Elsevier

The Lancet Oncology

Volume 10, Issue 1, January 2009, Pages 44-52
The Lancet Oncology

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Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial

https://doi.org/10.1016/S1470-2045(08)70310-3Get rights and content

Summary

Background

Laparoscopic surgery for colon cancer has been proven safe, but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer. The aim of the COlon cancer Laparoscopic or Open Resection (COLOR) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer.

Methods

Between March 7, 1997, and March 6, 2003, patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m2 were randomly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority randomised trial. Disease-free survival at 3 years after surgery was the primary outcome, with a prespecified non-inferiority boundary at 7% difference between groups. Secondary outcomes were short-term morbidity and mortality, number of positive resection margins, local recurrence, port-site or wound-site recurrence, and blood loss during surgery. Neither patients nor health-care providers were blinded to patient groupings. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00387842.

Findings

During the recruitment period, 1248 patients were randomly assigned to either open surgery (n=621) or laparoscopic surgery (n=627). 172 were excluded after randomisation, mainly because of the presence of distant metastases or benign disease, leaving 1076 patients eligible for analysis (542 assigned open surgery and 534 assigned laparoscopic surgery). Median follow-up was 53 months (range 0·03–60). Positive resection margins, number of lymph nodes removed, and morbidity and mortality were similar in both groups. The combined 3-year disease-free survival for all stages was 74·2% (95% CI 70·4–78·0) in the laparoscopic group and 76·2% (72·6–79·8) in the open-surgery group (p=0·70 by log-rank test); the difference in disease-free survival after 3 years was 2·0% (95% CI −3·2 to 7·2). The hazard ratio (HR) for disease-free survival (open vs laparoscopic surgery) was 0·92 (95% CI 0·74–1·15). The combined 3-year overall survival for all stages was 81·8% (78·4–85·1) in the laparoscopic group and 84·2% (81·1–87·3) in the open-surgery group (p=0·45 by log-rank test); the difference in overall survival after 3 years was 2·4% (95% CI −2·1 to 7·0; HR 0·95 [0·74–1·22]).

Interpretation

Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95% CI for the difference just exceeded the predetermined non-inferiority boundary of 7%. However, the difference in disease-free survival between groups was small and, we believe, clinically acceptable, justifying the implementation of laparoscopic surgery into daily practice. Further studies should address whether laparoscopic surgery is superior to open surgery in this setting.

Funding

Ethicon Endo-Surgery (Hamburg, Germany) and the Swedish Cancer Foundation (grant number 4287-B01-03XCC).

Introduction

Cancer of the colon is the third most common cancer in men and women in the developed world,1 and resection is the only curative treatment. Traditionally, cancers of the colon were removed through large abdominal incisions. More than a decade ago, the first report on laparoscopic resection of colon cancer was published.2 Laparoscopic colectomy is associated with improved convalescence and decreased morbidity compared with open resection.3, 4, 5, 6 However, reports of tumour recurrence at the port sites after laparoscopic resection of colon cancer have questioned the oncological safety of laparoscopic surgery in patients with bowel cancer.7 Thus, disease-free survival after laparoscopic colectomy for cancer needs to be proven non-inferior to that after open resection of bowel cancer.

The European multicentre COlon cancer Laparoscopic or Open Resection (COLOR) trial aimed to assess disease-free survival and overall survival 3 years after laparoscopic surgery or open surgery for colon cancer. The short-term outcomes of the COLOR trial have been published previously.6 Here, we present the data for long-term outcome.

Section snippets

Patients and procedures

Patients with colon cancer presenting at 29 participating hospitals in Europe were considered for inclusion in the trial. Patients with a solitary adenocarcinoma, localised in the caecum, ascending colon, descending colon, or sigmoid colon above the peritoneal deflection, who were aged 18 years or more, and who provided written informed consent, were eligible for random assignment to either laparoscopic or open surgery. Exclusion criteria included: a body-mass index (BMI) greater than 30 kg/m2;

Results

Between March 7, 1997, and March 6, 2003, 1248 patients were randomly assigned to either laparoscopic or open surgery. 153 patients were excluded after randomisation for various reasons (figure 1) and 19 patients were lost to follow-up. Of the 1076 patients who were available for analysis, 542 had an open colectomy and 534 had a laparoscopic colectomy. The average number of patients included per centre was 37, with a median follow-up in the laparoscopic group of 52 months (SD 17·0; range

Discussion

Data from the COLOR trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy, because the upper limit of the 95% CI for the difference just passed the predetermined non-inferiority boundary of 7%. However, in a per-protocol analysis, done as per CONSORT guidelines to prevent a false conclusion of non-inferiority,11 in which those patients who were randomly assigned to laparoscopic surgery but were switched pre-operatively to receive open surgery were

References (19)

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