Similar outcomes between laparoscopic and open surgery for rectal cancer [COLOR II trial]

1. There were no statistically significant differences in locoregional recurrence, disease-free survival or overall survival after 3 years between laparoscopic and open surgery for rectal cancer.

2. Disease-free survival was significantly higher among patients with stage III rectal cancer who had undergone laparoscopic surgery compared to those who had undergone open surgery.

Evidence Rating Level: 1 (Excellent)      

Study Rundown: Randomized trials have shown that laparoscopic surgery can achieve similar rates of long-term survival as open surgery for colon cancer, as well as favorable short-term outcomes including less pain, reduced blood loss, and improved recovery time. A growing body of evidence suggests that the same is true for rectal cancer, though this has not been definitively established.

The Colorectal Cancer Laparoscopic or Open Resection (COLOR) II study compared laparoscopic surgery against open surgery for rectal cancer. At 3 years after surgery, the locoregional recurrence was the same in both groups (5%), and there was no difference in disease-free or overall survival between the two groups.

This study is larger than two prior trials (CLASICC and COREAN) to look at this issue; the concordance of findings from these studies further lends credence to the conclusion that laparoscopic surgery is as safe and effective as open surgery in the treatment of rectal cancer.

Click to read the study, published today in NEJM

Relevant Reading: Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial; Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

In-Depth [randomized controlled trial]: COLOR II enrolled 1103 patients with rectal cancer between 2004 and 2010. Candidates for the trial had to have solitary rectal tumors within 15cm of the anal verge and be candidates for elective surgery. Patients with tumors extending through the wall of the rectum or involving adjacent tissues (T3 or T4 on imaging) were excluded. Participants were randomized in a 2:1 ratio to laparoscopic or open surgery.

The primary outcome was locoregional recurrence after 3 years. This was the same (5%) between both groups. Non-inferiority of laparoscopic surgery was established since the upper limit of the one-sided 95% confidence interval for the absolute difference was 2.6 percentage points, which did not exceed the pre-specified threshold of 5 percentage points for non-inferiority.

Secondary outcomes were disease-free and overall survival. Disease-free survival was 74.8% vs. 70.8% (95% CI for absolute difference -1.9 to 9.9) for laparoscopic and open surgery respectively. Overall survival was 86.7% vs. 83.6% (95% CI for absolute difference -1.6 to 7.8) for laparoscopic and open surgery respectively. Of note, disease-free survival was significantly higher among patients with stage III disease who had undergone laparoscopic surgery (64.9% vs. 52%, 95% CI for absolute difference 2.2 to 23.6).

Image: PD

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