PITTSBURGH – A clinical trial underway at Allegheny General Hospital (AGH) is exploring whether statin drugs, prescribed for millions of Americans to lower their cholesterol levels, may also protect against a colon cancer or colonic polyp recurrence.
Launched by AGH in conjunction with the Pittsburgh-based National Surgical Adjuvant Breast and Bowel Project (NSABP), the new clinical trial – known as NSABP P-5 – is the first long-term, prospective, randomized, placebo-controlled, double-blind study to determine the effectiveness of statins for prevention of colon cancer. Previous retrospective, observational studies reached varying conclusions about statins’ preventative effect on cancer.
NSABP P-5 is a national study that is open to enrollment in the Pittsburgh region at WPAHS’ AGH, West Penn Hospital, and Forbes Regional Hospital.
The trial will examine the effect of aspirin on colon cancer recurrence. A recent study published in the Lancet found people who took a daily aspirin for three years reduced their risk of developing cancer by 25 percent. After five years, the risk dropped by 37 percent.
“As physicians, we would rather prevent cancer than treat it,” said Thomas B. Julian, MD, Director of Breast Surgical Oncology at AGH and Senior Surgical Director of Medical Affairs at NSABP. “We expect this clinical trial to provide us with very useful information on how statins might work as a cancer preventative, alone or when combined with aspirin.”
“We know that aspirin has some benefit in preventing colorectal polyps and cancer,” Dr. Julian continued. “We hope to find out through this trial whether statins and aspirin combined will boost each other’s power to prevent cancer.”
The trial is open to patients diagnosed with stage I or II colon cancer who have undergone surgery to remove their primary tumor. They will be studied in three categories: those with a family history of colon cancer, those who take aspirin (including different doses) and those who have had adjuvant therapy such as chemotherapy as part of their colon cancer treatment.
Study participants will be randomly assigned to take either rosuvastatin (Crestor) or a placebo daily for five years. They will have regular physical exams and colonoscopies so that doctors can check for the development of a new tumor or appearance of a second primary cancer.
Surgery alone cures about half of the people diagnosed with colon cancer, but about half go on to develop a second tumor, either an adenomatous polyp that can become cancerous if not removed, or a second primary cancer, known as a metachronous cancer.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) is a clinical trials cooperative group supported since its inception by the National Cancer Institute (NCI). With its Operation Center based on the AGH campus, the NSABP has conducted clinical trials for more than 50 years and has helped change the way breast and bowel cancer is treated, and, more recently, prevented. NSABP breast cancer studies led to the establishment of lumpectomy plus radiation over radical mastectomy as the standard surgical treatment for breast cancer, and the NSABP was the first to demonstrate on a large scale the preventive effects of the drugs tamoxifen and raloxifene in breast cancer.
Those interested in finding out more about the NSABP P-5 clinical trial at AGH can call 412.359.6464.
Information online is available at http://www.ClinicalTrials.gov or http://www.NSABP.pitt.edu/