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Soltamox (Tamoxifen Citrate) - Summary

 

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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.

* Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma. ** See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies.

 

SOLTAMOX SUMMARY

WARNING

SOLTAMOX™ solution, a nonsteroidal antiestrogen, is for oral administration. Each 5 mL solution contains 15.2 mg tamoxifen citrate, equivalent to 10 mg tamoxifen.

Tamoxifen citrate is indicated for the following:

Metastatic Breast Cancer

Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate therapy.

Adjuvant Treatment of Breast Cancer

Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.

Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.

The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial.

Tamoxifen citrate reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer.

Ductal Carcinoma in Situ (DCIS)

In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the label). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy.

Current data from clinical trials support five years of adjuvant tamoxifen citrate therapy for patients with breast cancer.

Reduction in Breast Cancer Incidence in High Risk Women

Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. This effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. Twenty-five percent of the participants received drug for 5 years. The longer term effects are not known. In this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see BOXED WARNING at the beginning of the label).

Tamoxifen citrate is indicated only for high-risk women. "High risk" is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model.

SOLTAMOX NEWS HIGHLIGHTS

Media Articles Related to Soltamox (Tamoxifen)

New Molecule Discovery Shows Promise Against Tamoxifen-Resistant Breast Cancers
Source: MedicineNet tamoxifen Specialty [2008.06.17]

Tamoxifen for breast cancer prevention of little benefit
Source: The Doctors Lounge - Oncology

Joint Symptoms More Likely For Some Breast Cancer Patients
Source: Endocrinology News From Medical News Today [2008.08.15]

more>>

Published Studies Related to Soltamox (Tamoxifen)

Meta-analysis of trials comparing anastrozole and tamoxifen for adjuvant treatment of postmenopausal women with early breast cancer. [2008.07.29]

Serum TIMP-1 and response to the aromatase inhibitor letrozole versus tamoxifen in metastatic breast cancer. [2008.06.01]

Histopathological assessment of anastrozole and tamoxifen as preoperative (neoadjuvant) treatment in postmenopausal Japanese women with hormone receptor-positive breast cancer in the PROACT trial. [2008.06]

HER2 status in hormone receptor positive premenopausal primary breast cancer adds prognostic, but not tamoxifen treatment predictive, information. [2008.05]

Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. [2008.04.20]

more>>

Clinical Trials Related to Soltamox (Tamoxifen)

ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years [Active, not recruiting]

Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study [Completed]

Casodex - Nolvadex Combination [Completed]

Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. [Active, not recruiting]

Randomized Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-Positive Patients [Completed]

more>>

Page last updated: 2008-08-15

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