Expert Stresses Importance of Pairing AI Treatment With Preventive Sexual Counseling

Leslie R. Schover, PhD

Leslie R. Schover, PhD

During a presentation at the 2017 Miami Breast Cancer Conference, Leslie R. Schover, PhD, stressed the importance of preventive sexual counseling in reducing sexual dysfunction resulting from the treatment of breast cancer patients with aromatase inhibitors (AIs); however, she says, intervention should be provided early in treatment and supported by encouragement from providers, Leslie R. Schover, PhD, said in a presentation at the 2017 Miami Breast Cancer Conference.

Schover is the founder of Will2Love, an online resource to help guide cancer survivors in sexual wellness and parenthood. She was previously a professor of behavioral science at The University of Texas MD Anderson Cancer Center, where she created and evaluated innovative treatment programs for cancer and sexual health. She has also served as a staff psychologist at the Cleveland Clinic Foundation.

The importance of AIs and their effect on sexuality is growing as more women are being prescribed this treatment. In addition, there is potential for the course of these drugs to be extended from 5 years up to 10 years, and vaginal/vulva adverse events (AEs) grow worse the longer patients stay on AIs. These sexual issues are often overlooked or underestimated. Schover said this is because many American women over the age of 50 are no longer sexually active and because study questionnaires on sexual health are inadequate.

AIs and Sexual Dysfunction

Schover led a survey study of 139 women within the Department of Breast Medical Oncology at MD Anderson

Cancer Center with localized breast cancer.¹Ninety-three percent of the women reported some level of sexual dysfunction after using AIs as adjuvant therapy after 18 to 24 months. Additionally, 75% of the women reported being distressed about the effects AIs had on their sexual health, whereas one-quarter of the women stopped all partner sex due to severe genital pain and dryness. About 70% of women attributed sexual problems to the initiation of AI therapy. The main issues, Schover explained, were vaginal dryness and dyspareunia.

That survey provided a benchmark for a follow-up investigation: a randomized pilot trial designed to evaluate the

effect of early intervention on sexual dysfunction during the first year on AIs.²The study also sought to compare efficacy of prebiotic and hyaluronic-acid, over-the-counter, estrogen-free vaginal moisturizers.

The MD Anderson study enrolled 57 postmenopausal women with early-stage breast cancer who started AIs as first-time endocrine therapy. All of the patients received a detailed handout covering the management of AEs from AIs as well as follow-up questionnaires after 6 months and 1 year on treatment. In addition, half of the study participants received a kit of products to help treat sexual dysfunction. This included the vaginal moisturizer, water-based lubricant, a vaginal dilator, and instructions on how to use everything. This active treatment group was also given access to an online information resource and coaching over the phone. Within this active treatment group, half received the prebiotic over-the-counter vaginal moisturizer and half received the hyaluronic-acid product.

Included in the instructions that all participants received was an explanation about the importance of adhering to AI treatment. “Usually, only maybe 50% of women finish the 5 years of an aromatase inhibitor, or of tamoxifen,” Schover explained. This nonadherence is usually a result of the side effects AEs that women experience from these drugs, including sexual dysfunction. The aim was to use these interventions on a preventative basis, to stop the sexual problems that occur when starting on an AI.

Of the findings from this study, Schover said, “What we had trouble demonstrating, except on a couple of

measures, was that the active treatment groups were better than the usual care. They both were in far better shape in a year than the women in our benchmark survey.” Compared with the 24% of patients who stopped having partner sex completely in the benchmark study, only 9% stopped in this study. Sexual dysfunction was also not as prevalent in this study as it was in the benchmark study. Overall, the patients’ sexual function over the study period was fairly stable. Schover expected a sharp decline, based on the earlier data.

Schover listed several limitations, including the size of the study and the likelihood of undertreatment. The recommended frequency for the vaginal moisturizer is 5 to 7 times a week. “We told them to use it 2 to 3 times a week,” Schover explained. “And when we looked at how often women actually used it, it was an average of about twice a week.”

There was also a regression between the 6-month outcomes and the 12-month outcomes. Schover attributes this to the limited 6-month supply that the researchers gave women. “A lot of them didn’t go out on their own and buy more,” she said.

Not all women used the vaginal dilator and, combined with that, there is uncertainty whether these are a viable intervention, Schover said. “There are some data suggesting that women who are sexually inactive have more vaginal atrophy, and we don’t know what’s the chicken and what’s the egg.”

The products in this study were over-the-counter moisturizers and did not contain vaginal estrogen. Schover said

that one of the most important findings from the study was that women were able to maintain a reasonably normal sex life, or they didn’t have their sex life decline by much.

Many patients as well as oncologists are wary of using vaginal estrogen with breast cancer and AIs. The goal

of hormone therapy for patients with breast cancer is to remove as much estrogen as possible from the system. However, as Schover explained, “the vaginal walls and lining have many tiny blood vessels. It’s easy for any vaginal

estrogen to get into the bloodstream.” There are many unknowns when it comes to using vaginal estrogen, though, and it’s difficult for clinicians to conduct safety test on this issue because “women don’t even want to risk participating in them.” Also, to properly monitor the amount of estrogen in the bloodstream requires expensive equipment, which is usually reserved for research purposes.

Some women may require a hormonal, vaginal treatment to overcome painful intercourse. However, Schover is a proponent of attempting other methods first. “Let’s use treatment algorithms and do these ‘do no harm’ approaches first, with totally nonhormonal lubricants and moisturizers.”

Based on the results, Schover considers this a promising study that deserves a follow-up. For future studies, Schover suggests eliminating the prebiotic moisturizer, as it was “clearly less effective” than the hyaluronic acid-based product. Additionally, she would provide stricter instructions, a longer-lasting supply of products, and initiate follow-up check-ins sooner.

“It’s much better to prescribe these things and give the instructions preventively, rather than wait until women have horrible problems and have stopped sex for 6 months,” Schover said. Further, many women just never receive adequate instructions on how to use the nonhormonal options.

References:

1. Schover LR, Baum GP, Fuson LA, Brewster A, Melhem-Bertrandt A. Sexual problems during the first two years of adjuvant treatment with aromatase inhibitors.J Sex Med. 2014;11(12):3102-11. doi: 10.1111/jsm.12684
2. Advani P, Brewster AM, Baum GP, Schover, LR. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. Manuscript under review.