ACOG supports vaginal estrogen use for difficult symptoms in hormone-sensitive breast cancer

In a recent committee opinion, the American College of Obstetricians and Gynecologists (ACOG) approved the use of low-dose vaginal estrogen products to relieve vaginal dryness, painful sex and related symptoms in women treated for hormone receptor-positive breast cancer.

Such products – estrogen-based creams, vaginal rings and vaginal tablets – may be used when non-hormonal treatments have proven unsuccessful, ACOG noted. Women should receive information on the possible benefits and risks of vaginal estrogen use and coordinate the decision with their oncologist, the group stated.

“The committee opinion reflects current practice,” says Halle Moore, MD, a medical oncologist at the Cleveland Clinic’s Taussig Cancer Institute. “For a while, there have been selected breast cancer patients for whom we’ve used vaginal estrogens of various sorts, usually only when non-hormonal treatments are not adequate.”

Background

There has been debate for years about whether it is safe for women with breast cancer, especially types that grow in response to estrogen, to use estrogen products to lessen menopausal symptoms. Concern centers on whether even small amounts of the hormone would cause breast cancer to return.

Vaginal and urinary problems can be brought on by menopause, either natural or caused by breast cancer treatments. Women may have loss of lubrication, bleeding, infections, and difficulty or pain that makes intercourse uncomfortable – and for some, impossible. Some women stop breast cancer therapies because of these symptoms.

For many women, estrogen products work better than non-hormonal ones in treating such problems. The ACOG opinion relates only to products used in and around the vagina. These deliver a low dose of estrogen into vaginal tissues, a small amount of which enters the bloodstream.

Systemic, or whole body, estrogen treatment usually delivers higher hormone levels and circulates through the bloodstream. It is generally considered not safe for use in women who have breast cancer.

The ACOG opinion does not address the use of low-dose estrogen products in women with breast cancer types that do not grow because of estrogen. It is believed they are not at risk of recurrence from these products.

Non-estrogen treatments

The first choice to relieve menopausal symptoms in women diagnosed with estrogen receptor-positive breast cancer should be treatments that don’t use hormones, the ACOG committee stated. These include vaginal moisturizers, such as Replens and Fresh Start, and lubricants such as Astroglide or K-Y Jelly.

Non-hormonal products help some women have the vaginal intercourse they want, which may solve other discomforts. “Regular sex, one time a week or so, has a very beneficial effect on the vagina” and can be enough to end symptoms, says JoAnn V. Pinkerton, MD, professor of obstetrics and gynecology, and division director of midlife health at the University of Virginia Health System.

Other non-estrogen treatments are getting attention, but were not included in the ACOG opinion. Vaginal laser therapy uses an FDA-approved device to reverse vaginal atrophy, or thinning of vaginal walls, with no hormones. This method, which is expensive, requires three initial treatments and additional yearly treatment. The long-term effects are not yet known. The first randomized clinical trial is planned to compare this to vaginal estrogen cream, but has not opened as of May 2016.

Suppositories containing the hormone DHEA, when inserted in the vagina, have shown good results in a phase 3 clinical trial. This treatment helps with dryness and painful sex, much as estrogen does, but DHEA does not enter the bloodstream.

Vaginal estrogen use  

Physicians may differ by specialty on the question of using estrogen products after a breast cancer diagnosis. “[Gynecologists] in general are much more used to prescribing estrogens and have a degree of comfort about it. As oncologists, our main goal is to try to keep the cancer away. Then, second, to manage whatever toxicities are present from the various symptoms,” Dr. Moore says.

“You need a provider who is comfortable assessing menopausal vaginal changes for narrowing, loss of elasticity and pH changes, who can help you work through what you need,” says Dr. Pinkerton, who is also executive director of the North American Menopause Society (NAMS). If a woman’s gynecologist suggests using vaginal estrogen, Dr. Pinkerton adds, she can then talk with her medical oncologist about how it might fit with her breast cancer treatment.

The ACOG opinion noted that low-dose vaginal estrogens do not raise blood levels of estrogen above “normal menopausal range” and that estrogen in the vaginal ring and suppository tablet is absorbed least into the body. Vaginal estrogen should be used at the lowest dose and for the shortest time until symptoms improve, the group stated.

Safety

According to ACOG, research data do not show a higher risk of recurrence among women using vaginal estrogen products.

Yet there is concern that, for women who use aromatase inhibitors, vaginal estrogen may raise estrogen blood levels and increase the risk of recurrence. It does not have that effect on women taking tamoxifen, due to differences in how the medicines act.

“Saying the data don’t show an increased risk of breast cancer recurrence in women using vaginal estrogen…is not the same as saying the data proved no risk,” says Dr. Moore. “It’s important to develop some guidelines to help people understand the risks and benefits about what we know about the various treatments, although quite a bit is still not well known.”

NAMS is seeking to have the warning information on low-dose estrogen products changed. Right now, it is the same as on systemic estrogen. Dr. Pinkerton says NAMS agrees with ACOG that low-dose estrogen “used properly has levels of estrogen in the post-menopausal range and, therefore, minimal risks.” NAMS also wants wording added that women with histories of breast or uterine cancer should consult their oncologists before using the products.

Committee on Gynecologic Practice, The American College of Obstetricians and Gynecologists, The Use of Vaginal Estrogen in Women With a History of Estrogen-Dependent Breast Cancer, Number 659, March 2016.

This article was supported by the Grant or Cooperative Agreement Number 1 U58 DP005403, funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention or the Department of Health and Human Services.