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.
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Soltamox (Tamoxifen)
Tamoxifen: Risk of Rare Second Breast Cancer?
Source: MedicineNet Uterine Cancer Specialty [2009.08.26]
Title: Tamoxifen: Risk of Rare Second Breast Cancer?
Category: Health News
Created: 8/26/2009
Last Editorial Review: 8/26/2009
Femara vs. Tamoxifen for Breast Cancer
Source: MedicineNet Breast Cancer Questions To Ask The Doctor Specialty [2009.08.20]
Title: Femara vs. Tamoxifen for Breast Cancer
Category: Health News
Created: 8/20/2009
Last Editorial Review: 8/20/2009
Some Antidepressants May Thwart Tamoxifen's Effect on Breast Cancer
Source: MedicineNet letrozole Specialty [2009.06.01]
Title: Some Antidepressants May Thwart Tamoxifen's Effect on Breast Cancer
Category: Health News
Created: 6/1/2009 7:00:00 AM
Last Editorial Review: 6/1/2009
Tamoxifen for breast cancer prevention of little benefit
Source: The Doctors Lounge - Oncology
Only women at very high risk for breast cancer experience a benefit according to a study published in the journal Cancer.
Cost Of Noncompliance Revealed By Study Of Adjuvant Endocrine Treatment For Breast Cancer
Source: Compliance News From Medical News Today [2009.09.23]
The largest study in the world of treatments for post menopausal, hormone positive breast cancer has shown that patients who continue to take exemestane or tamoxifen do significantly better than patients who start to take one or other drug (or tamoxifen followed exemestane) but then stop.
Published Studies Related to Soltamox (Tamoxifen)
Prevention of tamoxifen induced endometrial polyps using a levonorgestrel releasing intrauterine system long-term follow-up of a randomised control trial. [2009.09]
OBJECTIVES: In a RCT, we have previously shown that the levonorgestrel intrauterine system (LNG-IUS, Mirena) produces a decidual response protecting the endometrium at one year follow-up. We here report on the long-term follow-up of this group of women, to test the hypothesis that a LNG-IUS could prevent the pro-proliferative uterine responses of tamoxifen for up to 4.5 years... CONCLUSION: This study confirms that LNG-IUS induces benign endometrial changes and prevents endometrial polyps but only during its use in women taking tamoxifen. Endometrial thickness is a risk factor for the development of polyps.
Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study. [2009.08.18]
BACKGROUND: It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer... CONCLUSION: UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.
Randomized double-blind 2 x 2 trial of low-dose tamoxifen and fenretinide for breast cancer prevention in high-risk premenopausal women. [2009.08.10]
PURPOSE: Tamoxifen and fenretinide are active in reducing premenopausal breast cancer risk and work synergistically in preclinical models. The authors assessed their combination in a two-by-two biomarker trial... CONCLUSION: Despite favorable effects on plasma IGF-I levels and mammographic density, the combination of low-dose tamoxifen plus fenretinide did not reduce breast neoplastic events compared to placebo, whereas both single agents, particularly fenretinide, showed numerical reduction in annual odds of breast neoplasms. Further follow-up is indicated.
A randomized placebo-controlled study of tamoxifen after adjuvant chemotherapy in premenopausal women with early breast cancer (National Cancer Institute of Canada--Clinical Trials Group Trial, MA.12). [2009.07.23]
BACKGROUND: In the early 1990s, the role of adjuvant tamoxifen in premenopausal women with early breast cancer (EBC) was not established. Similarly, optimum timing relative to adjuvant chemotherapy and efficacy of tamoxifen in hormone receptor-negative tumors were unclear... CONCLUSIONS: Adjuvant tamoxifen, given after chemotherapy to premenopausal women with EBC, improved 5-year DFS. Poor compliance may have reduced treatment efficacy.
Endocrine effects of adjuvant letrozole compared with tamoxifen in hormone-responsive postmenopausal patients with early breast cancer: the HOBOE trial. [2009.07.01]
PURPOSE We compared the endocrine effects of 6 and 12 months of adjuvant letrozole versus tamoxifen in postmenopausal patients with hormone-responsive early breast cancer within an ongoing phase III trial. PATIENTS AND METHODS Patients were randomly assigned to receive tamoxifen, letrozole, or letrozole plus zoledronic acid...
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]
The purpose of this study was to assess the difference in disease-free survival between
post-menopausal women with hormone receptor-positive early breast cancer who switched from
tamoxifen to anastrozole and those who continued on tamoxifen.
Phase II Metastatic ER+/PgR+ Nolvadex +/- Iressa Study [Completed]
This study is being carried out to see if ZD1839 is effective in treating metastatic breast
cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.
Casodex - Nolvadex Combination [Completed]
This study looks at the relationship in the dose of nolvadex and the incidence of
gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with
Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the
breast tissue adverse effects without reducing the efficacy of Casodex.
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women. [Active, not recruiting]
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment
with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment
with tamoxifen in postmenopausal women with early breast cancer
Randomized Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-Positive Patients [Completed]
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide
vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with
potentially curative, operated hormone receptor-positive breast cancer.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Soltamox has an overall score of 7.50. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Soltamox review by 60 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | atypical hyperplasia in breast and hypothyrodism |
| Dosage & duration: | | levothyroxine 50mcg tamoxifen ? (dosage frequency: once per day) for the period of life and 5 yers |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The tamoxifen has kept my condition (benign) constant and with no signs of maligancy developing for ten years since the discovery of the condition. Levothyroxine raised my levels to normal and I am less fatigued and feeling generally healthy. |
| Side effects: | | There were not side effects |
| Comments: | | I took tamoxifen for 5 years on a daily basis and continue to have biannual checkups.
Levothyroxine stared with a 25mcg dosage. A follow up blood work showed the dosage had to be raised to 50 mcg and is what I am now taking. |
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| | Soltamox review by 58 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | breast cancer |
| Dosage & duration: | | 20 mg taken daily for the period of 4 years |
| Other conditions: | | none |
| Other drugs taken: | | none post chemotherapy | | |
Reported Results |
| Benefits: | | A non return of breast cancer |
| Side effects: | | night sweats
polyps in the womb
brought about the menopause
weight gain |
| Comments: | | I had a mastectomy and radio therapy followed by 6 months of chemotherapy and then tamoxifen. Weight gain and ceasing mensturation may have been caused byt he combined effects of the chemotherapyt and tamoxifen.
Given I had 3 polyps removed it was decided to cease tamoxifen in the 5th year. |
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Page last updated: 2009-10-20
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