Dr. Nate Link on the STAR-2 trial October 24, 2006
Posted by rajkmd in Primary Care, Women's Health.trackback
- This comment is in relation to the following trial:
- The STAR P-2 trial is the most recent of several studies assessing the impact of SERMS on breast cancer. In the NSABP P-1 trial (NCI 1998;90:1371), tamoxifen prevented about 4 cases of breast cancer per 1000 high risk women treated per year (a 50% relative risk reduction!) but caused modest increases in thromboembolism, stroke, and endometrial cancer. In the MORE trial (JAMA 1999;282:637) raloxifene prevented 4 breast cancers and 6 vertebral fractures per 1000 women per year but also caused increases in thromboembolism and stroke. The STAR P-2 trial was the first to compare these two drugs head to head.Based on all three trials we would expect either raloxifene or tamoxifen to reduce the incidence of invasive breast cancer by 50%, but all the prevented cancers will be estrogen receptor positive, the tumors that are the easiest to treat and cure anyway. The studies were not large enough or long enough to determine whether breast cancer mortality will be affected by the SERMS. The scorecard: for every 1000 women at high risk for breast cancer who take raloxifene for one year, one can expect treatment to prevent 4 cases of invasive breast cancer and 6 cases of vertebral fracture, and to cause 1 stroke and 2 cases of thromboembolism. Mortality is unlikely to be affected in the short-term. Tamoxifen appears to be somewhat more likely to cause thromboembolism and uterine cancer – probably about 1 case per 1000 of each – and less likely to prevent fractures. Overall, raloxifene appears to have an edge in benefits versus risks.
- Despite the favorable publicity surrounding these results, the nuances of the data and modest increases in serious outcomes such as stroke and thromboembolism preclude a simple recommendation for use of SERMS. The higher the baseline risk of breast cancer, the more favorable will be the benefit/risk ratio, but patient preference clearly needs to be a part of this decision.
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