Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study

Abstract

The study aim is to evaluate the efficacy and safety of two low-dose vaginal estrogen treatments (ETs) and of a non-hormonal vaginal moisturizer in postmenopausal breast cancer survivors with urogenital atrophy. Eighteen patients receiving estriol cream 0.25 mg (n = 10) or estradiol tablets 12.5 microg (n = 8) twice/week for 12 weeks were evaluated and compared with eight patients treated with polycarbophil-based moisturizer 2.5 g twice/week. Severity of vaginal atrophy was assessed using subjective [Vaginal Symptoms Score (VSS), Profile of Female Sexual Function (PFSF)] and objective [Vaginal Health Index (VHI), Karyopycnotic Index (KI)] evaluations, while safety by measuring endometrial thickness and serum sex hormones levels. After 4 weeks, VSS and VHI were significantly improved by both vaginal ETs, with further improvement after 12 weeks. PFSF improved significantly only in estriol group (p = 0.02). Safety measurements did not significantly change. Vaginal moisturizer improved VSS at week 4 (p = 0.01), but score returned to pre-treatment values at week 12; no significant modification of VHI, KI, PFSF was recorded. Both low-dose vaginal ET are effective for relieving urogenital atrophy, while non-hormonal moisturizer only provides transient benefit. The increase of serum estrogens levels during treatment with vaginal estrogen at these dosages is minimal.

A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy

“…Patients who wish to consider HT after a diagnosis of breast cancer should be informed that definitive evidence on its influence in prognosis of breast cancer is lacking. The results of observational studies (which are fraught with potential biases) [Biglia et al 2010;Manson et al 2014;Santen et al 2002;Cold et al 2015] and a recent phase II RCT (evaluating use of estradiol-releasing vaginal ring 7.5 µg/d for 12 weeks) have been reassuring with respect to safety [Melisko et al 2016]. However, a single RCT suggested that HT in breast cancer survivors may increase breast cancer recurrence or new breast cancers by 2-3-fold [Holmberg and Anderson, 2004].…”

“…Tibolone is a synthetic steroid that after absorption is rapidly converted to its active form which has weak estrogenic, progestagenic, and androgenic properties [Biglia et al 2010]. It is classified as a selective tissue estrogenic activity regulator [Indhavivadhana et al 2010;Biglia et al 2010], and has been shown to improve vaginal dryness [Nappi et al 2006;Saeideh et al 2010] and may have a favourable effect on sexual function [Modelska and Cummings, 2002].…”

“…It is classified as a selective tissue estrogenic activity regulator [Indhavivadhana et al 2010;Biglia et al 2010], and has been shown to improve vaginal dryness [Nappi et al 2006;Saeideh et al 2010] and may have a favourable effect on sexual function [Modelska and Cummings, 2002].…”

Use of lactobacilli and estriol combination in the treatment of disturbed vaginal ecosystem: a review

“…in breast cancer survivors taking aromatase inhibitors. Due to lack of proper safety data, the available clinical experience remains controversial and requires further investigation (42,43). The clinical studies for E3 have been reviewed by Head (2).…”

Vaginale Östrogentherapie bei Mammakarzinompatientinnen

“…Zudem ist die Verbesserung der Symptome bei Verwendung von Befeuchtungsmitteln häufig nur von kurzer Dauer. Dies konnte in einer Studie an 26 Patientinnen, die mit Östradiol, Östriol oder Befeuchtungsmitteln behandelt wurden, gezeigt werden [3]. …”