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Raloxifene and colorectal cancer
Judith M E Walsh1, Angela M Cheung, Donald Yang
1Division of General Internal Medicine, University of California, San Francisco, USA. jwalsh@medicine.ucsf.edu
Journal of Women'S Health (2002)
|May 27, 2005
Summary
Raloxifene did not show a significant effect on colorectal cancer (CRC) risk in the MORE trial. While the study was large, more research is needed to confirm raloxifene
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Raloxifene is a selective estrogen receptor modulator used for osteoporosis prevention.
- Colorectal cancer (CRC) is a significant health concern, and potential drug effects warrant investigation.
- The Multiple Outcomes of Raloxifene Evaluation (MORE) trial initially assessed raloxifene's impact on vertebral fractures.
Purpose of the Study:
- To evaluate the effect of raloxifene on the risk of developing colorectal cancer (CRC).
Main Methods:
- Analysis of data from the randomized, blinded MORE trial involving 7705 women.
- Follow-up period averaged 3.4 years, with CRC cases categorized by certainty (definite, probable, possible).
- Multivariate Cox proportional hazards models were used to calculate the relative hazard for CRC.
Main Results:
- Fifty CRC cases (29 in the raloxifene group, 21 in the placebo group) were diagnosed.
- The relative hazard for CRC with raloxifene was 0.78 (95% CI 0.43, 1.43), not statistically significant (p = 0.43).
- Analysis restricted to definite CRC yielded a similar non-significant relative hazard of 0.77 (95% CI 0.39, 1.5, p = 0.45).
Conclusions:
- The MORE trial, despite its size, had insufficient CRC cases for definitive conclusions on raloxifene's effect.
- No substantial increased risk of CRC was observed with raloxifene use.
- Further studies with larger cohorts and higher-risk populations are recommended to clarify raloxifene's impact on CRC risk.