4.7 Article

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

期刊

ANNALS OF SURGERY
卷 256, 期 6, 页码 915-919

出版社

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/SLA.0b013e3182765ff8

关键词

clinical trial; colon cancer; colon surgery; laparoscopy

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资金

  1. Health Research Council of New Zealand [97/154, 04/102]
  2. National Health and Medical Research Council of Australia [207815, 349381]
  3. Robert McLelland Trust
  4. Trust Bank Canterbury
  5. J.R. Mackenzie Trust
  6. Johnson & Johnson Medical (New Zealand)
  7. Johnson & Johnson Medical Pty Ltd (Australia)
  8. Canterbury Medical Research Foundation

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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.

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