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Study Published in the New England Journal of Medicine Shows Drug Reduces the Number of Pre-Cancerous Colorectal Polyps in People with Hereditary Disease

Study Published in the New England Journal of Medicine Shows Drug Reduces the Number of Pre-Cancerous Colorectal Polyps in People with Hereditary Disease
M. D. Anderson News Release 06/27/00

A study conducted at The University of Texas M. D. Anderson Cancer Center in Houston and St. Mark's Hospital in London shows the drug Celebrex® (celecoxib capsules) reduced the number of colorectal polyps by nearly one third in patients with familial adenomatous polyposis (FAP).

The study, published in the June 29 edition of the New England Journal of Medicine, was led by Dr. Gideon Steinbach, assistant professor of cancer prevention at M. D. Anderson.

"The study of Celebrex brings new hope to patients with FAP," says Dr. Steinbach. "This is the first clinical trial in human subjects to demonstrate that specifically blocking the COX-2 enzyme can impact human polyps and open the door to long-term studies of this approach to the prevention of pre-cancerous colon polyps. This study also serves as a model for research in colon cancer prevention because genes found in FAP are also responsible for most colon cancers in the general population."

FAP is a rare and devastating hereditary disease that affects one in every 10,000 people. Without surgical removal of the colon or colorectum, those with FAP have a nearly 100 percent risk of colon cancer by age 40 to 50. The disease is characterized by the development of hundreds to thousands of potentially pre-cancerous (adenomatous) polyps in the colon and rectum.

These polyps usually begin to appear in adolescence and early adulthood. Many of these polyps express high levels of the cyclooxygenase-2 (COX-2) enzyme and may be precursor lesions for colorectal cancer. A growing body of scientific evidence suggests COX-2 may play a critical role in the development and progression of adenomatous polyps.

Celebrex, a COX-2 specific inhibitor approved by the U.S. Food and Drug Administration (FDA) in December 1998 for the treatment of osteoarthritis and adult rheumatoid arthritis, also was approved as an oral adjunct to usual care (e.g., endoscopic surveillance and surgery) for FAP by the FDA in December 1999. It is not yet known if this medication can prevent progression to cancer.

The six-month clinical trial, sponsored by the National Cancer Institute's Division of Cancer Prevention in collaboration with Searle, now part of Pharmacia, and Pfizer, included 77 FAP patients with colorectal disease. The study showed that treatment with Celebrex, 400 mg twice daily, reduced the number of colorectal polyps by an average of 28 percent compared to 4.5 percent when treated with placebo in patients with FAP. The study further showed a more than 30 percent reduction in polyp burden (sum of polyp size), compared to a 4.9 percent reduction in the placebo group.

"This study confirms that Celebrex has applications beyond arthritis and provides an important new treatment option for patients with FAP," said Dr. Philip Needleman, chief scientific officer, Pharmacia Corporation and the discoverer of Celebrex.

Current studies include the use of Celebrex in patients with sporadic adenomatous polyps (SAP) of the colon, Barrett's esophagus (a precursor to esophageal cancer), actinic keratosis (a precursor to skin cancer) and superficial bladder cancer.


© 2015 The University of Texas MD Anderson Cancer Center