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
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)
10 Years of Tamoxifen Better Than 5: Study
Source: MedicineNet tamoxifen Specialty [2012.12.05]
Title: 10 Years of Tamoxifen Better Than 5: Study
Category: Health News
Created: 12/5/2012 10:35:00 AM
Last Editorial Review: 12/5/2012 12:00:00 AM
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.
Published Studies Related to Soltamox (Tamoxifen)
Weight change associated with anastrozole and tamoxifen treatment in
postmenopausal women with or at high risk of developing breast cancer. [2012]
Weight gain is commonly reported by breast cancer patients on tamoxifen or
aromatase inhibitors. Since weight gain may impact on outcome and compliance we
have prospectively assessed the effects of these agents on weight change in three
randomised trials for the treatment or prevention of breast cancer...
CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast
cancer patients. [2012]
for patient benefit from tamoxifen therapy... CONCLUSION: The results do not support the hypothesis that CYP2D6 genotype
Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for
premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. [2012]
goserelin for early breast cancer in the neoadjuvant setting... INTERPRETATION: Given its favourable risk-benefit profile, the combination of
Longer-term outcomes of letrozole versus placebo after 5 years of tamoxifen in
the NCIC CTG MA.17 trial: analyses adjusting for treatment crossover. [2012]
crossed over to letrozole after being unblinded... CONCLUSION: Exploratory analyses based on longer follow-up and adjusting for
Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial. [2011.11]
OBJECTIVE: To reevaluate the efficacy of induction of ovulation with CC versus TMX in a group of anovulatory subfertile women with PCOS in a randomized controlled trial... CONCLUSIONS: Clomiphene citrate is more successful than tamoxifen as a first line therapy for ovulation induction in women with PCOS. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
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.
Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg on the Pharmacokinetics of Tamoxifen When Coadministered to Healthy Post-menopausal Female Subjects [Recruiting]
The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on
the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy
post-menopausal female subjects. This study will also evaluate the safety and tolerability
of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female
subjects.
Tamoxifen Pharmacogenetics in Asian Breast Cancer Women [Recruiting]
PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM) [Recruiting]
All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of
potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of
tamoxifen treatment. However CYP2D6 polymorphisms and/or the use of CYP2D6 inhibitors as
co-medication may influence the treatment outcome of tamoxifen.
The investigators propose a prospective study in women taking tamoxifen at a dose of 20mg
QD. In each woman, information will be collected on endoxifen levels, CYP2D6 status,
adherence and use of co-medication. In women who are phenotypically poor metabolizers of
tamoxifen, a dose increase to 40mg QD will be applied and the effect of this intervention on
tamoxifen pharmacokinetics will be evaluated after 4 weeks.
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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: 2013-02-10
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