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Evidence-Based Medicine 2006;11:177; doi:10.1136/ebm.11.6.177
Copyright © 2006 by the BMJ Publishing Group Ltd.

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Therapeutics

Raloxifene and tamoxifen had similar efficacy for preventing invasive breast cancer in women at increased risk

Vogel VG, Costantino JP, Wickerham DL, et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 2006;295:2727–41.[Abstract/Free Full Text]

Q In postmenopausal women at increased risk, what is the comparative efficacy and safety of raloxifene and tamoxifen for preventing invasive breast cancer?

Clinical impact ratings GP/FP/Primary care ******{star} Oncology ******{star} Endocrine *****{star}{star}

Key Words: breast neoplasms • raloxifene • selective oestrogen receptor modulators • tamoxifen

The first 150 words of the full text of this article appear below.

METHODS
Formula Design: randomised controlled trial.

Formula Allocation: concealed.*

Formula Blinding: blinded (clinicians, participants, and outcome assessors).*

Formula Follow up period: mean 3.9 years.

Formula Setting: nearly 200 clinical centres in North America.

Formula Participants: 19 747 postmenopausal women >=35 years of age (mean age 59 y) whose 5 year predicted risk of breast cancer was >=1.66% (mean 4.03%) based on the Gail model. Exclusion criteria included recent hormone therapy use; stroke or venous thromboembolism (VTE) history; cancer in the previous 5 years; and uncontrolled atrial fibrillation, diabetes, or hypertension.

Formula Intervention: raloxifene, 60 mg/day (n = 9875), or tamoxifen, 20 mg/day (n = 9872), for a maximum 5 years.

Formula Outcomes: invasive breast cancer, non-invasive breast cancer, uterine cancer, uterine hyperplasia, ischaemic heart disease, stroke, VTE, osteoporotic fractures, cataracts, and death.

Formula Patient follow up: 99% (intention to treat analysis).

MAIN RESULTS
The tableGo shows the results for significant differences. Groups did not differ for invasive or non-invasive breast cancer, ischaemic . . . [Full text of this article]

Vered Stearns, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,
Baltimore, Maryland, USA


Relevant Article

Glossary
Evid. Based Med. 2006 11: 191. (in Glossary) [Extract] [Full Text] [PDF]






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