Laparoscopic noninferior to open surgery for low rectal cancer

The disease-free survival outcome in patients with low rectal cancer who receive laparoscopic surgery compares favourably with that in those who receive open surgery, according to a study.

For the study, researchers enrolled 1,070 adults with histologically confirmed cT1–2N0, cT3–4aN0, or cT1–4aN1–2 rectal adenocarcinoma within 5 cm from the dentate line. These patients were randomly assigned to undergo laparoscopic surgery or open surgery. Investigators, patients, and statisticians were not masked to group allocation.

The primary outcome was 3-year disease-free survival. Analyses were performed in the modified intention-to-treat population, which excluded patients with distant metastasis discovered during surgery as well as those who did not undergo surgery or underwent local resection only.

A total of 1,039 patients (median age 57 years, 60 percent male) were included in the modified intention-to-treat analysis. Of these, 685 patients were in in the laparoscopic surgery group and 354 were in the open surgery group.

The 3-year disease-free survival was 81.4 percent in the laparoscopic surgery group and 79.8 percent in the open surgery group (hazard ratio [HR], 0.92, 95 percent confidence interval [CI], 0.69–1.23; p=0.56). The between-group difference of 1.60 percent (one-sided 97·5% CI –3·34 to ∞) met the criteria for noninferiority (p<0.0001).

The 3-year overall survival was also similar in the laparoscopic and open surgery groups (91.7 percent vs 93.7 percent; hazard ratio [HR], 1.34, 95 percent CI, 0.82–2.19; p=0.24). The same was true for the 3-year locoregional recurrence (3.7 percent vs 2.3 percent, respectively; HR, 1.64, 95 percent CI, 0.74–3·63; p=0.22) and the 5-year overall survival (84.6 percent vs 86.6 percent; HR, 1.16, 95 percent CI, 0.82–1.64; p=0.41).

The findings provide evidence for the use of laparoscopic surgery for low rectal cancer, the researchers said.