What are the considerations for a 55-year-old female with no family history of breast cancers, who has a mammogram showing a small group of microcalcifications in the left upper outer quadrant, regarding the use of vaginal topical estrogen (estrogen) therapy?

From the Guidelines

Vaginal topical estrogen can be considered for this 55-year-old female with breast microcalcifications, but with caution, as the most recent and highest quality study suggests its safety in postmenopausal women, including breast cancer survivors 1. When considering the use of vaginal topical estrogen therapy, it is essential to weigh the benefits against the potential risks. The patient's lack of family history of breast cancer and the presence of a small group of microcalcifications in the left upper outer quadrant of the breast should be taken into account.

• The microcalcifications should be further evaluated with additional imaging and possibly biopsy to rule out malignancy, as they can sometimes indicate early breast cancer.
• Vaginal estrogen preparations, such as Vagifem (estradiol vaginal tablets 10 mcg) inserted vaginally twice weekly, or Estrace vaginal cream (0.01% estradiol) 0.5-1g applied 1-3 times weekly, result in minimal systemic absorption compared to oral or transdermal formulations, making them relatively safer options for women with potential breast concerns 1.
• Regular mammographic follow-up is essential to monitor the microcalcifications, and the patient should report any concerning breast symptoms during treatment immediately.
• For severe vaginal symptoms, non-hormonal options like vaginal moisturizers (Replens, Hyalo Gyn) or lubricants could be considered as first-line alternatives if there are concerns about using any form of estrogen.
• A large cohort study of almost 50,000 patients with breast cancer followed for up to 20 years showed no evidence that there was a higher risk of breast cancer–specific mortality in those using vaginal estrogen, supporting the safety of this treatment option 1.

From the FDA Drug Label

CONTRAINDICATIONS Estrogens should not be used in individuals with any of the following conditions: 2. Known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease. 3. Known or suspected estrogen-dependent neoplasia.

The patient has a mammogram showing a small group of microcalcifications in the left upper outer quadrant, which may indicate a potential breast cancer risk.

• Key consideration: The presence of microcalcifications may suggest a suspected breast cancer, which is a contraindication for estrogen therapy, as stated in the drug label 2.
• Clinical decision: Given the potential risk of breast cancer, it is recommended to avoid vaginal topical estrogen therapy in this patient until further diagnostic evaluation is completed to rule out malignancy.
• Recommendation: The patient should undergo further diagnostic testing to determine the nature of the microcalcifications before considering estrogen therapy 2.

From the Research

Considerations for Vaginal Topical Estrogen Therapy

• The patient has no family history of breast cancer, but has a mammogram showing a small group of microcalcifications in the left upper outer quadrant, which may be a consideration for the use of vaginal topical estrogen therapy 3, 4.
• Vaginal atrophy is a common condition in postmenopausal women, affecting up to 60% of women, and topical vaginal estrogen preparations can reverse atrophic changes and relieve associated symptoms while avoiding systemic effects 3.
• Low-dose vaginal estrogen treatment is considered safe and efficient for most women with vulvovaginal atrophy, including those with a history of breast cancer, although concerns about cancer recurrence should be taken into account 4, 5.
• Non-hormonal approaches are recommended as the first-line treatment for managing urogenital symptoms or atrophy-related urinary symptoms in women with a history of estrogen-dependent breast cancer 6.
• The decision to use vaginal estrogen therapy should be made in coordination with the patient's oncologist and preceded by an informed decision-making and consent process, considering the benefits and potential risks of low-dose vaginal estrogen 6.

Safety of Vaginal Topical Estrogen Therapy

• Studies have shown that low-dose vaginal estrogen therapy does not appear to be associated with an increased risk of recurrence of breast cancer in women previously treated for breast cancer 5, 7.
• However, the safety of hormonal treatment remains uncertain in breast cancer survivors, and more data are needed to support the safety and efficacy of alternative treatments such as ospemifene 5.
• The use of vaginal estrogen therapy should be reserved for patients who are unresponsive to non-hormonal remedies, and the decision to use it should be made on a case-by-case basis, taking into account the individual patient's risk factors and medical history 6.