A Randomized Trial of Rofecoxib for the Chemoprevention of Colorectal Adenomas

Abstract

In this randomized trial, rofecoxib significantly reduced the risk of colorectal adenomas, but also had serious toxicity.

Cancer Prevention Research: Back to the Future

“…High-dose aspirin prevented colorectal cancer that expresses COX-2 (95), consistent with results of three important RCTs of COX-2-selective inhibitors: the Adenomatous Polyp Prevention on Vioxx (APPROVe), Adenoma Prevention with Celecoxib (APC), and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials, all stopped early (and before published efficacy results) because of interim analyses in APPROVe and APC showing unexpected increases in cardiovascular event rates (96)(97)(98). The significant colorectal-adenoma reductions in each of these trials were reported in 2006 (96,99,100). In 2008, a pooled analysis found that people with a low baseline cardiovascular risk seemed to have no increased risk of serious cardiovascular events in major celecoxib RCTs (101).…”

Clinical Prevention of Recurrence of Colorectal Adenomas by the Combination of Difluoromethylornithine and Sulindac: An Important Milestone

“…Such a marked level of preventive activity has never been seen before in any clinical chemoprevention trial involving any organ site. The practical clinical chemopreventive activity of the DFMO-sulindac combination reported here is clearly superior to that which has previously been shown for any of the nonsteroidal anti-inflammatory drugs, including aspirin, celecoxib, and rofecoxib, for suppression of adenomas (4)(5)(6)(7)(8).…”

Celecoxib promotes degranulation of CD8+ T cells in HPV-induced lesions of K14-HPV16 transgenic mice

“…However, these drugs have very low specificity. Selective COX-2 inhibitors such as celecoxib and rofecoxib have already been used to prevent the development of colorectal adenomas [42,43]. Furthermore, celecoxib showed promising results in a tumour model of human colon cancer when combined with chemotherapeutic drugs [44].…”