Tamoxifen and The Endometrium

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists
College Statement C-Gyn 12

1st Endorsed: May 1996 Current: March 2012 Review: March 2015
C-Gyn 12
Tamoxifen and the Endometrium

Tamoxifen is the endocrine treatment of choice for selected patients with breast cancer, and has been shown to have a preventative role in healthy women at increased risk of developing breast cancer. Although Tamoxifen functions as an antioestrogen, it also has weak and variable oestrogenic effects. Because of its weak oestrogenic activity, Tamoxifen produces a number of side effects on the female genital tract. These may include: Oestrogen-like changes in the vaginal epithelium of some patients. Stimulation of endometriosis, with worsening of symptoms in some patients. There has been one case report of an endometrioid carcinoma arising from an ovarian endometriotic focus. Stimulation of the growth of benign fibroids. An increased incidence of benign endometrial polyps, proliferation and hyperplasia. Patients that have an endometrial lesion detected prior to commencing Tamoxifen have a statistically significant higher risk of developing atypical lesions at two years compared to patients that did not have a pre-existing endometrial lesion.1 A two to three fold increased incidence of endometrial carcinoma (rate of endometrial cancer of 1.26 per 1,000 patient years). The risk is dependent on the dose and duration of use of Tamoxifen.2 The risk of developing endometrial cancer in patients on Tamoxifen prophylaxis is only observed in post-menopausal women (RR = 4.01).3 The stage and grade of tumours found in women on standard doses of Tamoxifen is comparable to those tumours found in women not taking Tamoxifen. There have been isolated reports of uterine sarcoma occurring in women taking Tamoxifen.
Because the incidence of endometrial carcinoma is very low (2-3/ 1000 women per year) during or after Tamoxifen therapy, and because there is no convincing evidence that the stage or grade of these tumours differs from that seen in the general population, there are no data to support active investigation of asymptomatic women at the present time. Pre-menopausal women are less likely to develop endometrial lesions and routine screening is not recommended. Post-menopausal women are at higher risk of developing a significant endometrial lesion if they are found to have a pre-treatment endometrial lesion.
1 RANZCOG College Statement: C-Gyn 12
It is recommended that: All women taking Tamoxifen should be informed of its potential side effects, including specifically the two to three fold increased incidence of endometrial cancer. They should be warned of the possible symptoms of endometrial cancer, including intermenstrual or post-menopausal bleeding, abnormal vaginal discharge, or pelvic pain. If these symptoms develop they should be advised to seek immediate medical assessment. All women on Tamoxifen should have a baseline pelvic examination. This should include a speculum examination to determine the presence or absence of a cervix and to take a pap smear (if appropriate), and a bi-manual examination to evaluate the size of the uterus and the adnexa. Routine screening of asymptomatic women taking Tamoxifen, using either ultrasound or endometrial biopsy, is not recommended. If an individual patient expresses particular concern about the possibility of developing endometrial cancer, or is felt to be at additional risk because of a family history of breast, ovarian, endometrial or bowel cancer, the patient should be referred to a gynaecologist and offered investigation at the discretion of the gynaecologist. When indicated, a vaginal ultrasound should be performed by a skilled gynaecological ultrasonographer. This would seem to be the least invasive and most useful initial investigation. It should be recognised that interpretation of vaginal ultrasound may be difficult and at times may be misleading, especially in the asymptomatic patient. Ultrasonography may select out those women with bleeding who have an atrophic or inactive endometrium from those with possible pathology (who may require further intervention). Because of the absence of data establishing the sensitivity, specificity, clinical value and cost effectiveness of active investigation of asymptomatic women such research should be encouraged and supported. These recommendations, which apply to both the therapeutic and prophylactic use of Tamoxifen, will be reviewed regularly in the light of any new evidence which may emerge.
References 1. Berliere M, Radikov A, Galant C, Piette P, Marbaix E, Donnez J. Identification of women at high risk of developing endometrial cancer on tamoxifen. Eur J Cancer 2000; 36: S35-36. 2. Fisher B, Costantino JP, Redmond CK, Fisher ER, Wickerham DL, Cronin WM. Endometrial cancer in tamoxifen-treated breast cancer patients: findings from the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14. J Natl Cancer Inst 1994; 86: 527-37. 3. Fisher B, Constantino JP, Wickerham DL, Redmond CK, Kavanagh M, Cronin WM et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998; 90: 1371-88. Other suggested reading Gynaecologic Surveillance of Women on Tamoxifen: First Do No Harm, Editorial, Runowicz, Carolyn D. MD, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY. Journal of Clinical Oncology (C) 2000 American Society of Clinical Oncology; Volume 18 (20): 3457-3458.
RANZCOG College Statement: C-Gyn 12
Barakat RR, Gilewski TA, Almadrones L, Saigo PE, Venkatraman E, Hudis C, Hoskins WJ. Effect of Adjuvant Tamoxifen on the Endometrium in Women with Breast Cancer: A Prospective Study Using Office Endometrial Biopsy. Journal of Clinical Oncology (C) 2000 American Society of Clinical Oncology; Volume 18 (20): 3459-3463. Gerber B, Krause A, Muller H, Reimer T, Kulz T, Makovitzky J, Kundt G, Friese K. Effects of Adjuvant Tamoxifen on the Endometrium in Postmenopausal Women with Breast Cancer: A Prospective Long-Term Study Using Transvaginal Ultrasound. Journal of Clinical Oncology (C) 2000 American Society of Clinical Oncology; Volume 18 (20): 3464-3470. Fung MF, Reid A, Faught W, Le T, Chenier C, Verma S, Brydon E, Fung KF. Prospective longitudinal study of ultrasound screening for endometrial abnormalities in women with breast cancer receiving tamoxifen. Gynecol Oncol 2003 Oct; 91 (1): 154-9. Fleischer AC, Wheeler JE, Lindsay I, Hendrix SL, Grabill S, Kravitz B, MacDonald B. An assessment of the value of ultrasonographic screening for endometrial disease in postmenopausal women without symptoms. Am J Obstet Gynecol 2001 Jan; 184 (2): 70-5. Geller BA, Vogel VG. Chemoprevention of breast cancer in postmenopausal women. Breast Dis 2005-2006; 24: 79-92. Links to other related College Statements (C-Gen 2) Guidelines for consent and the provision of information regarding proposed treatment
http://www.ranzcog.edu.au/component/docman/doc_download/899-c-gen-02-guidelines-for-consent-and-theprovision-of-information-regarding-proposed-treatment-.html
Disclaimer This College Statement is intended to provide general advice to Practitioners. The statement should never be relied on as a substitute for proper assessment with respect to the particular circumstances of each case and the needs of each patient. The statement has been prepared having regard to general circumstances. It is the responsibility of each Practitioner to have regard to the particular circumstances of each case, and the application of this statement in each case. In particular, clinical management must always be responsive to the needs of the individual patient and the particular circumstances of each case. This College statement has been prepared having regard to the information available at the time of its preparation, and each Practitioner must have regard to relevant information, research or material which may have been published or become available subsequently. Whilst the College endeavours to ensure that College statements are accurate and current at the time of their preparation, it takes no responsibility for matters arising from changed circumstances or information or material that may have become available after the date of the statements.
RANZCOG College Statement: C-Gyn 12

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The Royal Australian and New Zealand College of Obstetricians and Gynaecologists

College Statement C-Gyn 12

Tamoxifen and the Endometrium

RANZCOG College Statement: C-Gyn 12

RANZCOG College Statement: C-Gyn 12

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