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Related Pages |
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Uterine Sarcoma Home Page
NCI's gateway for information about uterine sarcoma.
Breast Cancer Home Page
NCI's gateway for information about breast cancer.
Highlights from ASCO 2002
A collection of links to material summarizing some of the important clinical trial results announced at the 2002 annual meeting of the American Society of Clinical Oncology (ASCO).
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Tamoxifen Poses Slightly Greater Risk of Uterine Sarcoma
Key Words: breast cancer, tamoxifen, uterine cancer. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)
It's been known that tamoxifen -- a commonly prescribed treatment and prevention drug for breast cancer -- increases the risk of endometrial cancer (cancer of the lining of the uterus). Now researchers with a large breast cancer study project and representatives from the U.S. Food and Drug Administration (FDA) report that tamoxifen also slightly raises the risk of uterine sarcoma, a rare cancer of the muscles or other supporting tissue of the uterus.
U.S regulations require drug manufacturers to report adverse drug reactions to the FDA. A recent analysis of the FDA's Adverse Events database showed an increased risk of uterine sarcoma for women taking tamoxifen. The National Surgical Adjuvant Breast and Bowel Project (NSABP) also analyzed its clinical trial data to evaluate the possible association between tamoxifen use and an increased risk of uterine cancer based on case-control studies from Europe published in 2000.
[Editor's note: These data were subsequently published in a letter to the New England Journal of Medicine and a letter to the Journal of Clinical Oncology.]
On Monday, May 13, 2002, the online version of the Journal of Clinical Oncology published a letter from the NSABP that analyzed uterine sarcoma risk in women using tamoxifen during the Project's 30-plus years of clinical trials. NSABP found that of 17,000 women taking tamoxifen as part of their research studies, 12 developed uterine sarcomas. NSABP estimates that the five-year incidence of uterine sarcoma in women taking tamoxifen is less than one-tenth of one percent.
The FDA presented its data on May 20, 2002, at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla., and has submitted a letter to a prominent medical journal for publication. In addition to the JCO letter, NSABP has sent out a letter to its members. AstraZeneca, the maker of tamoxifen, will also be sending out a letter the week of May 20 alerting more than 200,000 U.S. health professionals to the findings.
Estrogen promotes the growth of breast cancer cells. Tamoxifen works against the effects of estrogen on these cells. As a treatment for breast cancer, the drug slows or stops the growth of cancer cells that are present in the body. As adjuvant (after surgery) therapy, tamoxifen helps prevent the original breast cancer from returning and also helps prevent the development of new cancers in the other breast. Tamoxifen has been demonstrated to improve relapse-free and overall survival for women with hormone-receptor positive breast cancer.
The prognosis for women with uterine sarcoma or endometrial cancer who had taken tamoxifen is no worse than for women not exposed to tamoxifen. Patients who are concerned about the risks and benefits of tamoxifen or any other medications are encouraged to discuss these concerns with their doctor. A tamoxifen fact sheet prepared by the National Cancer Institute's Cancer Information Service might also be helpful.
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