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Replaces Committee Opinion NumberJune Reaffirmed Committee on Gynecologic Practice This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Tamoxifen, a nonsteroidal antiestrogen agent, is widely used as adjunctive therapy for women with breast cancer, and it has been approved by the U.
Food and Drug Administration for adjuvant Achat Tamoxifen of breast cancer, treatment of metastatic breast cancer, and reduction in breast cancer incidence in high-risk women.
Tamoxifen use may be extended to 10 years based on new data demonstrating additional benefit. Women taking tamoxifen should be informed about the risks of endometrial proliferation, endometrial hyperplasia, endometrial cancer, and uterine sarcomas, and any abnormal vaginal bleeding, bloody vaginal discharge, staining, Achat Tamoxifen, or spotting should be investigated.
Postmenopausal women taking tamoxifen should be closely monitored for symptoms of endometrial hyperplasia or cancer, Achat Tamoxifen. Premenopausal women treated with tamoxifen have no known increased risk of uterine cancer and require no additional monitoring beyond routine gynecologic care. Achat Tamoxifen the patient has been identified to be at high risk of endometrial cancer, routine endometrial surveillance has not proved to be effective in increasing the early detection of endometrial cancer in women using tamoxifen and is not recommended.
If atypical endometrial hyperplasia develops, appropriate gynecologic management should be instituted, and the use of tamoxifen should be reassessed. Opinion Tamoxifen, a nonsteroidal antiestrogen agent, is widely used as adjunctive therapy for women with breast cancer. It has been approved by the U. Food and Drug Administration for the following indications: Adjuvant treatment of breast cancer Treatment of metastatic breast cancer Reduction in breast cancer incidence Achat Tamoxifen high-risk women Because obstetrician—gynecologists frequently treat women with breast cancer and women at risk of the disease, they may be Achat Tamoxifen for advice on the proper follow-up of women receiving tamoxifen.
The purpose of this Committee Opinion is to review the risk and to recommend care to prevent and detect uterine cancer in women receiving tamoxifen. Tamoxifen is one of a class of agents known as selective estrogen receptor modulators SERMs. Although the primary therapeutic effect of tamoxifen is derived from its antiestrogenic properties, this agent also has modest estrogenic activity.
In standard dosages, tamoxifen may be associated with endometrial proliferation, hyperplasia, polyp formation, invasive carcinoma, and uterine sarcoma, Achat Tamoxifen.
Most studies Achat Tamoxifen found that the increased relative risk of developing endometrial cancer for women taking tamoxifen is two to three times higher than that of an age-matched population 1—3.
The level of risk of endometrial cancer in women treated with tamoxifen is dose and time dependent, Achat Tamoxifen. Continuation of tamoxifen therapy for 10 years further reduced the risk of breast cancer recurrence and mortality 6. In an update of all National Surgical Adjuvant Breast and Bowel Project trials of patients with breast cancer, the rate of endometrial cancer was 1.
In a review of all National Surgical Adjuvant Breast and Bowel Project breast cancer treatment trials, the rate of sarcoma in women treated with tamoxifen was 17 perpatient years versus none in the placebo group 7.
Similarly, Achat Tamoxifen, in a separate trial of high-risk women without breast cancer taking tamoxifen as part of a breast cancer prevention trial with a median follow-up of 6.
This is compared with the incidence of one to two perpatient years in the general population 9. The National Surgical Adjuvant Breast and Bowel Project data Achat Tamoxifen difficult to interpret because of the rarity of uterine sarcomas and the fact that the effect of tamoxifen use on the rate of uterine sarcomas was not one of the primary or secondary endpoints in the original reports.
The National Surgical Adjuvant Breast and Bowel Project prevention trial Achat Tamoxifen data suggest that the risk of both invasive and noninvasive breast cancer is markedly reduced with tamoxifen prophylaxis. In this trial, however, the risk ratio for developing endometrial cancer was 2.
In addition, the ability of tamoxifen to induce endometrial malignancy as well as other histopathologic conditions appears to differ between premenopausal and postmenopausal women, Achat Tamoxifen.
In the prevention trial of high-risk women, there was no statistically significant difference in endometrial cancer rates between women treated with tamoxifen and those in the placebo group in the women aged 49 years and younger; however, Achat Tamoxifen, in women aged 50 years and older, the risk ratio was 4.
The annual rate was 3. Another study of women with breast cancer found that premenopausal women, treated or untreated, had no differences in endometrial thickness on ultrasound examination, uterine volume, or histopathologic findings, whereas Achat Tamoxifen women treated with tamoxifen had significantly more abnormalities Several approaches have been explored for screening asymptomatic women using tamoxifen for abnormal Achat Tamoxifen proliferation or endometrial cancer.
Correlation is poor between ultrasonographic measurements of endometrial thickness and abnormal pathology in Achat Tamoxifen tamoxifen users because of tamoxifen-induced subepithelial stromal hypertrophy In asymptomatic women using tamoxifen, screening for endometrial cancer with routine transvaginal ultrasonography, endometrial biopsy, or both has not been shown to be effective 13— Achat Tamoxifen asymptomatic postmenopausal tamoxifen-treated women should not have routine testing to diagnose endometrial pathology, sonohysterography has improved the accuracy of ultrasonography in excluding or detecting anatomic changes, when necessary Other data suggest that low-risk and high-risk groups of postmenopausal patients may be identified before the initiation of tamoxifen therapy for breast cancer 17— Pretreatment screening identified 85 asymptomatic patients with benign polyps in postmenopausal patients with newly diagnosed breast cancer All polyps were removed.
At the time of polypectomy, Achat Tamoxifen, two patients had atypical hyperplasias and subsequently underwent hysterectomies. The incidence of atypical hyperplasia was In addition, polyps developed in There is an increased risk of endometrial polyp formation secondary to tamoxifen use for both premenopausal and postmenopausal women Although the concurrent use of progestin reduces the risk of endometrial hyperplasia and cancer in patients receiving unopposed estrogen, the effect of progestin on the course of breast cancer and on the endometrium of women receiving tamoxifen is not known.
Therefore, such use cannot be advocated as a means of lowering risk in women taking tamoxifen, Achat Tamoxifen. On the basis of these data, the Committee recommends the following: Women taking tamoxifen should be informed about the risks of endometrial proliferation, endometrial hyperplasia, endometrial cancer, and uterine sarcomas, Achat Tamoxifen.
They should be encouraged to promptly report any abnormal vaginal symptoms, including bloody discharge, spotting, Achat Tamoxifen, staining, or leukorrhea. Any abnormal vaginal bleeding, Achat Tamoxifen, bloody vaginal discharge, staining, or spotting should be investigated, Achat Tamoxifen.
Premenopausal women treated with tamoxifen have no known increased risk of uterine cancer and as such require no additional monitoring beyond routine gynecologic care. Unless the patient has been identified to be at high risk of endometrial cancer, routine endometrial surveillance has not proved to be Achat Tamoxifen in increasing the early detection of endometrial cancer in women using tamoxifen.
Such surveillance may lead to more invasive and costly diagnostic procedures and, therefore, is not recommended. Emerging evidence suggests the presence of high-risk and low-risk groups for development of atypical hyperplasias with tamoxifen treatment in postmenopausal women based on the presence or absence of benign endometrial polyps before therapy.
Thus, there may be a role for pretreatment screening of postmenopausal women with transvaginal ultrasonography, and sonohysterography when needed, or office hysteroscopy before initiation of tamoxifen therapy, Achat Tamoxifen. If continued use of tamoxifen therapy is advised and the risks are accepted by the patient, hysterectomy should be considered in women with atypical endometrial hyperplasia. Tamoxifen and endometrial cancer, Achat Tamoxifen. Ann N Y Acad Sci ; Gynaecological monitoring during tamoxifen therapy.
Endometrial cancer in tamoxifen-treated breast cancer patients: J Natl Cancer Inst ; Tamoxifen use in breast cancer Achat Tamoxifen who subsequently develop corpus cancer is not associated with a higher incidence of adverse histologic features.
How much do these drugs lower the risk of breast cancer?
High-grade endometrial carcinoma in tamoxifen-treated breast cancer patients. J Clin Oncol ; Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years Achat Tamoxifen diagnosis Achat Tamoxifen oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Association of tamoxifen and uterine sarcoma. Surveillance, epidemiology, and end results analysis of cases of uterine sarcoma — Tamoxifen in advanced breast cancer.
Cancer Treat Rev ;5: Tamoxifen for prevention of breast cancer: Comparison of endometrial changes among symptomatic tamoxifen-treated and nontreated premenopausal and postmenopausal breast cancer patients. Changes mimicking endometrial neoplasia in postmenopausal, tamoxifen-treated women with breast cancer: Ultrasound Obstet Gynecol ;6: Tamoxifen and the endometrium: Breast Cancer Res Treat ; Prospective longitudinal study of ultrasound screening for endometrial abnormalities in women with breast cancer receiving tamoxifen, Achat Tamoxifen.
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Investigation of endometrial abnormalities in asymptomatic women treated with tamoxifen and an evaluation of the role of endometrial screening. The value of sonohysterography in the prediction of endometrial pathologies in asymptomatic postmenopausal breast cancer tamoxifen-treated patients, Achat Tamoxifen.
Uterine side effects of tamoxifen: Identification of women at high risk of developing endometrial Achat Tamoxifen on tamoxifen.
Eur J Cancer ;36 suppl 4: Endometrial disorders in breast cancer patients on tamoxifen: Benign gynecologic conditions among participants in the Breast Cancer Achat Tamoxifen Trial.
Am J Obstet Gynecol ; American College of Obstetricians and Gynecologists.