What are the therapeutic options for a 48-year-old patient with estrogen (estrogen) and progesterone (progesterone) receptor-positive breast cancer experiencing dyspareunia (painful intercourse), characterized by a burning sensation at the vaginal entrance during sexual activity?

From the Guidelines

For a 48-year-old patient with estrogen and progesterone positive breast cancer experiencing dyspareunia with burning at the vaginal entrance, the most appropriate therapeutic option is to consider low-dose vaginal estrogen therapy, such as Vagifem 10 mcg tablets twice weekly or Estring, after discussion with her oncologist, as systemic absorption is minimal 1.

Therapeutic Options

The patient's symptoms of dyspareunia and burning at the vaginal entrance can be addressed through various therapeutic options, including:

• Non-hormonal vaginal moisturizers like Replens or hyaluronic acid-based products used 2-3 times weekly
• Water-based lubricants such as K-Y Jelly or Astroglide during intercourse
• Pelvic floor physical therapy to help address muscle tension contributing to pain
• Low-dose vaginal estrogen therapy, such as Vagifem 10 mcg tablets twice weekly or Estring, after discussion with her oncologist
• Non-hormonal prescription options, such as dehydroepiandrosterone (DHEA) vaginal inserts (Intrarosa 6.5 mg nightly) or laser therapy

Considerations

When considering therapeutic options, it is essential to take into account the patient's hormone-positive breast cancer status and the potential risks and benefits of each treatment.

• Ospemifene, a selective estrogen receptor modulator, is generally avoided in hormone-positive breast cancer 1.
• Vaginal estrogen therapy has been shown to be effective in treating vaginal atrophy and dyspareunia in postmenopausal women, including those with hormone-positive breast cancer, with minimal systemic absorption 1.
• DHEA vaginal inserts have been shown to improve sexual function and reduce dyspareunia in postmenopausal women, but the safety data for use in survivors of hormonally mediated cancers are limited 1.

Recommendations

Based on the available evidence, the patient should be offered a stepwise approach to managing her symptoms, starting with non-hormonal vaginal moisturizers and lubricants, and progressing to low-dose vaginal estrogen therapy or non-hormonal prescription options as needed, after discussion with her oncologist 1. Pelvic floor physical therapy and cognitive behavioral therapy may also be beneficial in addressing muscle tension and anxiety contributing to pain.

From the FDA Drug Label

The effectiveness and safety of OSPHENA on moderate to severe symptoms of vulvar and vaginal atrophy in postmenopausal women were examined in four placebo-controlled clinical trials (three 12-week efficacy trials and one 52-week long-term safety trial). In Trials 1 and 2, the modified intent-to-treat population of women treated with ospemifene when compared to placebo demonstrated a statistically significant improvement (least square mean change from baseline to Week 12) in the moderate to severe most bothersome symptom of dyspareunia (Trial 1, p=0.0012 and Trial 2, p<0. 0001).

Ospemifene (OSPHENA) may be a therapeutic option for this patient, as it has been shown to improve moderate to severe dyspareunia in postmenopausal women.

• The patient's symptoms of dyspareunia, described as a burning sensation at the entrance of the vagina during sex, are consistent with the symptoms evaluated in the clinical trials.
• Key benefits of ospemifene include statistically significant improvements in dyspareunia, as well as increases in superficial cells and decreases in parabasal cells on a vaginal smear, and a reduction in vaginal pH. 2

From the Research

Therapeutic Options for Dyspareunia

The patient's symptoms of dyspareunia, characterized by a burning sensation at the entrance of the vagina during sex, can be addressed through various therapeutic options.

• The patient's estrogen and progesterone positive breast cancer status is an important consideration when selecting a treatment option.
• Treatment for dyspareunia is focused on the underlying cause, which in this case may be related to vaginal atrophy 3.
• Vaginal estrogen therapy is a common treatment for dyspareunia caused by vaginal atrophy, and it has been shown to be effective in improving symptoms and restoring vaginal and vulvar anatomic changes 4.
• However, for patients with breast cancer, non-hormonal treatments may be preferred to avoid any potential risks associated with estrogen therapy.
• Ospemifene, a selective estrogen receptor modulator (SERM), is a non-hormonal treatment option that has been approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy 5, 6.
• Ospemifene has been shown to have a unique estrogen agonist/antagonist tissue profile, with estrogen-like effects on the vaginal epithelium and neutral to slight estrogenic effects in the endometrium 6.
• This makes ospemifene a potential treatment option for patients with breast cancer who are not candidates for local vaginal estrogen therapy 7.

Considerations for Treatment Selection

When selecting a treatment option for the patient, the following factors should be considered:

• The patient's breast cancer status and any potential risks associated with estrogen therapy
• The patient's symptoms and the underlying cause of dyspareunia
• The patient's preferences and concerns regarding treatment options
• The potential benefits and risks of each treatment option, including ospemifene and vaginal estrogen therapy 3, 5, 4, 6, 7.