Long-term outcomes of the australasian randomized clinical trial comparing laparoscopic and conventional open surgical treatments for colon cancer: the Australasian Laparoscopic Colon Cancer Study trial

Abstract

Objective: : We report a multicentered randomized controlled trial across Australia and New Zealand comparing laparoscopic-assisted colon resection (LCR) with open colon resection (OCR) for colon cancer.

Background: : Colon cancer is a significant worldwide health issue. This trial investigated whether the short-term benefits associated with LCR for colon cancer could be achieved safely, without survival disadvantages, in our region.

Methods: : A total of 601 patients with potentially curable colon cancer were randomized to receive LCR or OCR. Primary endpoints were 5-year overall survival, recurrence-free survival, and freedom from recurrence rates, compared using an intention-to-treat analysis.

Results: : On April 5, 2010, 587 eligible patients were followed for a median of 5.2 years (range, 1 week-11.4 years) with 5-year confirmed follow-up data for survival and recurrence on 567 (96.6%). Significant differences between the 2 trial groups were as follows: LCR patients were older at randomization, and their pathology specimens showed smaller distal resection margins; OCR patients had some worse pathology parameters, but there were no differences in disease stages. There were no significant differences between the LCR and OCR groups in 5-year follow-up of overall survival (77.7% vs 76.0%, P = 0.64), recurrence-free survival (72.7% vs 71.2%, P = 0.70), or freedom from recurrence (86.2% vs 85.6%, P = 0.85).

Conclusions: : In spite of some differences in short-term surrogate oncological markers, LCR was not inferior to OCR in direct measures of survival and disease recurrence. These findings emphasize the importance of long-term data in formulating evidence-based practice guidelines.

Trial registration: ClinicalTrials.gov NCT00202111.