Evaluation of estrogen and progesterone receptors in non-neoplastic breast tissue of women of reproductive age exposed to tamoxifen and raloxifene: a randomized, double-blind study

Abstract

The objective of the present study was to compare the effects of tamoxifen and raloxifene in non-neoplastic breast epithelium. A randomized, double-blind study was carried out in 57 ovulatory, premenopausal women of 18-40 years of age, who had been diagnosed with fibroadenoma of the breast. The patients were divided into three groups: Group A: placebo, n=20; Group B: tamoxifen 20 mg/day, n = 21; and Group C: raloxifene 60mg/day, n=16. The study medication was given for 22 days starting on the first day of the menstrual cycle. On the 23rd day, the fibroadenoma was removed and a sample of non-neoplastic breast tissue was collected for immunohistochemical evaluation of estrogen and progesterone receptors. Comparison between the mean percentages of stained nuclei in the three groups was performed by analysis of variance and multiple comparisons, using Tukey's method to compare pairwise means, with significance established at P < 0.05. Exposition to tamoxifen or raloxifene resulted in a significant and similar reduction in the mean percentage of stained nuclei for estrogen and progesterone receptors (P<0.0001). Tamoxifen and raloxifene reduce progesterone and estrogen receptor alpha expression significantly and to a similar extent in the non-neoplastic breast tissue of women of reproductive age.

Effect of Tamoxifen and Raloxifene on the Proliferative Activity of the Breast Epithelium in Premenopausal Women

“…Tamoxifen and raloxifene can reduce progesterone and ER alpha expression to a similar extent in the non-neoplastic breast tissue of women of reproductive age. 12 The capacity of both tamoxifen and raloxifene to reduce the proliferative activity of the normal breast epithelium in premenopausal women has also been well established in previous studies. 13–15 Nevertheless, a direct comparison of the proliferative activity of these two compounds in the normal breast epithelium and their potential use as chemoprevention in premenopausal women are issues that remain to be determined.…”

Effect of the Use of Gnrh Analogs in Low-Grade Cerebral Glioma

“…Its receptors have been found in several types of brain tumors, such as chordomas, craniopharyngiomas, and gliomas [31]. However, the best-known association is with meningiomas [32]. This tumor occurs twice as often in women as in men [33].…”

Double blind randomized controlled trial of efficacy of ormeloxifene for the treatment of fibroadenoma (The FIBROCENT study)

“…5,6 In the previous decade, multiple pharmacological therapies have been used with conflicting evidence. [7][8][9] Centchroman or Ormeloxifene is a non-steroidal selective estrogen receptor modulator which is being used to treat fibroadenoma. 9,10 Centchroman (Ormeloxifene) was developed at the Central Drug Research Institute, Lucknow, India.…”

“…However, observation and reassurance has become the standard of care if the core biopsy report is benign 5,6 . In the previous decade, multiple pharmacological therapies have been used with conflicting evidence 7–9 …”