Clinical Trial Reports

by Stanton R. Mehr
Published: Wednesday, Jun 16, 2010
Click here to view as PDF.

PHASE IV

Long-Term Aspirin Therapy Reduces Colorectal Cancer Risk


Much has been hinted at the possible benefit of nonsteroidal anti-inflammatory use to prevent colorectal cancer. A long-term, large prospective, nonrandomized study performed by researchers at Harvard Medical School, Boston, finally answers this question, and it seems that the protective effect may well be dose related.

The clinicians gathered data on aspirin use, risk factors, and diagnoses of colorectal cancer in 47,363 male health professionals who, when enrolled in 1986, were 40 to 75 years of age. Data on aspirin use were collected every two years.

The investigators documented 975 cases of colorectal cancer over 761,757 person-years, during the 18 years of follow-up. After risk-factor adjustment, the researchers found that individuals who used aspirin regularly (≥ 2 times/wk) experienced a multivariate relative risk (RR) for colorectal cancer of 0.79 (95% confidence interval [CI], 0.69–0.90) compared with those who did not use aspirin regularly. This difference was not deemed statistically significant. However, study participants who used aspirin regularly for six to 10 years did have a significant risk reduction (P = 0.008). Within four years of discontinuing use, this benefit was no longer evident (multivariate RR, 1.00).

They found that the preventive benefit was correlated with increasing cumulative average dose: Compared with men who did not use aspirin (RR, 1.0), the multivariate RRs for cancer were 0.94 for men who used 0.5–1.5 standard (325-mg aspirin tablets per week, 0.80 for 2–5 tablets/wk, 0.72 for 6–14 aspirin tablets/wk, and 0.30 for > 14 tablets/wk (P for trend = 0.004).

The risk of colorectal cancer among men is reduced by regular, long-term aspirin use, the researchers noted, although the benefit of aspirin therapy requires at least six years of consistent use with the maximal risk reduction at doses more than 14 tablets/week. No advantage was seen by taking aspirin for less than five years or the equivalent of less than 1.5 tablets/week.

However beneficial the high dosage seems in terms of colorectal cancer prevention, the authors warn, high aspirin intake can result in serious gastrointestinal side effects.

Aspirin Benefit in Colorectal Cancer

 Aspirin Intake Risk Reduction
 No aspirin use 0%
 162–487 mg/wk 6%
 650–1,625 mg/wk 20%
 1,950–4,450 mg/wk 28%
 >4,450 mg/wk 70%



Chan AT, Giovannucci EL, Meyerhardt JA, et al: Aspirin dose and duration of use and risk of colorectal cancer in men. Gastroenterology 2008;134:341-343.






PHASE III

Does Adding Cisplatin to Adjuvant Chemotherapy Improve Outcomes in Advanced Gastric Cancer?


Previous studies have suggested that mitomycin-C plus fluoropyrimidine (Mf) may improve the outcome of curatively resected advanced gastric cancer, although a debate remains about the role of adjuvant chemotherapy. In a randomized phase III trial, researchers have extended the administration of oral fluoropyrimidine to improve the adjuvant Mf chemotherapy while adding cisplatin to the Mf regimen (MFP) in order to determine whether that strategy could improve three-year relapse-free survival for patients who had undergone resection for advanced gastric cancer.

The trial group consisted of patients who had postoperative stage II–IV three to six weeks after undergoing surgery. They were randomized to receive either Mf or MFP chemotherapy. Individuals in the Mf group received an injection of mitomycin C 20 mg/m² and four weeks later, doxifluridine 460–600 mg/m²/day orally for three months. For patients in the MFP group, doxifluridine was continued for a total of 12 months; six bolus injections of monthly cisplatin 60 mg/m² were added to Mf chemotherapy.


View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Key Questions for the Use of Immunotherapy Throughout the Disease Continuum for NSCLC in an Era of Rapid DevelopmentSep 29, 20181.5
Provider and Caregiver Connection™: Addressing Patient Concerns While Managing GlioblastomaSep 29, 20182.0
Publication Bottom Border
Border Publication
x