Management of urogenital atrophy in breast cancer patients: a systematic review of available evidence from randomized trials

Abstract

Symptoms of urogenital atrophy are common in breast cancer survivors. Its optimal management is currently unknown. A systematic review of randomized controlled trials (RCTs) evaluating treatments for urogenital atrophy in breast cancer patients was performed. EMBASE, Ovid Medline and the Cochrane Library were searched from 1946 to November 2014. Outcomes included improvements in both vaginal symptoms (e.g., dryness, pain, dyspareunia and itching) and vaginal hormone response measured by validated scales [e.g., Vaginal Health Index (VHI) and Vaginal Maturation Index (VMI)]. Of 430 unique citations identified, 4 studies (n = 196) met inclusion criteria. Interventions included pH-balanced gel, Replens(®), lidocaine, Estring(®) and Vagifem(®). Sample sizes ranged from 7 to 98 patients. Given the heterogeneity of the studies, a narrative synthesis of results was performed. One study of 98 patients suggested that vaginal pH-balanced gel (mean VHI 5.00 ± 0.816, mean VMI 51.18 ± 3.753) was more efficient than placebo (VHI 16.98 ± 3.875, p < 0.001, VMI 47.87 ± 2.728, p < 0.001) at 12 weeks in providing vaginal symptom relief. In patients who used lidocaine, 90 % had reduced dyspareunia compared to saline in a study of 46 patients. Although increased serum estradiol occurred, both Estring(®) and Vagifem(®) were shown to improve quality of life and VMI in a study of seven patients. Treatment of urogenital atrophy remains a challenging issue and there is a paucity of RCT evidence addressing this knowledge gap. It is evident that more prospective trials are needed.

American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline

“…It is important to counsel patients concerning possible sexual dysfunction remedies, including treatments for vaginal dryness. Nonhormonal, water‐based lubricants and moisturizers remain the primary treatment . Silicone‐based products may last longer than water‐based or glycerin‐based products.…”

“…A combination of therapies may provide additional short‐term comfort. Hormonal therapies, such as a low‐dose estrogen vaginal tablets or an estradiol vaginal ring, may be recommended for vaginal dryness because of urogenital atrophy, although results commonly take approximately 6 to 12 weeks . The safety of these therapies in women with a history of breast cancer is not well established at this time.…”

“…Nonhormonal, water-based lubricants and moisturizers remain the primary treatment. 158 Siliconebased products may last longer than water-based or glycerin-based products. A combination of therapies may provide additional short-term comfort.…”

“…Hormonal therapies, such as a low-dose estrogen vaginal tablets or an estradiol vaginal ring, may be recommended for vaginal dryness because of urogenital atrophy, although results commonly take approximately 6 to 12 weeks. 158,159 The safety of these therapies in women with a history of breast cancer is not well established at this time. The level of estrogen absorption is variable, which raises concerns in patients who have a history of breast cancer.…”

Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology

“…The NCCN Panel recommends treatment with local vaginal estrogen and referral to an appropriate specialist. 130,133 See “Treatment of Vaginal Dryness,” (previous section) for a discussion on the safety of vaginal estrogen.…”