Disease-free Survival and Local Recurrence After Laparoscopic-assisted Resection or Open Resection for Rectal Cancer

Abstract

Objective: The aim of the study was to determine the efficacy of laparoscopic rectal resection (Lap) versus open laparotomy and rectal resection (Open) for rectal cancer on locoregional recurrence (LRR) and disease-free survival (DFS) at 2 years. Summary background data: Although a Lap approach to colon cancer surgery may offer similar oncological outcomes to Open with potentially less morbidity, this remains to be clearly established for the treatment of rectal cancer. Methods: A randomized, multicenter noninferiority phase 3 trial of 475 patients with T1 to T3 rectal adenocarcinoma <15 cm from anal verge, given Lap or Open and followed for a minimum 2 years to assess LRR, DFS, and overall survival (OS). Results: Secondary endpoint analyses included 450 patients (95%) without metastases at baseline (mean age 64; 34% women) who received Lap (n = 225) or Open (n = 225). Median follow-up was 3.2 years (range: 0.1–5.4 yrs). LRR cumulative incidence at 2 years: Lap 5.4%; Open 3.1% [difference, 2.3%; 95% confidence interval (CI), −1.5% to 6.1%; hazard ratio (HR) 1.7; 95% CI, 0.74–3.9]. DFS at 2 years: Lap 80%; Open 82% (difference, 2.0%; 95% CI, −9.3% to 5.4%; HR for recurrence or death, 1.17; 95% CI, 0.81–1.68; P = 0.41). After adjustment for baseline factors HR = 1.07 (95% CI, 0.7–1.6). OS at 2 years: Lap 94%; Open 93% (difference 0.9%; 95% CI, −3.6% to 5.4%). Conclusions: Laparoscopic surgery for rectal cancer did not differ significantly from open surgery in effects on 2-year recurrence or DFS and OS. Confidence intervals included potentially clinically important differences favoring open resection, so that the combination of primary and secondary study endpoints may not support laparoscopic resection of rectal cancer as a routine standard of care and further follow-up is required.

Transanal total mesorectal excision for rectal cancer has been suspended in Norway

“…mesorectum has been observed in up to 46 per cent of patients after LaTME. Although two other randomized studies have reported non‐inferior survival rates after LaTME compared with open surgery, the newly published follow‐up of the ALaCaRT (Australasian Laparoscopic Cancer of the Rectum Trial) study, a non‐inferiority study of LaTME compared with open TME, advocated further observation of long‐term results after LaTME in order to define the standard of care for rectal cancer.…”

A propensity‐score‐matched analysis of laparoscopic vs open surgery for rectal cancer in a population‐based study

“…Both trials showed a higher success rate for open surgery; nevertheless, the validity of the composite end- point has not yet been demonstrated, and the trialists did not take the non-inferiority margin into account in the clinical interpretation of their findings. No differences for recurrence or overall survival at 2 years have been identified [28].…”

Oncologic results of conventional laparoscopic TME: is the intramesorectal plane really acceptable?

“…However, the oncologic inadequacy of the surgical specimen related to conventional laparoscopy should be accompanied by an effect on local recurrence and disease-free survival rates to be considered clinically relevant. This is not the actual scenario, since the mid-term (2-year follow-up) results of the ACOSOG Z6051 and ALaCaRT trials so far did not prove so [13,14].…”