The Food and Drug Administration (FDA) recently
approved celecoxib (Celebrex) as an oral adjunct to the standard care
(eg, endoscopic surveillance and surgery) of patients with familial
adenomatous polyposis (FAP). Celecoxib, the only cyclooxygenase-2
(COX-2) specific inhibitor indicated for the treatment of both
osteoarthritis and adult rheumatoid arthritis, is the first
pharmacologic agent to be indicated to reduce the number of
adenomatous colorectal polyps in patients with FAP.
We are committed to fulfilling unmet medical needs for people
who must live day to day with this severe and life-altering disease.
The National Cancer Institutes sponsorship of the FAP clinical
study underscores the importance of medical research into the needs
of patient populations with devastating conditions, said Philip
Needleman, PhD, co-president, Searle, and chief scientist, Monsanto,
who discovered Celebrex. We are just beginning to unlock the
potential of Celebrex beyond arthritis.
Important Additional Treatment Option
Familial adenomatous polyposis is characterized by the development of
hundreds to thousands of potentially precancerous (adenomatous)
polyps in the colon and rectum. Many of these polyps express high
levels of COX-2, compared to normal adjacent tissue, and may be
precursor lesions for colorectal cancer. Left untreated, virtually
all patients with FAP develop colorectal cancer by age 40 to 50
years, and to date, no drugs have been approved for the care of
patients with FAP.
A 6-month, 83-patient clinical trial, sponsored by the National
Cancer Institutes Division of Cancer Prevention in
collaboration with Searle, is the largest randomized, double-blind,
placebo-controlled trial to date in FAP. The study demonstrated that
an oral, 400-mg dose of celecoxib twice daily significantly reduced
the number of adenomatous colorectal polyps by an average of
28%compared to a 5% reduction with placebo. The study was
conducted at the University of Texas, M. D. Anderson Cancer Center in
Houston, as well as at St. Marks Hospital in London.
This is the first real breakthrough in our ability to offer FAP
patients a proven adjunctive therapy to usual care, said Gideon
Steinbach, MD, one of the studys lead investigators and
assistant professor of medicine, the University of Texas, M. D.
Anderson Cancer Center.
FAP is a life-threatening disease that urgently requires new
treatment options in addition to what is now available. We believe
that the FDAs approval of Celebrex represents an important step
forward in bringing hope and state-of-the-art care to people with
FAP, said Carolyn Aldige, president and founder, Cancer
Research Foundation of America.
In the FAP trial, common side effects of celecoxib were diarrhea and
dyspepsia. Celecoxib has not been shown to reduce the risk of
gastrointestinal (GI) cancer or the need for any FAP-related
surgeries. Therefore, usual endoscopic surveillance and surgery
schedules should not be altered in patients treated with the drug.
Future Trials to Assess Drugs Effect on Cancer Development
Since the current trial did not include a cancer end point, the
effect of celecoxib on the development of cancer has not yet been
established. Searle and Pfizer will be conducting further studies to
assess the clinical benefit of celecoxib in this regard. Searle and
Pfizer are also conducting research, in collaboration with the
National Cancer Institute, into the use of celecoxib in patients with
sporadic adenomatous polyps (SAP) of the colon, Barretts
esophagus, actinic keratosis, and superficial bladder cancer.