From the Guidelines
Intrarosa (prasterone) is contraindicated in patients with a history of breast cancer, as the FDA label warns that exogenous estrogens are contraindicated in women with a history of breast cancer 1.
Key Points
- The safety data for the use of androgen-based therapy, such as prasterone, in survivors of hormonally mediated cancers are limited 1.
- Prasterone has been shown to be effective in reducing dyspareunia in postmenopausal women, but its use in breast cancer survivors is not well established 1.
- The NCCN panel recommends consideration of ospemifene, a selective estrogen receptor modulator, as an option for dyspareunia in survivors without a history of estrogen-dependent cancers 1.
- Vaginal estrogen is the most effective treatment for vaginal dryness leading to sexual dysfunction and has been shown to be effective in treating itching, discomfort, and painful intercourse in postmenopausal individuals, but its use in breast cancer survivors is not well established 1.
- The American Cancer Society/American Society of Clinical Oncology breast cancer survivorship care guideline recommends that hormonal therapies, including vaginal estrogen, should not be used in women with a history of breast cancer who are on aromatase inhibitors 1.
Treatment Options
- Non-hormonal treatments, such as vaginal moisturizers and lubricants, may be considered for breast cancer survivors with vaginal dryness or dyspareunia 1.
- Pelvic physical therapy and integrative therapies, such as yoga and meditation, may also be helpful for breast cancer survivors with sexual dysfunction 1.
- Flibanserin, an FDA-approved medication for hypoactive sexual desire disorder, may be considered as an option for breast cancer survivors with low libido 1.
From the FDA Drug Label
Prastera oral softgels should not be used in patients with any of the following conditions: ... Known, suspected, or history of breast cancer. The answer is: Yes, Intrarosa (prasterone) has a contraindication in patients with a history of breast cancer 2.
From the Research
Intrarosa (Prasterone) and Breast Cancer
- There is no direct contraindication of Intrarosa (prasterone) in patients with a history of breast cancer, as studies suggest it may be a safe option for treating genitourinary syndrome of menopause (GSM) in breast cancer survivors receiving aromatase inhibitors 3, 4.
- A pilot study found that vaginal prasterone improved symptoms and physical examination regarding sexuality and vaginal health in breast cancer survivors, while serum estradiol remained at low levels 3.
- A review of available literature for treatment of GSM in patients with breast cancer and survivors suggests that prasterone is an option for treatment, with minimal elevation in serum estradiol levels and significant improvement in symptoms 4.
- A systematic review and meta-analysis found that among patients treated with prasterone, there was no elevation of serum estradiol concentration, suggesting it may be a safe alternative for breast cancer survivors 5.
Considerations for Treatment
- The decision to offer vaginal hormonal therapy, including prasterone, must be individualized and made jointly with the patient and her oncologist, taking into account the risks and benefits 4.
- Breast cancer survivors receiving antiestrogen therapy, such as aromatase inhibitors, may require careful consideration of treatment options for GSM, with a focus on minimizing systemic absorption of estradiol 4, 6.
- The role of estrogen and progesterone receptors in breast cancer highlights the importance of considering hormone receptor status in patient management, including the use of hormonal treatments for GSM 7.