFS and overall survival (OS) and locoregional recurrence. Methods: This is a multicenter, noninferiority trial. A total of 1070 patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery from November 2013 to June 2018. All analyses were performed on an modified intention-to-treat (mITT) basis. Results: The final analysis included 1039 patients (median age: 57 years, 620 men; 685 and 354 in laparoscopic and open groups, respectively). Clinical TNM stage was II/III in 659 patients, and I in the remaining 380 patients. The 5-year DFS rate was 76.4% in the laparoscopic group versus 75.6% in the open group (log-rank P = 0.766). The 5-year OS rate was 84.6% in the laparoscopic group versus 86.6% in the open group (log-rank P = 0.405). The 5-year locoregional recurrence rate was 5.5% and 3.1%, respectively (log-rank P = 0.079). Conclusions: The findings of the LASRE trial demonstrate that the noninferiority of laparoscopic surgery compared to open surgery for low rectal cancer, as evidenced by the 3-year outcomes, is sustained over a 5-year period when conducted by skilled surgeons. These results affirm laparoscopic surgery as a secure and minimally invasive option for the treatment of low rectal cancer. Clinical trial information: NCT01899547 .