Abnormalities detected on transvaginal ultrasonography in tamoxifen-treated postmenopausal breast cancer patients may represent endometrial cystic atrophy.
ABSTRACT This study was conducted to examine the histopathologic changes in tamoxifen-treated postmenopausal patients with endometrial thickness > or = 5 mm with transvaginal ultrasonography.
Thirty-five tamoxifen-treated postmenopausal breast cancer patients underwent transvaginal pelvic ultrasonography with endometrial thickness > or = 5 mm followed by either curettage-hysteroscopy (n = 24), or hysterectomy (n = 11). Endometrial histopathologic findings were examined.
Overall, endometrial polyps were the most common histopathologic finding (23 of 35 patients). Endometrial cystic atrophy was uncommonly detected in patients undergoing curettage-hysteroscopy (1 of 24 patients) compared with patients undergoing hysterectomy (9 of 11 patients). No cases of endometrial cancer or hyperplasia were detected.
Endometrial polyps were a frequent finding in tamoxifen-treated postmenopausal women who had endometrial thickness > or = 5 mm with the use of transvaginal ultrasonography. Endometrial cystic atrophy may explain "thickened endometrium" on transvaginal ultrasonography in this patient population with no evidence of endometrial polyps, hyperplasia, or adenocarcinoma after surgical evaluation.
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ABSTRACT: Objective This study aims to assess the endometrial safety of ospemifene based on phase 2/3 clinical trials of postmenopausal women with up to 52 weeks of exposure to ospemifene 60 mg/day versus placebo. Methods Endometrial safety was evaluated in a development program of six randomized, double-blind, placebo-controlled, parallel-group studies of postmenopausal women aged between 40 and 80 years who had vulvar and vaginal atrophy. Participants were randomized 1:1 to ospemifene 60 mg/day or placebo in one 6-week trial and three 12-week trials; one of the 12-week trials had a 40-week extension study. In a separate 52-week trial, women were randomized 6:1 to ospemifene 60 mg/day or placebo. Endometrial safety was assessed by endometrial histology (biopsy), transvaginal ultrasound, and gynecologic examination. Results In these trials, 1,242 women who received ospemifene 60 mg/day and 924 women who received placebo were evaluable for safety. Endometrial hyperplasia occurred in less than 1% of women treated with ospemifene; no endometrial cancer was reported. The mean (SD) increase in endometrial thickness among women treated with ospemifene was 0.51 (1.54) mm at 12 weeks, 0.56 (1.61) mm at 6 months, and 0.81 (1.54) mm at 12 months. Women who received placebo had a mean (SD) increase of 0.07 (1.23) mm at 12 months. Conclusions These clinical trial data indicate that up to 52 weeks of treatment with oral ospemifene 60 mg/day was safe for the endometrium. There was no increase in the incidence of endometrial cancer or hyperplasia among postmenopausal women treated with ospemifene compared with placebo.Menopause (New York, N.Y.) 06/2014; 22(1). DOI:10.1097/GME.0000000000000275 · 2.81 Impact Factor
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ABSTRACT: Aim and background. A reduction of gynaecological adverse events has been reported in trials comparing aromatase inhibitors with tamoxifen as adjuvant treatment in postmenopausal women with early breast cancer, but there is a paucity of randomised studies specifically investigating their effects on the uterus. We report here the results of a prospective phase III trial comparing the effects of tamoxifen and exemestane by transvaginal ultrasound (TVUS). Patients and methods. Postmenopausal patients with ER+ early breast cancer were randomised to receive tamoxifen 20 mg once daily or exemestane 25 mg once daily as adjuvant hormone therapy. TVUS was performed at baseline and at 6 and 12 months to measure endometrial thickness (ET) and uterine volume (UV).Results. A total of 123 women were randomised to tamoxifen (n = 61) or exemestane (n = 62). A significantly higher proportion of patients in the tamoxifen group had increased ET at 6 and 12 months from randomisation compared with the exemestane group (66.1% and 64.3% versus 12.1% and 6.8%, respectively; P <0.0001). Mean ET and UV also significantly increased with tamoxifen compared to exemestane at both time points (P <0.01 for all comparisons). Conclusion. Tamoxifen is associated with endometrial thickening and increased uterine volume in a significant proportion of postmenopausal women with early breast cancer. Our study confirms the lack of endometrial effects of exemestane, which may be of interest to patients and clinicians when choosing among adjuvant endocrine options for breast cancer.
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ABSTRACT: “Tamoxifen” (TAM) is the anti-estrogenic treatment of choice for breast cancer patients. The proliferative effects of postmenopausal TAM have been associated with endometrial hyperplasia, polyps, endometrial carcinoma and endometrial sarcoma. TAM treated patients also have higher incidence of leiomyomas, adenomyosis and endometriosis, as increased risk of ovarian cysts. Transvaginal ultrasound (TVS) is the first line imaging modality in the surveillance of women treated with TAM. The commonest endometrial pattern is thickening with cystic areas, features that can be better characterized by hysterosonography or magnetic resonance. On T2-WI thickened and heterogeneous endometrium with lattice-like enhancement, as the enhancement of the endometrial-miometrial interface have been associated with worse prognosis (polyps, atypical hyperplasia, cancer). The knowledge of the gynecological effects of TAM and their imaging features promotes early diagnosis and adequate orientation of these patients.