Safety a Concern for Vulvovaginal Atrophy Treatments in Breast Cancer Survivors

By Marilynn Larkin

September 14, 2020

NEW YORK (Reuters Health) - For women with breast cancer and vulvovaginal atrophy (VVA) unresponsive to non-hormonal therapy, other treatments may be effective, but safety is "controversial and a major concern," say authors of a systematic review.

"I was surprised that clinical studies assessing the safety of the vaginal laser or androgen therapies, with regard to serum estradiol levels or relapse, are still lacking in breast cancer survivors," Dr. Camil Castelo-Branco of Hospital Clinic, Villarroel in Barcelona told Reuters Health by email.

"We found that non-hormonal therapies remain the first-line treatment for mild-moderate VVA," he noted. "According to the current recommendations of the North American Menopause Society (as well as other international menopause societies), the use of low-dose vaginal estrogen may be considered if there is no improvement using non-hormonal treatments in BCS with VVA."

"However, clinicians must take into account (evidence) that vaginal estrogen therapy may increase serum estrogen levels, possibly increasing the risk of breast cancer recurrence," he said. "Vaginal laser and androgen therapies seem to be effective, but data about safety are still lacking."

As reported in Maturitas, a literature search through April 2020 yielded 24 eligible studies assessing treatment options for genitourinary syndrome of menopause or VVA in breast cancer survivors: eight evaluated local estrogen therapy; seven reported on vaginal laser therapy; three summarized the effects of vaginal estrogens; and the remaining six were related to non-hormonal options (excluding laser).

Non-hormonal treatments included classic moisturizers and lubricants based on aqueous gel, and innovative options including molecules such as autologous platelet-rich plasma combined with hyaluronic acid. Symptom improvements were noted, but no trials investigated safety parameters.

The eight local estrogen therapy trials were divided into those that considered the therapy to be ineffective in relation to the risk of breast cancer recurrence and those that found the therapy may increase sexual hormone levels in serum. Studies showed symptom improvement, but the intervention is controversial, according to the authors, with different studies showing contradictory outcomes.

Vaginal testosterone was shown to improve quality of life; however, safety data were reported in only one of three studies.

Laser therapy improved VVA symptoms, at least in the short term, and was likely safe and effective based on limited data.

As Dr. Castelo-Branco noted, non-hormonal treatments remain the first-line treatment for VVA, but when these don't provide symptom relief, other options can be considered. "While the data suggest that these therapies are effective for VVA in BCS," the authors note, "safety remains controversial and a major concern with all of these treatments."

Dr. Castelo-Branco said his institution is currently starting two clinical trials to evaluate the safety of the CO2 laser and prasterone in breast cancer patients.

Dr. Marlene Meyers, Founding Director, Perlmutter Cancer Center Survivorship Program at NYU Langone in New York City, commented in an email to Reuters Health, "It is clear that we unfortunately do not know a lot and many clinicians are passionate one way or the other about the acceptance of vaginal estrogen without having the data."

"We know that non-hormonal therapy works to a degree but is not very effective and most people are not happy with the results," she said. "Most oncologists, however, believe it is very safe."

"Everything else is open for discussion," she noted, "largely because we don't have long-term recurrence data, and while quality of life is very important, the overriding goal is survival."

"This article is important because we all need to be on the same page when discussing these options with our patients," she added. "Unfortunately, they can go to different physicians and get different recommendations, based on individual beliefs. The information presented must be factual, honest and allow the patient to make a decision."

"The take-home message is that this must be a joint decision between the patient and doctor taking into account quality of life and potential risk of recurrence based on an individual's risk," Dr. Meyers concluded.

Dr. Jon Pennycuff, an instructor in Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center in Washington DC, also commented by email. "Women who have been diagnosed with breast cancer are living longer, healthier lives due to advances in screening and treatment. Providers should be thinking about ways to incorporate survivorship care for all of our patients, which is emphasized in this article."

"Patients often won't ask about what is available to treat VVA, so it's imperative that we inquire about these symptoms," he told Reuters Health. "Many providers are hesitant to do so because they don't have the information to adequately counsel patients and provide treatment options that are evidence-based, effective, and safe. Having more data to be able to do this is absolutely necessary for providing the best care for our patients."

SOURCE: https://bit.ly/2RhOmld Maturitas, online August 20, 2020.

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