Similar Outcomes With Laparoscopic vs Open Resection in Rectal Cancer
In the COLOR II study reported in The New England Journal of Medicine, Bonjer et al found similar rates of locoregional recurrence and disease-free and overall survival with laparoscopic vs open resection of rectal cancer.
Study Details
In the trial, 1,044 patients from 30 sites in 8 countries in Europe, North America, and Asia were randomly assigned 2:1 between January 2004 and May 2010 to undergo laparoscopic resection (n = 699) or open resection (n = 345). Patients had to have a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, no invasion of adjacent tissues, and no distant metastases. The primary endpoint was locoregional recurrence at 3 years on intention-to-treat analysis.
Locoregional Recurrence
Conversion from laparoscopic to open surgery occurred in 16% of the laparoscopy group. At 3 years, locoregional recurrence rates were 5.0% in both groups (difference = 0%, 90% confidence interval [CI] = −2.6 to 2.6). Recurrence rates were 3.5% in the laparoscopy group vs 2.9% in the open surgery group (difference = 0.6%, 90% CI = −2.9 to 4.1) for upper rectal cancers, 6.5% vs 2.4% (difference = 4.1%, 90% CI = 0.7−7.5) for middle rectal cancers, and 4.4% vs 11.7% (difference = −7.3%, 90% CI = −13.9 to −0.7) for lower rectal cancers.
Disease-free survival rates were 74.8% in the laparoscopy group vs 70.8% in the open surgery group (difference = 4.0%, 95% CI = −1.9 to 9.9). Overall survival rates were 86.7% vs 83.6% (difference = 3.1%, 95% CI = −1.6 to 7.8). Distant metastases at 3 years were identified in 19.1% vs 22.1% of patients, including a port-site metastasis in a patient in the laparoscopy group and tumor recurrence in a laparotomy wound in a patient in the open surgery group.
The investigators concluded: “Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery.”
H. Jaap Bonjer, MD, PhD, is the corresponding author of The New England Journal of Medicine article.
The study was funded by Ethicon Endo-Surgery Europe and others. For full disclosures of the study authors, visit www.nejm.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
