Would you like a chance to see if a new experimental treatment can reduce your risk of
- A new polyp in your colon?
- Colon cancer spreading beyond your colon?
- A new colon cancer?
Researchers at the National Surgical Adjuvant Breast and Bowel Project (NSABP) would like to talk to you about a clinical trial exploring whether a statin drug can reduce the risk of new polyps, colon cancer recurrence, or a new primary colon cancer.
In the P-5 clinical trial stage I and II colon cancer patients will be randomly assigned to take either rosuvastatin (Crestor®) or an inert placebo for five years.
What’s the thinking behind the P-5 trial?
Studies of statins and colorectal cancer risk are controversial and some conflict.
However, a study that looked back at colon cancer patients in Israel and matched them to similar people who didn’t have colon cancer found that a larger percentage of patients who didn’t have colon cancer had taken statins for more than 5 years. About half as many colon cancer patients had taken statins (6.1 percent) as people who didn’t have cancer (11.6 percent). Even after adjusting for other risk factors for colorectal cancer, including taking aspirin regularly, statin use reduced colon cancer risk by about 45 percent.
In addition, scientists looking at cell processes have found that statins block a protein that is important in cell growth. Blocking its action may prevent colon cancer from spreading or polyps from developing.
Who can be part of the trial?
Stage I and II colon cancer patients who
- have finished their planned treatment — surgery or adjuvant chemotherapy.
- are no more than 1 year past their treatment.
- have had a complete colonoscopy in the past six months and all polyps removed.
- if they are taking aspirin regularly agree to continue it during the five years of the trial.
- have not taken a statin within a month of entering the trial.
Are there colon cancer patients who are excluded from P-5?
- Patients who are regularly taking NSAIDS, except for aspirin.
- Patients with familial adenomatous polyposis (FAP)
- Patients with Lynch syndrome (HNPCC or hereditary non-polyposis colon cancer)
- Have high cholesterol levels that might require them to take a statin.
Are you interested?
- Talk to your surgeon or oncologist about the NSABP P-5 clinical trial.
- Locate a P-5 trial site and contact near you.
Phase III Randomized Study of Adjuvant Rosuvastatin in Patients With Resected Stage I or II Colon Cancer
- Arm I: Patients receive oral rosuvastatin once a day for five years.
- Arm II: Patients receive an oral placebo once a day for five years.
Patients on the trial will have physical exams every six months, a colonoscopy within 6 months of starting the trial, and colonoscopies 1, 3, and 5 years to look for new polyps.
The study is double-blinded — neither patients nor their doctors will know if they are getting rosuvastatin or a placebo.
Some study patients will also be asked about their quality of life and tissue samples will be analyzed for biomarkers.
Writing in the NCI Cancer Bulletin, NSABP Protocol Chair for P-5, Dr. Bruce Boman said,
While some retrospective observational studies suggest that statins prevent colorectal cancer, others do not. Moreover, most of these studies were short term and were not designed to look at tumor development; so the jury is still out on the efficacy of statins. What is needed is a properly designed, long-term, prospective study that evaluates tumor development, and that’s why the randomized, placebo-controlled, double-blind NSABP-P-5 study was developed.