Low-dose aspirin may prevent cancer in familial adenomatous polyposis patients: Study
Japan: Low-dose aspirin could be an alternate method for the prevention of colorectal cancer in familial adenomatous polyposis (FAP) patients, according to a recent study in the journal Lancet Gastroenterology & Hepatology.
The study found that the administration of low-dose aspirin safely suppressed the recurrence of colorectal polyps larger than 5·0 mm in FAP patients.
Colectomy is the only established treatment for the prevention of colorectal cancer in FAP patients. The procedure, however, greatly reduces the patient's quality of life. Thus, there is a need for an alternative method. In the trial, Prof Michihiro Mutoh, Kyoto Prefectural University of Medicine, Kyoto, Japan, and colleagues aimed to clarify the individual and joint effects of low-dose aspirin and mesalazine on the recurrence of colorectal polyps in Japanese patients with FAP.
For this purpose, the researchers performed a randomized, double-blind, placebo-controlled, multicentre trial with a two-by-two factorial design in 11 centers in Japan. It included patients aged 16–70 years with a history of more than 100 adenomatous polyps in the large intestine, without a history of colectomy. Before the study, patients underwent endoscopic removal of all colorectal polyps of at least 5·0 mm in diameter.
Patients were randomized to 4 groups -- aspirin (100 mg per day) plus mesalazine (2 g per day), aspirin (100 mg per day) plus mesalazine placebo, aspirin placebo plus mesalazine (2 g per day), or aspirin placebo plus mesalazine placebo. Treatment was continued until 1 week before the 8-month colonoscopy.
The primary endpoint was the incidence of colorectal polyps of at least 5·0 mm at 8 months and was assessed in the intention-to-treat population. Safety was assessed in the ITT population.
Between Sept 25, 2015, and March 13, 2017, 104 patients were randomly assigned to receive either aspirin or aspirin placebo (n=52) or mesalazine or mesalazine placebo (n=52). Two patients withdrew from the aspirin plus mesalazine placebo group.
Key findings of the study include:
- Two patients withdrew from the aspirin plus mesalazine placebo group.
- 26 (50%) of 52 patients who received no aspirin had colorectal polyps of at least 5·0 mm at 8 months, as did 15 (30%) of the 50 patients who received any aspirin, 21 (42%) of the 50 patients who received no mesalazine, and 20 (38%) of the 52 patients who received any mesalazine.
- The adjusted odds ratio for polyp recurrence was 0·37 in the patients who received any aspirin and 0·87 in any who received mesalazine.
- The most common adverse events were grade 1–2 upper gastrointestinal symptoms in three (12%) of 26 patients who received aspirin plus mesalazine, one (4%) of 24 patients who received aspirin plus mesalazine placebo, and one (4%) of 26 patients who received mesalazine plus aspirin placebo.
- There was one grade 4 event in the mesalazine plus aspirin placebo group, but not related to the treatment.
"Low-dose aspirin safely suppressed the recurrence of colorectal polyps larger than 5·0 mm in patients with FAP," wrote the authors. "These results suggest an effect of low-dose aspirin for FAP and could be an alternative method for preventing colorectal cancer in FAP."
The study titled, "Chemoprevention with low-dose aspirin, mesalazine, or both in patients with familial adenomatous polyposis without previous colectomy (J-FAPP Study IV): a multicentre, double-blind, randomised, two-by-two factorial design trial," is published in the journal Lancet Gastroenterology & Hepatology.