Laparoscopically assisted versus open colectomy for colon cancer.

Abstract

Nelson et al. report on the Clinical Outcomes of Surgical Therapy (COST) trial, which compared laparoscopically assisted colectomy with open colectomy for colon cancer (May 13 issue).¹ Unfortunately, the methods described in their article fail to support the claim of noninferiority,² for several reasons. First, the authors do not explicitly define a noninferiority boundary. Second, the statistical methods described in the article are those of a failed superiority trial rather than a noninferiority trial. Third, one approach to demonstrating noninferiority is to show that the upper limit of the one-sided 95 percent confidence interval for the hazard ratio is less than the noninferiority boundary. We have calculated that this value is 1.16 for the risk of death and 1.11 for the risk of recurrence with laparoscopic treatment.