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One-Third of Patients Discontinue Common Breast Cancer Therapy

itrate) is now available in U.S. pharmacies nationwide. SOLTAMOX is the only liquid form of the hormonal breast cancer therapy, tamoxifen, approved by the FDA and available in the U.S. SOLTAMOX is indicated for the treatment of metastatic breast cancer, adjuvant treatment of breast cancer, ductal carcinoma in situ (DCIS), and reduction in breast cancer incidence in high risk women.

WARNING - For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism.

Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women).

Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women years of 0.17 for tamoxifen vs. 0.0 for placebo) *. For stroke, the incidence rate per 1,000 women years was 1.43 for tamoxifen vs. 1.00 for placebo**.

For pulmonary embolism, the incidence rate per 1,000 women years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal.

Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

Full prescribing information for SOLTAMOX is available on Cytogen's Web site at http://www.cytogen.com.

(1) Barron, Thomas I., Roisin Connolly, Bennett Kathleen, John Feely, and M. John Kennedy. "Early Discon
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