Laparoscopic Surgery Shows Noninferior DFS Vs Open Surgery in Rectal Cancer

“These results provide robust support for the utilization of laparoscopic-assisted surgery in the treatment of low rectal cancer," according to Pan Chi, MD, FRCS.

Laparoscopic-assisted surgery demonstrated noninferiority with respect to disease-free survival (DFS) compared with conventional open surgery in the treatment of patients with low rectal cancer, according to findings from the randomized Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum (LASRE) trial (NCT01899547) presented at the 2024 Gastrointestinal Cancers Symposium.

Among patients across all disease stages, the 3-year DFS rate was approximately 81% with laparoscopic surgery compared with 79% using open surgery (HR, 0.92; 95% CI, 0.69-1.23; P = .558). The 3-year DFS rates in each respective arm were 86% vs 84% among those with clinical stage I disease (HR, 0.86; 95% CI, 0.49-1.52; P = .605) and 78% vs 76% for patients with stage II or III disease (HR, 0.94; 95% CI, 0.67-1.33; P = .74).

The 3-year overall survival (OS) rates were comparable between the laparoscopic and open surgery arms across the entire study population (HR, 1.34; 95% CI, 0.82-2.19; P = .243). Moreover, similar OS rates were observed between surgical cohorts in the both the stage I disease subgroup (HR, 1.22; 95% CI, 0.43-3.47; P = .705) and stage II/III disease subgroup (HR, 1.39; 95% CI, 0.79-2.43; P = .247).

There were no significant differences in 3-year locoregional recurrence rates between the laparoscopic and open surgery groups across all disease stages (HR, 1.66; 95% CI, 0.75-3.67; P = .209). Additionally, similar locoregional recurrence incidence was highlighted between both arms in the stage I disease arm (HR, 0.63; 95% CI, 0.17-2.35 P = .487) and in the stage II/III disease arm (HR, 2.72; 95% CI, 0.93-7.95; P = .057).

“Laparoscopic-assisted surgery performed by experienced surgeons was found to be noninferior in achieving 3-year DFS rates compared [with] open surgery for low rectal cancer,” presenting author Pan Chi, MD, FRCS, a professor in the Department of Colorectal Surgery at Fujian Medical University Union Hospital in China, said. “These results provide robust support for the utilization of laparoscopic-assisted surgery in the treatment of low rectal cancer.”

Investigators of the multi-center, noninferiority LASRE trial assessed patients at 22 tertiary hospitals across China. Patients 18 to 75 years old with a pathological diagnosis of rectal adenocarcinoma and no evidence of pelvic lateral lymph nodes or distant metastasis were assigned 2:1 to receive laparoscopic or open surgery. Investigators stratified patients based on clinical stage I or II/II disease.

The trial’s primary end point was 3-year DFS. Secondary end points included OS, locoregional recurrence, and recurrence as determined via imaging analysis or biopsy.

Overall, 1070 patients were randomly assigned to receive laparoscopic surgery (n = 712) or open surgery (n = 358). In the laparoscopic and open surgery groups, respectively, 701 and 357 patients proceeded with surgery, while 11 and 1 patients each in each arm refused surgery. Additionally, 685 and 354 patients in each respective arm made up the modified intent-to-treat population.

The median age was 58.0 years (IQR, 50.0-64.0) in the laparoscopy group compared with 57.0 years (IQR, 50.0-63.0) for those who received open surgery. Most patients in each respective group were male (59.7% vs 59.6%), had an ECOG performance status of 0 (76.0% vs 74.9%), no comorbidities (73.1% vs 72.6%), and stage II/III disease (63.2% vs 63.8%). Additionally, 95.8% of patients in the laparoscopy surgery group received prior treatment with chemoradiotherapy compared with 96.9% of those who underwent open surgery.

Locoregional recurrence affected 2.9% of patients in the laparoscopy group and 2.0% in the open surgery group (difference, 0.94; 95% CI, –1.35 to 2.79; P = .37). Additionally, locoregional recurrence with distant metastasis occurred in 0.7% and 0.3% of each arm (difference, 0.45; 95% CI, –92 to 1.44; P = .67), and distant metastasis only was reported in 12.3% and 15.8% (difference, –3.56; 95% CI, –8.29 to 0.79; P = .11). Investigators highlighted deaths in 8.2% of patients in the laparoscopy arm compared with 6.2% in the open surgery group (difference, 1.96; 95% CI, –1.56 to 5.05; P = .26).

Reference

Chi P, Su X, Xu J, et al. Effect of laparoscopy-assisted vs open surgery on 3-year disease-free survival in patients with low rectal cancer: the LASRE randomized clinical trial. J Clin Oncol. 2024;42(suppl 3):8. doi:10.1200/JCO.2024.42.3_suppl.8