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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

Bagshaw, Philip F. FRACS*; Allardyce, Randall A. PhD*; Frampton, Christopher M. PhD; Frizelle, Francis A. FRACS*; Hewett, Peter J. FRACS§¶; McMurrick, Paul J. FRACS; Rieger, Nicholas A. FRACS§¶; Smith, J. Shona MA; Solomon, Michael J. FRACS#; Stevenson, Andrew RL. FRACS**; the Australasian Laparoscopic Colon Cancer Study Group

doi: 10.1097/SLA.0b013e3182765ff8
Randomized Controlled Trial

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.

Five-year follow-up of patients for the Australasian randomized clinical trial comparing laparoscopic and conventional open surgical treatments for colon cancer (the Australasian Laparoscopic Colon Cancer Study trial) showed similar overall and disease-free survival and recurrence rates between the 2 treatments, despite some differences in short-term surrogate markers of oncological equivalence.

*Departments of Surgery

Medicine University of Otago

Academy of Endosurgery, Christchurch, New Zealand

§¶Division of Surgery, The Queen Elizabeth Hospital, Woodville and the University of Adelaide, South Australia

Department of Surgery, Monash University and Cabrini Hospital, Malvern, Victoria

#Department of Colon & Rectal Surgery, Royal Prince Alfred Hospital and Surgical Outcomes Research Centre (SOuRCe), University of Sydney

**Department of Colon and Rectal Surgery, Royal Brisbane & Women's Hospital, Herston, Australia

††Participating members of the Australasian Laparoscopic Colon Cancer Study Group are listed under Acknowledgements.

Correspondence (No reprints will be available from the authors): Philip F. Bagshaw, Department of Surgery, University of Otago, Christchurch Hospital, Private Bag No. 4710, Christchurch 8140, New Zealand. E-mail: bagshaw@clear.net.nz

This trial was conducted according to institutional and ethical rules and has been registered at clinicaltrials.gov number NCT00202111 and with Australian Clinical Trials Registry number ACTRN012605000103662.

Disclosure: Principle funding for the trial came from the Health Research Council of New Zealand (No 97/154, 04/102) and the National Health and Medical Research Council of Australia (ID 207815, 349381). Some additional funding was provided by: The Robert McLelland Trust, Trust Bank Canterbury, The J.R. Mackenzie Trust, Johnson & Johnson Medical (New Zealand), Johnson & Johnson Medical Pty Ltd (Australia), and The Canterbury Medical Research Foundation. The authors declare that they have no conflicts of interest.

© 2012 Lippincott Williams & Wilkins, Inc.