Studying statin chemoprevention in colon cancer patients

Anupama Kurup, M.D.
Medical director, Providence Cancer Survivor Program
Medical oncologist, Providence Oncology and Hematology Care Clinic-Westside

Published July 2011

Epidemiological studies of colorectal cancer development have indicated that statin drugs, or HMG-CoA reductase inhibitors, can be chemopreventive agents.

Besides the drugs’ effectiveness as lipid-lowering agents, preclinical data have shown that some statins trigger apoptosis in various tumor cell types. There is evidence that they exert anti-inflammatory and anti-oxidative actions, and can induce tumor suppressors in colorectal cancer.

Less is known about the effect of these agents in high-risk subgroups, such as patients with resected colon cancer; and the effectiveness of statins as chemopreventive agents remains to be established by prospective randomized trials.

Patients can now be enrolled in NSABP P5, a phase 3 randomized, placebo-controlled study that seeks to determine the effect of rosuvastatin in five-year occurrence of adenomatous polyps, metachronous colorectal carcinoma and colon cancer recurrence in patients with resected stage I or II colon cancer.

The study will stratify patients by possible influential subsets: first-degree family history, aspirin use and adjuvant chemotherapy.

Enrolled patients are randomized to receive rosuvastatin 10 mg or placebo orally once daily for five years. All stage I or II colon cancer patients are eligible if surgical resection was completed within one year of study randomization. Adjuvant therapy must be completed before randomization. Low-dose aspirin use is allowed as long as the patient is willing to continue at the same dose during the study. Otherwise, chronic NSAIDs use is prohibited while the patient is on study therapy.

The chemoprevention strategy (for example, five years of oral tamoxifen) has been effective and widely used in women for prevention of breast disease, such as ductal carcinoma in situ and invasive breast cancer. If NSABP P5 is successful, it will finally offer early-stage colon cancer patients a similar opportunity to reduce their risks.

The NSABP P5 trial is available by referral to oncologists at Providence Cancer Center and the investigator members of the Columbia River Oncology Program. This study has been endorsed by the National Cancer Institute Community Cancer Centers Program.

Clinical articles by Anupama Kurup, M.D.