FDA Presents: Tamoxifen & Uterine Sarcoma

Ann's NOTE: This information applies to healthy women at 'high'risk of breast cancer, as well as those with DCIS!

During the recent meeting of the American Society of Clinical Oncology (ASCO), the FDA presented new information on an association between use of tamoxifen and subsequent development of uterine sarcoma.

Uterine Sarcoma, as defined by The Cancer Dictionary, is an extremely rare type of Endometrial Cancer. It accounts for between 1 and 5% of all endometrial (uterine) cancers. Symptoms include bleeding after menopause or bleeding that is not part of menstruation.

Information collected by the U.S. Food and Drug Administration indicates that women who have used tamoxifen for breast cancer treatment or prevention have an increased risk of developing uterine sarcoma.

Review of all the NSABP clinical trials using tamoxifen confirmed an increased risk of this rare cancer.

In the Breast Cancer Prevention Trial, there are about 2 cases per 10,000 women taking tamoxifen each year. Research to date indicates that uterine sarcomas are more likely to be diagnosed at later stages than endometrial cancers, and may therefore be harder to control and more life-threatening than endometrial cancer.

Subsequently, the CIS is contacting your organization to inform you and your constituents of this new information. Also, as it is the CIS mission to provide the most up-to-date and accurate cancer information, several Cancer Facts Sheets have been updated to reflect this new information. Cancer Facts Sheets that have been changed are listed:

- Chemoprevention - http://cis.nci.nih.gov/fact/4_2.htm

- Tamoxifen: Questions and Answers - (English and Spanish versions)

English version - http://cis.nci.nih.gov/fact/7_16.htm Spanish version - http://cis.nci.nih.gov/fact/7_16s.htm

- The Study of Tamoxifen and Raloxifene (STAR): Questions and Answers - (English and Spanish versions)

English version - http://cis.nci.nih.gov/fact/4_19.htm Spanish version - http://cis.nci.nih.gov/fact/4_19s.htm

- Adjuvant Therapy for Breast Cancer: Questions and Answers (English and Spanish versions)

English version - http://cis.nci.nih.gov/fact/7_20.htm Spanish version - http://cis.nci.nih.gov/fact/7_20s.htm

- Breast Cancer Prevention Studies - http://cis.nci.nih.gov/fact/4_18.htm

All NCI Fact sheets can be obtain by visiting www.cancer.gov or calling the Cancer Information Service at 1-800-4-CANCER telephone number.


Uterine Sarcoma Risk

New York Times, 6/28/02

Advocate Letter to FDA on Warning Labels, 2002

Helen Schiff, NYC-based advocate

Risk Maliganant Mixed Mullerian Tumors *(Uterine)

JNCI, 1/04


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