1] However, their polyp contained an area of tubular and villous adenomatous
glands with a single focus of high-grade dysplasia.
People with FAP develop hundreds or thousands of chronic adenomatous
polyps, beginning at about age 16.
Individuals who had undergone colonoscopy, sigmoidoscopy or double contrast barium enema within the preceding 10 years or a positive fecal occult blood test within six months were excluded, as were those with inflammatory bowel disease, familial adenomatous
polyposis or hereditary non-polyposis colon cancer, more than one first degree relative with colorectal cancer, or any first degree relative with colorectal cancer before age 50.
Subjects were excluded for the following reasons: positive guaiac test within 6 months; iron-deficiency anemia within 6 months; rectal bleeding or hematochezia within 12 months; unintentional weight loss of more than 10 pounds within 12 months; optical colonoscopy in previous 10 years; barium enema in previous 5 years; history of adenomatous
polyps, colorectal cancer, or inflammatory bowel disease; history of familial adenomatous
polyposis or hereditary nonpolyposis cancer syndromes; rejection for optical colonoscopy for any reason; medical condition that precluded the use of sodium phosphate preparation; pregnancy.
Persons who carry the gene for familial adenomatous
polyposis and those who are at risk for it should be screened annually with sigmoidoscopy beginning at age 10-12 years.
The clinical study demonstrated that an oral dose of Celebrex 400 mg twice a day significantly reduced the number of adenomatous
colorectal polyps by an average of 28 percent -- compared to a 5 percent reduction with placebo.
Of these, 344 were 6 mm or larger, and 210 of them were adenomatous
Clinical data presented today to ODAC indicated that Celebrex, at an oral dose of 400 mg twice a day, led to the reduction and regression of adenomatous
colorectal polyps in patients with FAP.
NYSE: PFE) announced today that a New Drug Application (NDA) for Celebrex (celecoxib capsules) has received a priority review designation from the Food and Drug Administration (FDA) for a new indication -- the regression and prevention of colorectal adenomatous
polyps in patients with familial adenomatous
Surveillance using colonoscopy should begin at age 40 in patients with a first-degree relative who developed colorectal cancer before age 55 and in those with a first-degree relative who developed adenomatous
polyps before age 60.
APC is characterized by the development of hundreds to thousands of adenomatous
polyps in the colon that, if left untreated, will invariably progress to colon cancer.
Cell Pathways had initiated the current Phase III trial based upon pre-clinical data in orthotopic rat models and the combined safety database of successive clinical programs that had originally focused on the pre-cancerous condition familial adenomatous